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Study Title & The Sustained Aeration of Infant Lungs (SAIL) Study \\\\\n\\hline Sponsor & National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development \\\\\n\\hline Population & Preterm infants born between 23-26 weeks gestational age \\\\\n\\hline Primary Objective & To determine in preterm infants needing respiratory support at birth, which of two lung opening strategies - either a standard positive-end expiratory pressure /continuous positive airway pressure (PEEP/CPAP) of \\(5-7 cm H _{2} O\\) in the delivery room as compared to early lung recruitment using Sustained Inflation \\(( SI )\\) in the delivery room, will result in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia (BPD) at 36 weeks gestational age \\\\\n\\hline Design and Sample Size & \\begin{tabular}{l}\nThis prospective multi-national randomized controlled trial (RCT) is a two-arm parallel design of two alternative courses of treatment. \\\\\n600 preterm infants - 300 control / 300 intervention\n\\end{tabular} \\\\\n\\hline Inclusion Criteria & Infants who are born in participating NICUs (which do not use prophylactic surfactant) and who fulfill the following inclusion criteria are eligible for enrollment: (a) Gestational age (GA) at least 23 weeks but less than 27 completed weeks by best obstetrical estimate; (b) requiring resuscitation/respiratory intervention at birth - \"apneic, labored breathing, gasping\" (as defined in NRP 2011 AAP 6th Edition p. 45.) \\\\\n\\hline Outcomes and Analytic Approach & \\begin{tabular}{l}\nThe primary outcome to be used for efficacy evaluation is rate of death or BPD at 36 weeks gestation age. Analysis of the primary outcome will be intention-to-treat comparisons between treatment arms. \\\\\nSecondary outcomes include clinical measures collected from the first 10 days of life as well as neurodevelopment and respiratory outcomes at 22-26 months of corrected age in survivors. Secondary outcomes will be analyzed using similar procedures to the primary outcome comparisons between treatment arms.\n\\end{tabular} \\\\\n\\hline Interim Analysis & 2 interim analyses conducted when \\(1 / 3\\) and \\(2 / 3\\) participants complete primary outcome. An additional SAE safety analysis after 100 subjects complete. \\\\\n\\hline Clinical Centers & 21 multi-national sites (USA, Canada, Italy, Germany, Netherlands, Australia, Austria, Singapore, S. 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References","confidence":1,"confidence_rate":1},{"cnt":[[1891,1538],[1942,1538],[1942,1577],[1891,1577]],"region":{"top_left_x":1890,"top_left_y":1538,"width":53,"height":39},"line":66,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6055d42053694b85a123a2d839c7e959","type":"table_of_contents_number","conversion_output":true,"parent_id":"e963b17548884bbc87a3defd35a83d57","text":"49","text_display":" ..... 49","confidence":1,"confidence_rate":1},{"cnt":[[1912,2582],[1942,2582],[1942,2628],[1912,2628]],"region":{"top_left_x":1912,"top_left_y":2582,"width":31,"height":46},"line":67,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"602d283d651e4fc78277bcf7288983f2","type":"page_info","conversion_output":false,"text":"8","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-09","page":9,"lines":[{"cnt":[[168,62],[1222,62],[1222,116],[168,116]],"region":{"top_left_x":167,"top_left_y":62,"width":1056,"height":55},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e1da0ef6874445c8634227e545ae1a5","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) Study","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1491,62],[1916,62],[1916,114],[1491,114]],"region":{"top_left_x":1491,"top_left_y":62,"width":426,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2ab4772222d443288614ea64ee6b8f6","type":"page_info","conversion_output":false,"text":"Version 2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[165,236],[595,236],[595,299],[165,299]],"region":{"top_left_x":165,"top_left_y":236,"width":431,"height":63},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e8677fd33ca4cf1856d1d8762068e94","type":"section_header","conversion_output":false,"children_ids":["05e03f76479e490882d2cc7f763cb6f1"],"text":"","text_display":""},{"cnt":[[172,241],[591,241],[591,294],[172,294]],"region":{"top_left_x":171,"top_left_y":240,"width":420,"height":55},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05e03f76479e490882d2cc7f763cb6f1","type":"text","conversion_output":true,"parent_id":"3e8677fd33ca4cf1856d1d8762068e94","text":"1. Introduction","text_display":"\n\n\\section*{1. Introduction}","confidence":1,"confidence_rate":1},{"cnt":[[168,327],[1927,327],[1927,376],[168,376]],"region":{"top_left_x":167,"top_left_y":326,"width":1761,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2501894808fa481bb813749098d27c2d","type":"text","conversion_output":true,"text":"This research study funded by the NICHD, is a Phase III randomized controlled trial (RCT), which aims to","text_display":"\n\nThis research study funded by the NICHD, is a Phase III randomized controlled trial (RCT), which aims to","confidence":1,"confidence_rate":1},{"cnt":[[168,387],[1946,387],[1946,436],[168,436]],"region":{"top_left_x":167,"top_left_y":386,"width":1780,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7846890c6b640769549a0272140b805","type":"text","conversion_output":true,"text":"provide evidence for changing policy or standard of care. The context of this trial is an unacceptable rate","text_display":" provide evidence for changing policy or standard of care. The context of this trial is an unacceptable rate","confidence":0.99609375,"confidence_rate":0.9999650550809349},{"cnt":[[168,443],[1833,443],[1833,494],[168,494]],"region":{"top_left_x":167,"top_left_y":442,"width":1666,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03f2e70d9990470a8463a6ca4de77e7c","type":"text","conversion_output":true,"text":"of poor long-term outcomes of preterm infants born as Extremely Low Gestational Age Newborns","text_display":" of poor long-term outcomes of preterm infants born as Extremely Low Gestational Age Newborns","confidence":1,"confidence_rate":1},{"cnt":[[168,503],[1931,503],[1931,552],[168,552]],"region":{"top_left_x":167,"top_left_y":502,"width":1765,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"150b83eeaabb44c094e09e82a87bbeaa","type":"text","conversion_output":true,"text":"(ELGAN) \\(<1000 g\\) birthweight (BW), but especially for those born between \\(23-26\\) weeks' gestational age","text_display":" (ELGAN) \\(<1000 g\\) birthweight (BW), but especially for those born between \\(23-26\\) weeks' gestational age","confidence":0.36622231601654676,"confidence_rate":0.9911498841794169},{"cnt":[[168,561],[1901,561],[1901,612],[168,612]],"region":{"top_left_x":167,"top_left_y":560,"width":1735,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e485ff3a206b4ffe930cd17cd1cd7c66","type":"text","conversion_output":true,"text":"(GA). Such infants are the most vulnerable and immature in all organ systems, including the lungs and","text_display":" (GA). Such infants are the most vulnerable and immature in all organ systems, including the lungs and","confidence":1,"confidence_rate":1},{"cnt":[[168,619],[1880,619],[1880,668],[168,668]],"region":{"top_left_x":167,"top_left_y":618,"width":1713,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a700d992a2d443a68f8f85d2112d6260","type":"text","conversion_output":true,"text":"the brain. These infants are at high risk of death and bronchopulmonary dysplasia (BPD) during their","text_display":" the brain. These infants are at high risk of death and bronchopulmonary dysplasia (BPD) during their","confidence":1,"confidence_rate":1},{"cnt":[[168,679],[1897,679],[1897,728],[168,728]],"region":{"top_left_x":167,"top_left_y":678,"width":1731,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1cf41f9516344c7ba1c4a2995db78b13","type":"text","conversion_output":true,"text":"initial hospitalization, neurodevelopmental impairment (NDI) and pulmonary problems in infancy and","text_display":" initial hospitalization, neurodevelopmental impairment (NDI) and pulmonary problems in infancy and","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[168,735],[357,735],[357,780],[168,780]],"region":{"top_left_x":167,"top_left_y":734,"width":190,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f29bc07a6294e1a908b01c2d532facb","type":"text","conversion_output":true,"text":"childhood.","text_display":" childhood.","confidence":1,"confidence_rate":1},{"cnt":[[168,829],[1938,829],[1938,879],[168,879]],"region":{"top_left_x":167,"top_left_y":829,"width":1771,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ef2c1c0b3a54b5da317fc955f241ede","type":"text","conversion_output":true,"text":"The SAIL trial focuses on facilitating the difficult transition of these most vulnerable infants from a liquid","text_display":"\n\nThe SAIL trial focuses on facilitating the difficult transition of these most vulnerable infants from a liquid","confidence":0.99951171875,"confidence_rate":0.9999957530481652},{"cnt":[[168,887],[1940,887],[1940,939],[168,939]],"region":{"top_left_x":167,"top_left_y":887,"width":1774,"height":52},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a1ed88e473d428d9855cf11601b932c","type":"text","conversion_output":true,"text":"filled in-utero lung to an ex-utero air-filled lung. Sustained Inflation (SI) is a promising delivery room (DR)","text_display":" filled in-utero lung to an ex-utero air-filled lung. Sustained Inflation (SI) is a promising delivery room (DR)","confidence":0.976214882102795,"confidence_rate":0.9997924995422923},{"cnt":[[168,947],[1919,947],[1919,995],[168,995]],"region":{"top_left_x":167,"top_left_y":947,"width":1752,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d0b94640d314beeae4fcc4d1b3f6416","type":"text","conversion_output":true,"text":"intervention, with evidence of short-term efficacy with minimal risk of additional harm beyond current","text_display":" intervention, with evidence of short-term efficacy with minimal risk of additional harm beyond current","confidence":1,"confidence_rate":1},{"cnt":[[168,1005],[1919,1005],[1919,1055],[168,1055]],"region":{"top_left_x":167,"top_left_y":1005,"width":1752,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72477de3dc534be7a3259b0d4b8fa535","type":"text","conversion_output":true,"text":"standard accepted Newborn Resuscitation Programme (NRP) Guidelines. This protocol proposes a fully","text_display":" standard accepted Newborn Resuscitation Programme (NRP) Guidelines. This protocol proposes a fully","confidence":1,"confidence_rate":1},{"cnt":[[168,1066],[1886,1066],[1886,1115],[168,1115]],"region":{"top_left_x":167,"top_left_y":1065,"width":1720,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d8866208fd44253ba444dcb4a074800","type":"text","conversion_output":true,"text":"informed consenting procedure. We propose to evaluate the impact of a SI in the DR on the need for","text_display":" informed consenting procedure. We propose to evaluate the impact of a SI in the DR on the need for","confidence":0.984870433807373,"confidence_rate":0.9998519994410863},{"cnt":[[168,1121],[1949,1121],[1949,1171],[168,1171]],"region":{"top_left_x":167,"top_left_y":1121,"width":1782,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"168e7af898e340248eab5e6ed2099600","type":"text","conversion_output":true,"text":"mechanical ventilation in the first week of life which would also impact mortality rates and the incidence","text_display":" mechanical ventilation in the first week of life which would also impact mortality rates and the incidence","confidence":1,"confidence_rate":1},{"cnt":[[168,1182],[518,1182],[518,1231],[168,1231]],"region":{"top_left_x":167,"top_left_y":1181,"width":351,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b213dc589fb442ea8c4cd2d1a2500fe","type":"text","conversion_output":true,"text":"and severity of BPD.","text_display":" and severity of BPD.","confidence":1,"confidence_rate":1},{"cnt":[[163,1268],[518,1268],[518,1330],[163,1330]],"region":{"top_left_x":163,"top_left_y":1267,"width":355,"height":63},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe5db9f3b2de4cd88204a94cc8f6a3e6","type":"section_header","conversion_output":false,"children_ids":["9d284d39e804415b9805ee54c0dded23"],"text":"","text_display":""},{"cnt":[[168,1272],[513,1272],[513,1326],[168,1326]],"region":{"top_left_x":167,"top_left_y":1271,"width":347,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d284d39e804415b9805ee54c0dded23","type":"text","conversion_output":true,"parent_id":"fe5db9f3b2de4cd88204a94cc8f6a3e6","text":"1.1. Background","text_display":"\n\n\\subsection*{1.1. Background}","confidence":1,"confidence_rate":1},{"cnt":[[168,1345],[1858,1345],[1858,1394],[168,1394]],"region":{"top_left_x":167,"top_left_y":1344,"width":1692,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a6e6aa484c24c958a8525efea0fd863","type":"text","conversion_output":true,"text":"Extreme prematurity makes the transition from intra-uterine life to extra-uterine life more difficult.","text_display":"\n\nExtreme prematurity makes the transition from intra-uterine life to extra-uterine life more difficult.","confidence":1,"confidence_rate":1},{"cnt":[[168,1403],[1858,1403],[1858,1452],[168,1452]],"region":{"top_left_x":167,"top_left_y":1402,"width":1692,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c8a15400749480599f7b313f0e7e0f4","type":"text","conversion_output":true,"text":"During this transition - termed the 'Golden Hour' - the newborn must generate the critical opening","text_display":" During this transition - termed the 'Golden Hour' - the newborn must generate the critical opening","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[168,1461],[1867,1461],[1867,1510],[168,1510]],"region":{"top_left_x":167,"top_left_y":1460,"width":1700,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15b2942a609a404dbad3297a21ee61d6","type":"text","conversion_output":true,"text":"pressure to aerate her/his lungs, remove the amniotic fluid and lung liquid to fill the lung with air to","text_display":" pressure to aerate her/his lungs, remove the amniotic fluid and lung liquid to fill the lung with air to","confidence":1,"confidence_rate":1},{"cnt":[[168,1521],[1880,1521],[1880,1571],[168,1571]],"region":{"top_left_x":167,"top_left_y":1521,"width":1713,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a2c73f89ea546188c71f7ffbf300a43","type":"text","conversion_output":true,"text":"enable extra-uterine life. This requires an enormous physiological change and energy cost. Normally,","text_display":" enable extra-uterine life. This requires an enormous physiological change and energy cost. Normally,","confidence":1,"confidence_rate":1},{"cnt":[[168,1577],[1944,1577],[1944,1626],[168,1626]],"region":{"top_left_x":167,"top_left_y":1576,"width":1778,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5d9db0698214a1981a3fccb52c37100","type":"text","conversion_output":true,"text":"high ambient oxygen, cord clamping, cold and other external stimuli will trigger breathing. However, the","text_display":" high ambient oxygen, cord clamping, cold and other external stimuli will trigger breathing. However, the","confidence":1,"confidence_rate":1},{"cnt":[[168,1637],[1886,1637],[1886,1687],[168,1687]],"region":{"top_left_x":167,"top_left_y":1637,"width":1720,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"765f15bace2948599e25a4d911af2142","type":"text","conversion_output":true,"text":"ELGAN infant has a compliant chest wall prone to collapse and weak respiratory muscles, and cannot","text_display":" ELGAN infant has a compliant chest wall prone to collapse and weak respiratory muscles, and cannot","confidence":1,"confidence_rate":1},{"cnt":[[168,1693],[1944,1693],[1944,1742],[168,1742]],"region":{"top_left_x":167,"top_left_y":1692,"width":1778,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38b1696b5375482d853a0bf4c33a5977","type":"text","conversion_output":true,"text":"cope with the high work of breathing. This work is increased in the presence of retained amniotic liquid.","text_display":" cope with the high work of breathing. This work is increased in the presence of retained amniotic liquid.","confidence":1,"confidence_rate":1},{"cnt":[[168,1753],[1949,1753],[1949,1803],[168,1803]],"region":{"top_left_x":167,"top_left_y":1753,"width":1782,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43c5e893206d4b82832307dcf3ae87aa","type":"text","conversion_output":true,"text":"Most ELGANs are born by cesarean delivery, often without adequate labor. This retards the activation of","text_display":" Most ELGANs are born by cesarean delivery, often without adequate labor. This retards the activation of","confidence":1,"confidence_rate":1},{"cnt":[[168,1811],[1858,1811],[1858,1861],[168,1861]],"region":{"top_left_x":167,"top_left_y":1811,"width":1692,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74fbc0065ebc4fa0a40145e764b0ed50","type":"text","conversion_output":true,"text":"the sodium channels (ENaCs), that switch the lung from a Na secreting to a sodium absorbing state,","text_display":" the sodium channels (ENaCs), that switch the lung from a Na secreting to a sodium absorbing state,","confidence":1,"confidence_rate":1},{"cnt":[[168,1869],[672,1869],[672,1919],[168,1919]],"region":{"top_left_x":167,"top_left_y":1869,"width":506,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9306813e66f4692a90b64162bb7e7a3","type":"text","conversion_output":true,"text":"ensuring residual lung water.","text_display":" ensuring residual lung water.","confidence":1,"confidence_rate":1},{"cnt":[[168,1964],[1766,1964],[1766,2013],[168,2013]],"region":{"top_left_x":167,"top_left_y":1963,"width":1600,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3fe674b15cf84c0a9fd6ef74ef51160a","type":"text","conversion_output":true,"text":"We know that establishing uniform aeration also called an 'open lung' prevents lung injury.(1)","text_display":"\n\nWe know that establishing uniform aeration also called an 'open lung' prevents lung injury.(1)","confidence":0.9960954189300537,"confidence_rate":0.9999604833682},{"cnt":[[168,2022],[1944,2022],[1944,2071],[168,2071]],"region":{"top_left_x":167,"top_left_y":2021,"width":1778,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e067e49664d44b8ca1acc4bcbb493f48","type":"text","conversion_output":true,"text":"Performing this well in the DR provides the best start to the critical first days of life. Yet the best manner","text_display":" Performing this well in the DR provides the best start to the critical first days of life. Yet the best manner","confidence":1,"confidence_rate":1},{"cnt":[[168,2080],[1820,2080],[1820,2129],[168,2129]],"region":{"top_left_x":167,"top_left_y":2079,"width":1653,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"267fc3897ddc40698b0fe4909575548f","type":"text","conversion_output":true,"text":"to achieve this is poorly studied. In this trial we compare two alternative methods that have both","text_display":" to achieve this is poorly studied. In this trial we compare two alternative methods that have both","confidence":1,"confidence_rate":1},{"cnt":[[168,2140],[1867,2140],[1867,2189],[168,2189]],"region":{"top_left_x":167,"top_left_y":2139,"width":1700,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7cb86124c384d9fa19d338124183779","type":"text","conversion_output":true,"text":"received an AAP ILCOR-2010 endorsement. Positive-end expiratory pressure (PEEP) is now routinely","text_display":" received an AAP ILCOR-2010 endorsement. Positive-end expiratory pressure (PEEP) is now routinely","confidence":0.9970703125,"confidence_rate":0.9999709510413867},{"cnt":[[168,2196],[1923,2196],[1923,2245],[168,2245]],"region":{"top_left_x":167,"top_left_y":2195,"width":1756,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d51072d98964d1187553d366c44f91f","type":"text","conversion_output":true,"text":"used in the DR to establish and maintain functional residual capacity (FRC) and its use is well supported","text_display":" used in the DR to establish and maintain functional residual capacity (FRC) and its use is well supported","confidence":1,"confidence_rate":1},{"cnt":[[168,2256],[1927,2256],[1927,2305],[168,2305]],"region":{"top_left_x":167,"top_left_y":2255,"width":1761,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"101af9d132464ee09778821155258be2","type":"text","conversion_output":true,"text":"by data. There is some weak evidence that an alternative method, SI may help. Indeed in many parts of","text_display":" by data. There is some weak evidence that an alternative method, SI may help. Indeed in many parts of","confidence":0.9951210021972656,"confidence_rate":0.999953860130807},{"cnt":[[168,2314],[1888,2314],[1888,2365],[168,2365]],"region":{"top_left_x":167,"top_left_y":2313,"width":1722,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e964e210cc824248b6d622c310afade7","type":"text","conversion_output":true,"text":"Europe the practice of SI has become a standard approach (Appendix 1) - Letters from Ulm Germany","text_display":" Europe the practice of SI has become a standard approach (Appendix 1) - Letters from Ulm Germany","confidence":1,"confidence_rate":1},{"cnt":[[168,2374],[1946,2374],[1946,2426],[168,2426]],"region":{"top_left_x":167,"top_left_y":2374,"width":1780,"height":52},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97707a0c18c04aa6ba56d568b6f4cc26","type":"text","conversion_output":true,"text":"and Leiden Netherlands). However, a lack of high quality evidence and uncertainty about its safety make","text_display":" and Leiden Netherlands). However, a lack of high quality evidence and uncertainty about its safety make","confidence":1,"confidence_rate":1},{"cnt":[[168,2432],[1171,2432],[1171,2481],[168,2481]],"region":{"top_left_x":167,"top_left_y":2432,"width":1004,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7096c8eff3ef4039a95bd0eccd46c6b2","type":"text","conversion_output":true,"text":"the current creep into more general practice, problematic.","text_display":" the current creep into more general practice, problematic.","confidence":0.9990234375,"confidence_rate":0.9999844915544187},{"cnt":[[1921,2643],[1955,2643],[1955,2696],[1921,2696]],"region":{"top_left_x":1920,"top_left_y":2642,"width":36,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f7b2a4c88d2421ea5f46be0bf0e6910","type":"page_info","conversion_output":false,"text":"9","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-10","page":10,"lines":[{"cnt":[[168,60],[1222,60],[1222,116],[168,116]],"region":{"top_left_x":167,"top_left_y":60,"width":1056,"height":57},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d467da7dea594feeaae4403bbc14f5c0","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) Study","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1491,62],[1916,62],[1916,114],[1491,114]],"region":{"top_left_x":1491,"top_left_y":62,"width":426,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c06c400649949fa965c19cc627b5cd5","type":"page_info","conversion_output":false,"text":"Version 2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[168,176],[1893,176],[1893,230],[168,230]],"region":{"top_left_x":167,"top_left_y":176,"width":1726,"height":54},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5e8e3106f35c41ce9b1c456572a44632","type":"text","conversion_output":true,"text":"The underlying trial rationale is that augmenting PEEP by a SI will facilitate clearance of lung fluid and","text_display":"\n\nThe underlying trial rationale is that augmenting PEEP by a SI will facilitate clearance of lung fluid and","confidence":1,"confidence_rate":1},{"cnt":[[168,234],[1766,234],[1766,288],[168,288]],"region":{"top_left_x":167,"top_left_y":234,"width":1600,"height":54},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d1667f80c886469bb091de0054fe4631","type":"text","conversion_output":true,"text":"more effectively develop a stable FRC. The SAIL trial will promote evidence-based practice, by","text_display":" more effectively develop a stable FRC. The SAIL trial will promote evidence-based practice, by","confidence":1,"confidence_rate":1},{"cnt":[[168,294],[1938,294],[1938,346],[168,346]],"region":{"top_left_x":167,"top_left_y":294,"width":1771,"height":52},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bbcbd318a3e64b4aa39f78a6b88abd9d","type":"text","conversion_output":true,"text":"conducting a 600 patient prospective multi-center trial targeting clinically important outcomes. SAIL will","text_display":" conducting a 600 patient prospective multi-center trial targeting clinically important outcomes. SAIL will","confidence":1,"confidence_rate":1},{"cnt":[[168,352],[1938,352],[1938,406],[168,406]],"region":{"top_left_x":167,"top_left_y":352,"width":1771,"height":55},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"232c324ad165460b80983bdb8b3c2008","type":"text","conversion_output":true,"text":"randomize eligible infants to one of two methods of ensuring early DR lung aeration: the initial delivery","text_display":" randomize eligible infants to one of two methods of ensuring early DR lung aeration: the initial delivery","confidence":0.99951171875,"confidence_rate":0.9999955600053285},{"cnt":[[168,412],[1944,412],[1944,462],[168,462]],"region":{"top_left_x":167,"top_left_y":412,"width":1778,"height":50},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"50ecbdffc66f44e4b9b442d058697605","type":"text","conversion_output":true,"text":"of PEEP alone; or PEEP supplemented by SI. The combined primary outcome, BPD or death at 36 weeks,","text_display":" of PEEP alone; or PEEP supplemented by SI. The combined primary outcome, BPD or death at 36 weeks,","confidence":0.9990234375,"confidence_rate":0.9999907826873115},{"cnt":[[168,468],[1949,468],[1949,522],[168,522]],"region":{"top_left_x":167,"top_left_y":468,"width":1782,"height":55},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0145bc8bea7b4bdf8d4e3adda4048b10","type":"text","conversion_output":true,"text":"is well established, robust and clinically meaningful. Treatment assignment will be masked at the time of","text_display":" is well established, robust and clinically meaningful. Treatment assignment will be masked at the time of","confidence":1,"confidence_rate":1},{"cnt":[[168,529],[1835,529],[1835,580],[168,580]],"region":{"top_left_x":167,"top_left_y":528,"width":1668,"height":53},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"85ae6f45478c4c0db399d09e95f47b2a","type":"text","conversion_output":true,"text":"developmental follow-up and the outcome of BPD will be acording to a blinded assessment of the","text_display":" developmental follow-up and the outcome of BPD will be acording to a blinded assessment of the","confidence":1,"confidence_rate":1},{"cnt":[[168,580],[1854,580],[1854,640],[168,640]],"region":{"top_left_x":167,"top_left_y":580,"width":1688,"height":61},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0cc5dbd90759405db4bda9ada0fca619","type":"text","conversion_output":true,"text":"Oxygen Reduction Test (ORT). \\({ }^{1}\\) The SAIL trial addresses two unanswered, but important questions:","text_display":" Oxygen Reduction Test (ORT). \\({ }^{1}\\) The SAIL trial addresses two unanswered, but important questions:","confidence":0.99853515625,"confidence_rate":0.9999867936215969},{"cnt":[[168,679],[1912,679],[1912,733],[168,733]],"region":{"top_left_x":167,"top_left_y":678,"width":1746,"height":55},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"300908c327fa473f93e70604074ed71c","type":"text","conversion_output":true,"text":"Firstly, \"In preterms \\(23-26\\) weeks (GA) who require resuscitation and/or respiratory support in the DR,","text_display":"\n\nFirstly, \"In preterms \\(23-26\\) weeks (GA) who require resuscitation and/or respiratory support in the DR,","confidence":0.5418513255150045,"confidence_rate":0.994444908516523},{"cnt":[[168,739],[1938,739],[1938,788],[168,788]],"region":{"top_left_x":167,"top_left_y":739,"width":1771,"height":50},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"73d76dcd912d485bbd0944970f26c7b4","type":"text","conversion_output":true,"text":"which of two alternative strategies to achieve lung aeration results in the lowest rate of death or BPD at","text_display":" which of two alternative strategies to achieve lung aeration results in the lowest rate of death or BPD at","confidence":1,"confidence_rate":1},{"cnt":[[168,797],[662,797],[662,849],[168,849]],"region":{"top_left_x":167,"top_left_y":797,"width":495,"height":52},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d240c333057845268f98b30cc5fbb142","type":"text","conversion_output":true,"text":"36 corrected weeks of age?\"","text_display":" 36 corrected weeks of age?\"","confidence":0.9990234375,"confidence_rate":0.9999684830886739},{"cnt":[[168,889],[1893,889],[1893,943],[168,943]],"region":{"top_left_x":167,"top_left_y":889,"width":1726,"height":55},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"238fe665b2a74c44a9d173bce30d073c","type":"text","conversion_output":true,"text":"Secondly, \"In preterms \\(23-26\\) weeks (GA) who require resuscitation and/or respiratory support in the","text_display":"\n\nSecondly, \"In preterms \\(23-26\\) weeks (GA) who require resuscitation and/or respiratory support in the","confidence":0.4629804861901903,"confidence_rate":0.9928289164408801},{"cnt":[[168,950],[1820,950],[1820,999],[168,999]],"region":{"top_left_x":167,"top_left_y":949,"width":1653,"height":51},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6fb98e30c62847e4840e0ea3d6bf1121","type":"text","conversion_output":true,"text":"DR, what are the safety profiles of 2 currently used methods in the DR to achieve lung aeration?\"","text_display":" DR, what are the safety profiles of 2 currently used methods in the DR to achieve lung aeration?\"","confidence":1,"confidence_rate":1},{"cnt":[[168,1042],[1888,1042],[1888,1094],[168,1094]],"region":{"top_left_x":167,"top_left_y":1041,"width":1722,"height":53},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"150b785bbbec4b4f8a3f74cc622c9c00","type":"text","conversion_output":true,"text":"In addition to this primary outcome, we will describe several clinically relevant and/or physiologically","text_display":"\n\nIn addition to this primary outcome, we will describe several clinically relevant and/or physiologically","confidence":1,"confidence_rate":1},{"cnt":[[168,1100],[1953,1100],[1953,1154],[168,1154]],"region":{"top_left_x":167,"top_left_y":1100,"width":1786,"height":54},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0cbb4d42623a44f7abc285e551a8b2df","type":"text","conversion_output":true,"text":"relevant secondary outcomes, including: \\(FiO _{2}\\), respiratory support, surfactant use, radiographic evidence","text_display":" relevant secondary outcomes, including: \\(FiO _{2}\\), respiratory support, surfactant use, radiographic evidence","confidence":0.9712052345275879,"confidence_rate":0.9997624878126088},{"cnt":[[168,1160],[1824,1160],[1824,1210],[168,1210]],"region":{"top_left_x":167,"top_left_y":1160,"width":1658,"height":50},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c159c432000444f1938927c6c141a33c","type":"text","conversion_output":true,"text":"of RDS, \\% of infants ever intubated, head ultrasound, duration of respiratory support; respiratory","text_display":" of RDS, \\% of infants ever intubated, head ultrasound, duration of respiratory support; respiratory","confidence":0.998535871389322,"confidence_rate":0.999985774843952},{"cnt":[[168,1216],[947,1216],[947,1270],[168,1270]],"region":{"top_left_x":167,"top_left_y":1216,"width":781,"height":54},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a4a4bf04ddf4e898ee7cf94f847b5fe","type":"text","conversion_output":true,"text":"severity score ( \\(FIO _{2} \\times\\) mean airway pressure).","text_display":" severity score ( \\(FIO _{2} \\times\\) mean airway pressure).","confidence":0.9936618763022125,"confidence_rate":0.9998990797772233},{"cnt":[[168,1311],[1927,1311],[1927,1360],[168,1360]],"region":{"top_left_x":167,"top_left_y":1310,"width":1761,"height":50},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c1ac5ec366d74a93971315f730acc0cb","type":"text","conversion_output":true,"text":"There are two defined ancilliary studies that will be conducted within the trial. At one site (Ulm) we will","text_display":"\n\nThere are two defined ancilliary studies that will be conducted within the trial. At one site (Ulm) we will","confidence":0.99853515625,"confidence_rate":0.9999869115349181},{"cnt":[[168,1371],[1953,1371],[1953,1420],[168,1420]],"region":{"top_left_x":167,"top_left_y":1370,"width":1786,"height":51},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7bd4cd170bb44c5f96044418cb38bf86","type":"text","conversion_output":true,"text":"have niroscopy brain recordings, and at several sites, we will obtain flow volume pressure records during","text_display":" have niroscopy brain recordings, and at several sites, we will obtain flow volume pressure records during","confidence":1,"confidence_rate":1},{"cnt":[[168,1429],[548,1429],[548,1474],[168,1474]],"region":{"top_left_x":167,"top_left_y":1428,"width":381,"height":46},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"17b3375ff920447d96a469c5168eb980","type":"text","conversion_output":true,"text":"and after SI in the DR.","text_display":" and after SI in the DR.","confidence":0.9501953125,"confidence_rate":0.9981771019500719},{"cnt":[[232,1521],[1869,1521],[1869,1571],[232,1571]],"region":{"top_left_x":232,"top_left_y":1521,"width":1638,"height":50},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"00d0d5c2ca3c46f78fedb71f943af051","type":"text","conversion_output":true,"text":"- Thousands of babies per year die or develop BPD in the US. BPD is a costly chronic childhood","text_display":"\n- Thousands of babies per year die or develop BPD in the US. BPD is a costly chronic childhood","confidence":1,"confidence_rate":1},{"cnt":[[294,1577],[1820,1577],[1820,1631],[294,1631]],"region":{"top_left_x":294,"top_left_y":1576,"width":1526,"height":55},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e5111e806c184588927cc401cc9d2a09","type":"text","conversion_output":true,"text":"illness. In a study of health care expenditure among children, BPD ranked second for total","text_display":" illness. In a study of health care expenditure among children, BPD ranked second for total","confidence":1,"confidence_rate":1},{"cnt":[[294,1637],[1566,1637],[1566,1691],[294,1691]],"region":{"top_left_x":294,"top_left_y":1637,"width":1273,"height":54},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"211433c3c94140a4ab7aaa8ed8f5a0f4","type":"text","conversion_output":true,"text":"payments of \\$2.4 billion annually (Appendix 2- http://www.lung.org/lung-","text_display":" payments of \\$2.4 billion annually (Appendix 2- http://www.lung.org/lung-","confidence":0.8649715948763514,"confidence_rate":0.9981178953210793},{"cnt":[[292,1697],[1841,1697],[1841,1747],[292,1747]],"region":{"top_left_x":292,"top_left_y":1697,"width":1550,"height":50},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1df4407a6bd34438a6341497be5c54cc","type":"text","conversion_output":true,"text":"disease/bronchopulmonary-dysplasia/). Survivors with BPD often suffer serious pulmonary","text_display":"disease/bronchopulmonary-dysplasia/). Survivors with BPD often suffer serious pulmonary","confidence":1,"confidence_rate":1},{"cnt":[[292,1755],[1843,1755],[1843,1807],[292,1807]],"region":{"top_left_x":292,"top_left_y":1755,"width":1552,"height":52},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"df4062a5287f43b88bbde6cc5e78683c","type":"text","conversion_output":true,"text":"and/or neurodevelopmental sequelae. While extremely-low birth-weight (<1000 g at birth)","text_display":" and/or neurodevelopmental sequelae. While extremely-low birth-weight (<1000 g at birth)","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[294,1813],[1914,1813],[1914,1863],[294,1863]],"region":{"top_left_x":294,"top_left_y":1813,"width":1621,"height":50},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b3ad08e21dc54d5b931304adeb55c80b","type":"text","conversion_output":true,"text":"infants are at high risk of death or BPD, the most vulnerable are those born between 23 and 26","text_display":" infants are at high risk of death or BPD, the most vulnerable are those born between 23 and 26","confidence":1,"confidence_rate":1},{"cnt":[[292,1865],[1884,1865],[1884,1923],[292,1923]],"region":{"top_left_x":292,"top_left_y":1864,"width":1593,"height":59},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0112fe26b0364cc891afbc91ffce8517","type":"text","conversion_output":true,"text":"weeks' GA. In this population, the rate of death or BPD was \\(68 \\%\\) in the recent SUPPORT trial. \\({ }^{2}\\)","text_display":" weeks' GA. In this population, the rate of death or BPD was \\(68 \\%\\) in the recent SUPPORT trial. \\({ }^{2}\\)","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[294,1929],[1777,1929],[1777,1981],[294,1981]],"region":{"top_left_x":294,"top_left_y":1929,"width":1483,"height":52},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a0aa05b7e89d48c1b880ea556f1909e4","type":"text","conversion_output":true,"text":"Despite a significant amount of research designed to prevent BPD, there has been little","text_display":" Despite a significant amount of research designed to prevent BPD, there has been little","confidence":1,"confidence_rate":1},{"cnt":[[292,1989],[1815,1989],[1815,2039],[292,2039]],"region":{"top_left_x":292,"top_left_y":1989,"width":1524,"height":50},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc9295f198894bf6b834ada77830a0b7","type":"text","conversion_output":true,"text":"improvement in the incidence or severity of the disease. Novel interventions are urgently","text_display":" improvement in the incidence or severity of the disease. Novel interventions are urgently","confidence":1,"confidence_rate":1},{"cnt":[[292,2050],[443,2050],[443,2095],[292,2095]],"region":{"top_left_x":292,"top_left_y":2049,"width":151,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4cee9f044e32467abd6a86dd63524661","type":"text","conversion_output":true,"text":"needed.","text_display":" needed.","confidence":1,"confidence_rate":1},{"cnt":[[168,2140],[1863,2140],[1863,2191],[168,2191]],"region":{"top_left_x":167,"top_left_y":2139,"width":1696,"height":53},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f04dff1e7fad459eb214f4bed0a1bc78","type":"text","conversion_output":true,"text":"The SUPPORT Trial evaluated both continuous positive airway pressure (CPAP) for infants breathing","text_display":"\n\nThe SUPPORT Trial evaluated both continuous positive airway pressure (CPAP) for infants breathing","confidence":1,"confidence_rate":1},{"cnt":[[168,2200],[1901,2200],[1901,2249],[168,2249]],"region":{"top_left_x":167,"top_left_y":2200,"width":1735,"height":50},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bea0f777a37c47e28566aee63effce31","type":"text","conversion_output":true,"text":"spontaneously, and PEEP during intermittent positive pressure ventilation in the DR. Both approaches","text_display":" spontaneously, and PEEP during intermittent positive pressure ventilation in the DR. Both approaches","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[168,2258],[1876,2258],[1876,2307],[168,2307]],"region":{"top_left_x":167,"top_left_y":2258,"width":1709,"height":50},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d98f1f68daf0434c9e09536f44dd06e0","type":"text","conversion_output":true,"text":"help to establish and maintain FRC, which aerates the newborn lung. Several trials demonstrate that","text_display":" help to establish and maintain FRC, which aerates the newborn lung. Several trials demonstrate that","confidence":1,"confidence_rate":1},{"cnt":[[168,2316],[1712,2316],[1712,2365],[168,2365]],"region":{"top_left_x":167,"top_left_y":2316,"width":1546,"height":50},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7badeba47321431ab8104f21b8bcb9b6","type":"text","conversion_output":true,"text":"CPAP can be safely delivered in the DR, but do not reduce the incidence or severity of BPD.","text_display":" CPAP can be safely delivered in the DR, but do not reduce the incidence or severity of BPD.","confidence":1,"confidence_rate":1},{"cnt":[[168,2411],[1910,2411],[1910,2460],[168,2460]],"region":{"top_left_x":167,"top_left_y":2410,"width":1743,"height":50},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a8889c2b4239453ea47e2f938d643478","type":"text","conversion_output":true,"text":"These have been taken into account in the design of this trial. At the time of submission of the trial for","text_display":"\n\nThese have been taken into account in the design of this trial. At the time of submission of the trial for","confidence":0.99951171875,"confidence_rate":0.9999956000051925},{"cnt":[[168,2469],[1467,2469],[1467,2520],[168,2520]],"region":{"top_left_x":167,"top_left_y":2468,"width":1301,"height":53},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"10324d5cc7834292a3ae416c0ac794f5","type":"text","conversion_output":true,"text":"peer-reviewed funding, the ILCOR-AAP 2010 statement (Appendix 3) stated:","text_display":" peer-reviewed funding, the ILCOR-AAP 2010 statement (Appendix 3) stated:","confidence":0.99951171875,"confidence_rate":0.9999938950124091},{"cnt":[[1904,2643],[1957,2643],[1957,2696],[1904,2696]],"region":{"top_left_x":1903,"top_left_y":2642,"width":55,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ee669a8c5124e7285f026432b7d4d84","type":"page_info","conversion_output":false,"text":"10","text_display":"","confidence":0.99951171875,"confidence_rate":0.9997558295653994}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-11","page":11,"lines":[{"cnt":[[168,62],[1222,62],[1222,116],[168,116]],"region":{"top_left_x":167,"top_left_y":62,"width":1056,"height":55},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a03b9838a74d432481b144251a5d93af","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) Study","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1491,62],[1916,62],[1916,114],[1491,114]],"region":{"top_left_x":1491,"top_left_y":62,"width":426,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6108c1d8c9bd43afb7e9551a9d40a20e","type":"page_info","conversion_output":false,"text":"Version 2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[168,176],[1876,176],[1876,230],[168,230]],"region":{"top_left_x":167,"top_left_y":176,"width":1709,"height":54},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"89346b0fd72a40ca84c640fd828630e6","type":"text","conversion_output":true,"text":"\"End-Expiratory Pressure: \"There is no evidence to support or refute the use of CPAP in the delivery","text_display":"\n\"End-Expiratory Pressure: \"There is no evidence to support or refute the use of CPAP in the delivery","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[168,234],[1850,234],[1850,288],[168,288]],"region":{"top_left_x":167,"top_left_y":234,"width":1683,"height":54},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b200c1883b86452f9619499dc462f549","type":"text","conversion_output":true,"text":"room in the term baby with respiratory distress.\" (Page 1404 column 3). ILCOR states earlier in this","text_display":" room in the term baby with respiratory distress.\" (Page 1404 column 3). ILCOR states earlier in this","confidence":0.98388671875,"confidence_rate":0.9998495991652414},{"cnt":[[168,294],[1130,294],[1130,346],[168,346]],"region":{"top_left_x":167,"top_left_y":294,"width":964,"height":52},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"53089a4d9c044f22893735c1dcbc911d","type":"text","conversion_output":true,"text":"section, that in preterm babies the situation is different:","text_display":" section, that in preterm babies the situation is different:","confidence":1,"confidence_rate":1},{"cnt":[[168,352],[1953,352],[1953,404],[168,404]],"region":{"top_left_x":167,"top_left_y":352,"width":1786,"height":52},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5f487e7b62214782a73e392d68f5cc2c","type":"text","conversion_output":true,"text":"\"Although positive end-expiratory pressure (PEEP) has been shown to be beneficial and its use is routine","text_display":"\n\"Although positive end-expiratory pressure (PEEP) has been shown to be beneficial and its use is routine","confidence":0.99951171875,"confidence_rate":0.9999955192715237},{"cnt":[[168,412],[1949,412],[1949,462],[168,462]],"region":{"top_left_x":167,"top_left_y":412,"width":1782,"height":50},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8a69659aab2a436d896e3fd927f2ad92","type":"text","conversion_output":true,"text":"during mechanical ventilation of neonates in intensive care units, there have been no studies specifically","text_display":" during mechanical ventilation of neonates in intensive care units, there have been no studies specifically","confidence":1,"confidence_rate":1},{"cnt":[[168,473],[1824,473],[1824,522],[168,522]],"region":{"top_left_x":167,"top_left_y":472,"width":1658,"height":51},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c0a86f0ca7a64229b8998b76149fa80f","type":"text","conversion_output":true,"text":"examining PEEP versus no PEEP when PPV is used during establishment of an FRC following birth.","text_display":" examining PEEP versus no PEEP when PPV is used during establishment of an FRC following birth.","confidence":1,"confidence_rate":1},{"cnt":[[168,529],[1919,529],[1919,580],[168,580]],"region":{"top_left_x":167,"top_left_y":528,"width":1752,"height":53},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7850219ff4794f6dbb87a854478cb96d","type":"text","conversion_output":true,"text":"Nevertheless, PEEP is likely to be beneficial and should be used if suitable equipment is available (Class","text_display":" Nevertheless, PEEP is likely to be beneficial and should be used if suitable equipment is available (Class","confidence":1,"confidence_rate":1},{"cnt":[[168,589],[1803,589],[1803,638],[168,638]],"region":{"top_left_x":167,"top_left_y":588,"width":1636,"height":51},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cfc24b0ff6524791aed336b925600ce8","type":"text","conversion_output":true,"text":"IIb, LOE C). PEEP can easily be given with a flow-inflating bag or T-piece resuscitator, mechanical","text_display":" IIb, LOE C). PEEP can easily be given with a flow-inflating bag or T-piece resuscitator, mechanical","confidence":0.9892673492431641,"confidence_rate":0.9998962490258109},{"cnt":[[168,645],[1794,645],[1794,698],[168,698]],"region":{"top_left_x":167,"top_left_y":644,"width":1627,"height":55},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"83ef96ef446b411aa881cacfb602eaae","type":"text","conversion_output":true,"text":"ventilation (Class IIb, LOE B). The most appropriate choice may be guided by local expertise and","text_display":" ventilation (Class IIb, LOE B). The most appropriate choice may be guided by local expertise and","confidence":1,"confidence_rate":1},{"cnt":[[168,705],[827,705],[827,754],[168,754]],"region":{"top_left_x":167,"top_left_y":704,"width":661,"height":51},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c1395e8b2224f77965963ad00623c2b","type":"text","conversion_output":true,"text":"preferences\" (Page 1404 Column 2-3).","text_display":" preferences\" (Page 1404 Column 2-3).","confidence":1,"confidence_rate":1},{"cnt":[[230,776],[1850,776],[1850,827],[230,827]],"region":{"top_left_x":229,"top_left_y":775,"width":1621,"height":53},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"20989090c59c4945b8961d906c9379b9","type":"text","conversion_output":true,"text":"- After the meta-analysis contained in (Appendix 4) of pooled results of the three main trials","text_display":"\n- After the meta-analysis contained in (Appendix 4) of pooled results of the three main trials","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[294,834],[1863,834],[1863,883],[294,883]],"region":{"top_left_x":294,"top_left_y":833,"width":1569,"height":51},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2de62281fc37403f9a49113e9a37b4ff","type":"text","conversion_output":true,"text":"evaluating CPAP vs other approaches for such small infants in the DR - it was clear the point","text_display":" evaluating CPAP vs other approaches for such small infants in the DR - it was clear the point","confidence":1,"confidence_rate":1},{"cnt":[[292,894],[677,894],[677,939],[292,939]],"region":{"top_left_x":292,"top_left_y":893,"width":385,"height":46},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"38d799ba3ff84fc886d3258b0538d964","type":"text","conversion_output":true,"text":"estimate favors CPAP.","text_display":" estimate favors CPAP.","confidence":1,"confidence_rate":1},{"cnt":[[230,988],[1897,988],[1897,1038],[230,1038]],"region":{"top_left_x":229,"top_left_y":988,"width":1669,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"036c2d4197c94dc0a1919d5f64d78dcd","type":"text","conversion_output":true,"text":"- As a result of these considerations, the standard of care at HUP (Appendix 5) has incorporated","text_display":"\n- As a result of these considerations, the standard of care at HUP (Appendix 5) has incorporated","confidence":0.99853515625,"confidence_rate":0.9999854860688677},{"cnt":[[292,1044],[1888,1044],[1888,1098],[292,1098]],"region":{"top_left_x":292,"top_left_y":1044,"width":1597,"height":54},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"495271ea66104d0ea8cd2de298c23922","type":"text","conversion_output":true,"text":"CPAP as the first line in the DR for these very small infants. In synopsis, this adopted the view","text_display":" CPAP as the first line in the DR for these very small infants. In synopsis, this adopted the view","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[292,1104],[1794,1104],[1794,1156],[292,1156]],"region":{"top_left_x":292,"top_left_y":1104,"width":1502,"height":52},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"471ac82cb0bf4055ad058a6fba5991cc","type":"text","conversion_output":true,"text":"that: \"even for infants who eventually require intubation, there is no evidence of harm","text_display":" that: \"even for infants who eventually require intubation, there is no evidence of harm","confidence":0.9990234375,"confidence_rate":0.9999893800602199},{"cnt":[[292,1164],[1188,1164],[1188,1214],[292,1214]],"region":{"top_left_x":292,"top_left_y":1164,"width":897,"height":50},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"69fd8d2b748d4eeea8fa0008968ea4ae","type":"text","conversion_output":true,"text":"associated with starting CPAP in the delivery room.","text_display":" associated with starting CPAP in the delivery room.","confidence":1,"confidence_rate":1},{"cnt":[[168,1259],[1940,1259],[1940,1308],[168,1308]],"region":{"top_left_x":167,"top_left_y":1258,"width":1774,"height":51},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"24541af8d1d34c869d8d536a36ba40d2","type":"text","conversion_output":true,"text":"The approach of using PEEP-CPAP in the DR as an initial means of support has now been widely adopted","text_display":"\n\nThe approach of using PEEP-CPAP in the DR as an initial means of support has now been widely adopted","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[168,1311],[1854,1311],[1854,1364],[168,1364]],"region":{"top_left_x":167,"top_left_y":1310,"width":1688,"height":55},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"45199b8ff45f488f82a1c41fecd05597","type":"text","conversion_output":true,"text":"in the US. \\({ }^{3}\\) It is now considered as the appropriate standard of care in the Hospital of Pennsylvania","text_display":" in the US. \\({ }^{3}\\) It is now considered as the appropriate standard of care in the Hospital of Pennsylvania","confidence":0.9990236759185791,"confidence_rate":0.9999915793372107},{"cnt":[[168,1371],[1828,1371],[1828,1424],[168,1424]],"region":{"top_left_x":167,"top_left_y":1370,"width":1662,"height":55},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d7115ad65bc9486dae03ce3138d25d7d","type":"text","conversion_output":true,"text":"(HUP) NICU, and a recent quality improvement project targeted successful DR-CPAP intervention.","text_display":" (HUP) NICU, and a recent quality improvement project targeted successful DR-CPAP intervention.","confidence":1,"confidence_rate":1},{"cnt":[[168,1467],[1846,1467],[1846,1519],[168,1519]],"region":{"top_left_x":167,"top_left_y":1467,"width":1679,"height":52},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3919fbaa33894ce1884dcb316892c45b","type":"text","conversion_output":true,"text":"Finally to emphasize that our approach does not depart from current standards of care, three very","text_display":"\n\nFinally to emphasize that our approach does not depart from current standards of care, three very","confidence":1,"confidence_rate":1},{"cnt":[[168,1525],[1893,1525],[1893,1577],[168,1577]],"region":{"top_left_x":167,"top_left_y":1525,"width":1726,"height":52},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c59f972a10ce4db5b6e6c2d4b140ec37","type":"text","conversion_output":true,"text":"recent statements of the Committee on Fetus Newborn of the American Academy of Pediatrics (AAP)","text_display":" recent statements of the Committee on Fetus Newborn of the American Academy of Pediatrics (AAP)","confidence":1,"confidence_rate":1},{"cnt":[[168,1586],[346,1586],[346,1635],[168,1635]],"region":{"top_left_x":167,"top_left_y":1585,"width":179,"height":50},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3f81fcd94fbe46b9be1d517d1d10cbc0","type":"text","conversion_output":true,"text":"point out:","text_display":" point out:","confidence":1,"confidence_rate":1},{"cnt":[[232,1650],[1828,1650],[1828,1699],[232,1699]],"region":{"top_left_x":232,"top_left_y":1650,"width":1597,"height":50},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"35408361861244979447fc90d1528532","type":"text","conversion_output":true,"text":"1. Using CPAP immediately after birth with subsequent selective surfactant administration should be","text_display":"\n1. Using CPAP immediately after birth with subsequent selective surfactant administration should be","confidence":1,"confidence_rate":1},{"cnt":[[294,1706],[1923,1706],[1923,1755],[294,1755]],"region":{"top_left_x":294,"top_left_y":1705,"width":1629,"height":51},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7f5ca5d68db549c28e02bbf922c4bf32","type":"text","conversion_output":true,"text":"considered as an alternative to routine intubation with prophylactic or early surfactant administration in","text_display":" considered as an alternative to routine intubation with prophylactic or early surfactant administration in","confidence":1,"confidence_rate":1},{"cnt":[[294,1757],[1162,1757],[1162,1807],[294,1807]],"region":{"top_left_x":294,"top_left_y":1757,"width":869,"height":50},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7b3b5e5815b147838cacba35381d139e","type":"text","conversion_output":true,"text":"preterm infants (Strong Recommendation)(Appendix 6)","text_display":" preterm infants (Strong Recommendation)(Appendix 6)","confidence":0.9731574058532715,"confidence_rate":0.9995142352337882},{"cnt":[[230,1850],[1188,1850],[1188,1899],[230,1899]],"region":{"top_left_x":229,"top_left_y":1849,"width":960,"height":51},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0262c9c01a134fce810880a0c85e4e0e","type":"text","conversion_output":true,"text":"This message is reinforced in another recent statement:","text_display":"\n\nThis message is reinforced in another recent statement:","confidence":1,"confidence_rate":1},{"cnt":[[232,1938],[1934,1938],[1934,1987],[232,1987]],"region":{"top_left_x":232,"top_left_y":1937,"width":1702,"height":51},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"42f260e584814ce69aed48ef722692a9","type":"text","conversion_output":true,"text":"2. Preterm infants treated with early CPAP alone are not at increased risk of adverse outcomes if treatment","text_display":"\n2. Preterm infants treated with early CPAP alone are not at increased risk of adverse outcomes if treatment","confidence":1,"confidence_rate":1},{"cnt":[[294,1994],[1248,1994],[1248,2041],[294,2041]],"region":{"top_left_x":294,"top_left_y":1993,"width":955,"height":49},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"84cdc5ab37464692ab8fb5edb48ee329","type":"text","conversion_output":true,"text":"with surfactant is delayed or not given (Level of Evidence: 1).","text_display":" with surfactant is delayed or not given (Level of Evidence: 1).","confidence":0.9912188034504652,"confidence_rate":0.9998703028458555},{"cnt":[[232,2047],[1841,2047],[1841,2095],[232,2095]],"region":{"top_left_x":232,"top_left_y":2047,"width":1610,"height":48},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4bab24c1bde64175aca25639dfb42aae","type":"text","conversion_output":true,"text":"3. Early initiation of CPAP may lead to a reduction in duration of mechanical ventilation and postnatal","text_display":"\n3. Early initiation of CPAP may lead to a reduction in duration of mechanical ventilation and postnatal","confidence":1,"confidence_rate":1},{"cnt":[[294,2101],[1197,2101],[1197,2151],[294,2151]],"region":{"top_left_x":294,"top_left_y":2101,"width":903,"height":50},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"107dc6bc2bda48c987164cb9c68c91d5","type":"text","conversion_output":true,"text":"corticosteroid therapy (Level of Evidence: 1).(Appendix 7)","text_display":" corticosteroid therapy (Level of Evidence: 1).(Appendix 7)","confidence":0.5734503269195557,"confidence_rate":0.9912121116876832},{"cnt":[[168,2191],[1914,2191],[1914,2237],[168,2237]],"region":{"top_left_x":167,"top_left_y":2191,"width":1748,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"024e691b5637468b85b11f8db0317d98","type":"text","conversion_output":true,"text":"Therefore the use of CPAP in the DR for these infants should be considered a standard of care in North","text_display":"\n\nTherefore the use of CPAP in the DR for these infants should be considered a standard of care in North","confidence":1,"confidence_rate":1},{"cnt":[[168,2247],[1008,2247],[1008,2299],[168,2299]],"region":{"top_left_x":167,"top_left_y":2247,"width":841,"height":52},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"af402b4911ba40088743b92722f90e65","type":"text","conversion_output":true,"text":"America and other developed parts of the world.","text_display":" America and other developed parts of the world.","confidence":1,"confidence_rate":1},{"cnt":[[168,2342],[1923,2342],[1923,2393],[168,2393]],"region":{"top_left_x":167,"top_left_y":2341,"width":1756,"height":53},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"00767f3c7223498fb340b13139442317","type":"text","conversion_output":true,"text":"We propose however, that a new approach to actively recruit lung capacity in the DR would reduce the","text_display":"\n\nWe propose however, that a new approach to actively recruit lung capacity in the DR would reduce the","confidence":1,"confidence_rate":1},{"cnt":[[168,2402],[1884,2402],[1884,2451],[168,2451]],"region":{"top_left_x":167,"top_left_y":2401,"width":1718,"height":51},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"57b2288ddca0489ea9bb15c7e8d86ced","type":"text","conversion_output":true,"text":"need for mechanical ventilation and further decrease morbidity and mortality in the most vulnerable","text_display":" need for mechanical ventilation and further decrease morbidity and mortality in the most vulnerable","confidence":1,"confidence_rate":1},{"cnt":[[168,2460],[1888,2460],[1888,2512],[168,2512]],"region":{"top_left_x":167,"top_left_y":2459,"width":1722,"height":53},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d9eba96903ca4f45a5f8dc8175de3892","type":"text","conversion_output":true,"text":"preterms. 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& \\begin{tabular}{l}\nClinical Coordinating Center (CCC) \\& \\\\\nScientific Leadership \\\\\nPl: Kirpalani \\\\\nCo-PI: Davis, Keszler, \\\\\nAdvisors: Hummler, Lista, tePas\n\\end{tabular} & & \\begin{tabular}{l}\nData Coordinating Center (DCC) \\\\\nBiostatistical Leadership \\\\\nCo-PI: S Ratcliffe \\\\\nResearch Operations \\\\\nClinical Research \\\\\nComputing Unit (CRCU)\n\\end{tabular} & ![](https://cdn.mathpix.com/cropped/0acb697e-f405-4a6e-b315-cce91483f079-14.jpg?height=361\\&width=149\\&top_left_y=356\\&top_left_x=1485) \\\\\n\\hline \\begin{tabular}{l}\nSteering \\\\\nSteering\n\\end{tabular} & \\multicolumn{2}{|c|}{\\multirow[t]{2}{*}{\\begin{tabular}{l}\n21 U.S. and International \\\\\nClinical Research Centers\n\\(\\_\\_\\_\\_\\) \\\\\nSite 11: Elizabeth Foglia, MD \\\\\nHospital of the \\\\\nUniversity of Pennsylvania \\\\\nSite 14: Francis Poulain, MD \\\\\nUniversity of California, Davis \\\\\nDavis, CA \\\\\nPhiladelphia, PA\n\\end{tabular}}} & & 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Katheria, MD \\\\\nSharp Mary Birch Hospital \\\\\nfor Women \\& Newborns \\\\\nSan Diego, CA\n\\end{tabular} & \\begin{tabular}{l}\n\\section*{Site 19: Ursula Guillen, MD \\\\ Site 19: Ursula Guillen, MD} \\\\\n\\section*{Marion Koso-Thomas \\\\ Marion Koso-Thomas \\\\ -}\n\\end{tabular} & \\multirow{4}{*}{\n![](https://cdn.mathpix.com/cropped/0acb697e-f405-4a6e-b315-cce91483f079-14.jpg?height=813\\&width=324\\&top_left_y=1140\\&top_left_x=1630)} \\\\\n\\hline \\begin{tabular}{l}\nEducation \\& \\\\\nCompliance \\\\\nCommittee\n\\end{tabular} & \\multicolumn{3}{|c|}{\\begin{tabular}{l}\nSite 13: Martin Keszler, MD \\\\\nSite 16: Steve M. Donn, MD \\\\\nSite 21: Andrew Hopper, MD \\\\\nWomen \\& Infants Hospital \\\\\nUniversity of Michigan \\\\\nLoma Linda University \\\\\nof Rhodes Island \\\\\nAnn Arbor, Ml \\\\\nLoma Linda, CA \\\\\nProvidence, Rl \\(\\_\\_\\_\\_\\)\n\\end{tabular}} & \\\\\n\\hline Protocol Review Committee & ![](https://cdn.mathpix.com/cropped/0acb697e-f405-4a6e-b315-cce91483f079-14.jpg?height=150\\&width=330\\&top_left_y=1734\\&top_left_x=500) & ![](https://cdn.mathpix.com/cropped/0acb697e-f405-4a6e-b315-cce91483f079-14.jpg?height=150\\&width=400\\&top_left_y=1734\\&top_left_x=820) & \\begin{tabular}{l}\nSite 59: Juin Yee Kong, MD \\\\\nKK Women's and Children's Hospital \\\\\nSingapore\n\\end{tabular} & \\\\\n\\hline & Site 52: Arjan te_Pas, MD & & & \\\\\n\\hline Publication Committee & & & \\begin{tabular}{l}\nSite 60: Helen Liley, MD, ChB, FRACP \\\\\nMater Medical Hospital \\\\\nBrisbane, Australia\n\\end{tabular} & \\\\\n\\hline & & & & \\\\\n\\hline & \\begin{tabular}{l}\nSite 53: Helmut Hummler, MD \\\\\nChildren's Hospital \\\\\nUniversity of Ulm \\\\\nUlm, Germany\n\\end{tabular} & \\begin{tabular}{l}\nSite 57: Burkhard Simma, MD \\\\\nLandeskrankenhaus Feldkirch \\\\\nFeldkirch, Austria\n\\end{tabular} & \\begin{tabular}{l}\nSite 61: Han-Suk Kim, MD, PhD \\\\\nSeoul National University \\\\\nChildren's Hospital \\\\\nSeoul, South Korea\n\\end{tabular} & \\\\\n\\hline & \\begin{tabular}{l}\nSite 54: Gianluca Lista, MD \\\\\nOspedale dei Bambini \\\\\nMilan, Italy\n\\end{tabular} & \\begin{tabular}{l}\nSite 58: Daniel Klotz, MD \\\\\nUniversitätsklinikum Freiburg \\\\\nFreiburg, Germany\n\\end{tabular} & \\begin{tabular}{l}\nSite 62: Won Soon Park, MD, PhD \\\\\nSamsung Medical Center \\\\\nSeoul, South Korea\n\\end{tabular} & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|}\n\\hline & \\begin{tabular}{l}\nClinical Coordinating Center (CCC) \\& \\\\\nScientific Leadership \\\\\nPl: Kirpalani \\\\\nCo-PI: Davis, Keszler, \\\\\nAdvisors: Hummler, Lista, tePas\n\\end{tabular} & & \\begin{tabular}{l}\nData Coordinating Center (DCC) \\\\\nBiostatistical Leadership \\\\\nCo-PI: S Ratcliffe \\\\\nResearch Operations \\\\\nClinical Research \\\\\nComputing Unit (CRCU)\n\\end{tabular} & ![](https://cdn.mathpix.com/cropped/0acb697e-f405-4a6e-b315-cce91483f079-14.jpg?height=361\\&width=149\\&top_left_y=356\\&top_left_x=1485) \\\\\n\\hline \\begin{tabular}{l}\nSteering \\\\\nSteering\n\\end{tabular} & \\multicolumn{2}{|c|}{\\multirow[t]{2}{*}{\\begin{tabular}{l}\n21 U.S. and International \\\\\nClinical Research Centers\n\\(\\_\\_\\_\\_\\) \\\\\nSite 11: Elizabeth Foglia, MD \\\\\nHospital of the \\\\\nUniversity of Pennsylvania \\\\\nSite 14: Francis Poulain, MD \\\\\nUniversity of California, Davis \\\\\nDavis, CA \\\\\nPhiladelphia, PA\n\\end{tabular}}} & & \\begin{tabular}{l}\n![](https://cdn.mathpix.com/cropped/0acb697e-f405-4a6e-b315-cce91483f079-14.jpg?height=138\\&width=314\\&top_left_y=859\\&top_left_x=1617\\&polygon=128,0,312,17,314,19,314,104,312,128,304,132,169,138,117,138,48,132,13,128,5,123,3,119,0,102,0,19,5,15,126,0) \\\\\nProgram Scientist: \\\\\nProgram Scientist:\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\nCommittee \\\\\nChair: H Kirpalani\n\\end{tabular} & \\begin{tabular}{l}\nSite 12: Soraya Abbasi, MD \\\\\nPennsylvania Hospital \\\\\nPhiladelphia, PA\n\\end{tabular} & \\begin{tabular}{l}\nSite 15: Anup C. 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These are fully described in Section 8, ‘Research Ethics’.","text_display":" antenatal consent procedure has been adopted. These are fully described in Section 8, ‘Research Ethics’.","confidence":0.998046875,"confidence_rate":0.9999820640614399},{"cnt":[[163,1347],[537,1347],[537,1414],[163,1414]],"region":{"top_left_x":163,"top_left_y":1347,"width":375,"height":67},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47d418b84bf4431f97793b176740296b","type":"section_header","conversion_output":false,"children_ids":["c209a284081e4bf7aca03ae081ab0d96"],"text":"","text_display":""},{"cnt":[[168,1354],[531,1354],[531,1407],[168,1407]],"region":{"top_left_x":167,"top_left_y":1353,"width":364,"height":55},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c209a284081e4bf7aca03ae081ab0d96","type":"text","conversion_output":true,"parent_id":"47d418b84bf4431f97793b176740296b","text":"4.3. 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This blinded 36 week PMA","text_display":" at 36 weeks, neurodevelopment and an objective outcome of death. This blinded 36 week PMA","confidence":1,"confidence_rate":1},{"cnt":[[168,1914],[1904,1914],[1904,1966],[168,1966]],"region":{"top_left_x":167,"top_left_y":1914,"width":1737,"height":52},"line":60,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d243937f54248d688d63e4f85e64d23","type":"text","conversion_output":true,"text":"assessment will be performed by clinicians (nurses, RTs, physicians) who did not look after that infant.","text_display":" assessment will be performed by clinicians (nurses, RTs, physicians) who did not look after that infant.","confidence":1,"confidence_rate":1},{"cnt":[[168,1972],[1944,1972],[1944,2020],[168,2020]],"region":{"top_left_x":167,"top_left_y":1972,"width":1778,"height":48},"line":61,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fd54c4212c6c43f2a4d0c05c39e540da","type":"text","conversion_output":true,"text":"Parents will not be blinded to the intervention and will be informed of the allocation after the infant has","text_display":" Parents will not be blinded to the intervention and will be informed of the allocation after the infant has","confidence":1,"confidence_rate":1},{"cnt":[[168,2032],[952,2032],[952,2078],[168,2078]],"region":{"top_left_x":167,"top_left_y":2032,"width":785,"height":46},"line":62,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e991a0b2c4fa41acae828713e6c99d2d","type":"text","conversion_output":true,"text":"been admitted to the neonatal intensive unit.","text_display":" been admitted to the neonatal intensive unit.","confidence":1,"confidence_rate":1},{"cnt":[[163,2118],[617,2118],[617,2181],[163,2181]],"region":{"top_left_x":163,"top_left_y":2118,"width":454,"height":63},"line":63,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d747b82345ed4921bbc1871da6147add","type":"section_header","conversion_output":false,"children_ids":["bc571141e5e6424ba2bf2fc96cefd553"],"text":"","text_display":""},{"cnt":[[168,2123],[608,2123],[608,2176],[168,2176]],"region":{"top_left_x":167,"top_left_y":2122,"width":442,"height":55},"line":64,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc571141e5e6424ba2bf2fc96cefd553","type":"text","conversion_output":true,"parent_id":"d747b82345ed4921bbc1871da6147add","text":"4.4. 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The decision making process in","confidence":1,"confidence_rate":1},{"cnt":[[232,236],[1880,236],[1880,286],[232,286]],"region":{"top_left_x":232,"top_left_y":236,"width":1648,"height":50},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5fc7e5db75a24466a98a18e4b5eb8403","type":"text","conversion_output":true,"text":"determining if an infant is eligible is to be done simultaneously while performing the initial steps,","text_display":" determining if an infant is eligible is to be done simultaneously while performing the initial steps,","confidence":1,"confidence_rate":1},{"cnt":[[232,296],[376,296],[376,337],[232,337]],"region":{"top_left_x":232,"top_left_y":296,"width":144,"height":42},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"81d7d9b0d0a4488899611aa43ad638c4","type":"text","conversion_output":true,"text":"such as:","text_display":" such as:","confidence":1,"confidence_rate":1},{"cnt":[[296,389],[1137,389],[1137,436],[296,436]],"region":{"top_left_x":296,"top_left_y":388,"width":841,"height":49},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5f1df9ed9b7b470fbd0415bac279a7e0","type":"text","conversion_output":true,"text":"1) Placing the infant on the resuscitation trolley;","text_display":"\n1) Placing the infant on the resuscitation trolley;","confidence":0.99951171875,"confidence_rate":0.9999912786005654},{"cnt":[[296,449],[1257,449],[1257,496],[296,496]],"region":{"top_left_x":296,"top_left_y":449,"width":961,"height":48},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f14d8819ed9b4acc8124fd4c36a337a6","type":"text","conversion_output":true,"text":"2) Suction airway, open airway and proceed with CPAP;","text_display":"\n2) Suction airway, open airway and proceed with CPAP;","confidence":1,"confidence_rate":1},{"cnt":[[296,507],[1487,507],[1487,552],[296,552]],"region":{"top_left_x":296,"top_left_y":507,"width":1191,"height":46},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a9b0629006a04372a6c283198478dc69","type":"text","conversion_output":true,"text":"3) Wrap the infant in saran wrap/neo wrap for temperature stability;","text_display":"\n3) Wrap the infant in saran wrap/neo wrap for temperature stability;","confidence":1,"confidence_rate":1},{"cnt":[[296,567],[1257,567],[1257,612],[296,612]],"region":{"top_left_x":296,"top_left_y":567,"width":961,"height":46},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01b752f546ab4b25933e57c35886245b","type":"text","conversion_output":true,"text":"4) Assessment of heart rate and respiratory effort ; and","text_display":"\n4) Assessment of heart rate and respiratory effort ; and","confidence":0.99951171875,"confidence_rate":0.9999919934665097},{"cnt":[[296,623],[1038,623],[1038,672],[296,672]],"region":{"top_left_x":296,"top_left_y":623,"width":742,"height":50},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c240209b99c54e709ac3a0cee52c1b84","type":"text","conversion_output":true,"text":"5) Placement of the pulse oximeter probe.","text_display":"\n5) Placement of the pulse oximeter probe.","confidence":1,"confidence_rate":1},{"cnt":[[232,718],[1931,718],[1931,763],[232,763]],"region":{"top_left_x":232,"top_left_y":717,"width":1700,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e13b86cc329d42829a762351e7f837b2","type":"text","conversion_output":true,"text":"All 5 initial steps take place at the same time by various members of the DR team. 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Randomly permutated blocks","text_display":" assure close to equal numbers of subjects in each treatment group. Randomly permutated blocks","confidence":1,"confidence_rate":1},{"cnt":[[232,623],[1876,623],[1876,672],[232,672]],"region":{"top_left_x":232,"top_left_y":623,"width":1644,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd42e6089c864c24ad8d57d6f7ac8faf","type":"text","conversion_output":true,"text":"with unequal blocks of varying sizes, and allocation ratio within each block of 1 , will be used. The","text_display":" with unequal blocks of varying sizes, and allocation ratio within each block of 1 , will be used. 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Stratifying on any more variables (such as gender) is not","text_display":" 23 \\& 24 weeks versus 25 \\& 26 weeks). Stratifying on any more variables (such as gender) is not","confidence":1,"confidence_rate":1},{"cnt":[[232,950],[1893,950],[1893,999],[232,999]],"region":{"top_left_x":232,"top_left_y":949,"width":1661,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2e7417644544efb93e306b03161a977","type":"text","conversion_output":true,"text":"feasible with the potentially small enrollment numbers expected at some sites. We will perform a","text_display":" feasible with the potentially small enrollment numbers expected at some sites. We will perform a","confidence":0.931640625,"confidence_rate":0.9992991750574384},{"cnt":[[232,1008],[1706,1008],[1706,1059],[232,1059]],"region":{"top_left_x":232,"top_left_y":1007,"width":1474,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ac3d0e4ab4a46929c5ac7da19e77a0e","type":"text","conversion_output":true,"text":"planned adjustment following the end of the trial to adjust for gender. Use of separate","text_display":" planned adjustment following the end of the trial to adjust for gender. Use of separate","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[232,1066],[1884,1066],[1884,1115],[232,1115]],"region":{"top_left_x":232,"top_left_y":1065,"width":1653,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e72dc24fa8634e57a8cd58a246f0a7f5","type":"text","conversion_output":true,"text":"randomization schedules by site (ie stratified by centre, with each site having the same allocation","text_display":" randomization schedules by site (ie stratified by centre, with each site having the same allocation","confidence":1,"confidence_rate":1},{"cnt":[[232,1126],[1936,1126],[1936,1175],[232,1175]],"region":{"top_left_x":232,"top_left_y":1125,"width":1704,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f1820da56a34746b8306c8bdcac8dd5","type":"text","conversion_output":true,"text":"ratio of treatment groups) ensures comparability of the treatment groups with regard to the patient","text_display":" ratio of treatment groups) ensures comparability of the treatment groups with regard to the patient","confidence":1,"confidence_rate":1},{"cnt":[[232,1182],[1901,1182],[1901,1231],[232,1231]],"region":{"top_left_x":232,"top_left_y":1181,"width":1670,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9dfc1ddbff34420b00c768b1f8fe39e","type":"text","conversion_output":true,"text":"mix coming from the various sites in the trial. This assurance is important because the populations","text_display":" mix coming from the various sites in the trial. This assurance is important because the populations","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[232,1242],[1901,1242],[1901,1291],[232,1291]],"region":{"top_left_x":232,"top_left_y":1241,"width":1670,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eccf8c79198b4656910cac5270c5b79a","type":"text","conversion_output":true,"text":"can differ widely with regard to subject characteristics. Further, there may be subtle differences in","text_display":" can differ widely with regard to subject characteristics. Further, there may be subtle differences in","confidence":1,"confidence_rate":1},{"cnt":[[232,1302],[1871,1302],[1871,1351],[232,1351]],"region":{"top_left_x":232,"top_left_y":1301,"width":1640,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83f164c2cae446ff84e73f9d63aef069","type":"text","conversion_output":true,"text":"the standard of care from site to site, despite the fact that this study has a well-defined plan and","text_display":" the standard of care from site to site, despite the fact that this study has a well-defined plan and","confidence":1,"confidence_rate":1},{"cnt":[[232,1360],[1910,1360],[1910,1407],[232,1407]],"region":{"top_left_x":232,"top_left_y":1359,"width":1678,"height":49},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ef4200562764da69625a44f7c90d9ed","type":"text","conversion_output":true,"text":"strict inclusion and exclusion criteria. Finally, stratification by gestational age is needed, as it is well","text_display":" strict inclusion and exclusion criteria. Finally, stratification by gestational age is needed, as it is well","confidence":0.99951171875,"confidence_rate":0.9999956778810385},{"cnt":[[232,1418],[1459,1418],[1459,1467],[232,1467]],"region":{"top_left_x":232,"top_left_y":1417,"width":1227,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"991fda90997d44979217a2658bdf8ecb","type":"text","conversion_output":true,"text":"know that mortality outcomes improve as the gestational age increases.","text_display":" know that mortality outcomes improve as the gestational age increases.","confidence":1,"confidence_rate":1},{"cnt":[[232,1512],[1781,1512],[1781,1560],[232,1560]],"region":{"top_left_x":232,"top_left_y":1512,"width":1550,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64a229699ff841acb20d10d585a1cd4e","type":"text","conversion_output":true,"text":"While there are clearly subject-specific variables that will be observed and recorded before","text_display":"\n\nWhile there are clearly subject-specific variables that will be observed and recorded before","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[232,1568],[1929,1568],[1929,1618],[232,1618]],"region":{"top_left_x":232,"top_left_y":1568,"width":1698,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd25ec8b19d94d9ba3832178e0f946ad","type":"text","conversion_output":true,"text":"randomization that could be used for stratification, such as gender, there are a number of problems","text_display":" randomization that could be used for stratification, such as gender, there are a number of problems","confidence":1,"confidence_rate":1},{"cnt":[[232,1629],[1863,1629],[1863,1678],[232,1678]],"region":{"top_left_x":232,"top_left_y":1628,"width":1631,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ccfa17214d8944c6a233c7fe8808a337","type":"text","conversion_output":true,"text":"with including more stratification variables. Of most concern, stratification by multiple variables","text_display":" with including more stratification variables. Of most concern, stratification by multiple variables","confidence":1,"confidence_rate":1},{"cnt":[[232,1687],[1824,1687],[1824,1738],[232,1738]],"region":{"top_left_x":232,"top_left_y":1686,"width":1593,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2fa3c9424f404f06a819c8b7a90c5fd5","type":"text","conversion_output":true,"text":"would likely result in small numbers per group and a fairly large chance of departure from the","text_display":" would likely result in small numbers per group and a fairly large chance of departure from the","confidence":1,"confidence_rate":1},{"cnt":[[232,1745],[1858,1745],[1858,1794],[232,1794]],"region":{"top_left_x":232,"top_left_y":1744,"width":1627,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6117f87beae04f3e9ec1688ee7271fe0","type":"text","conversion_output":true,"text":"desired allocation ratio. Since we are proposing a study with 300 subjects per group, the groups","text_display":" desired allocation ratio. Since we are proposing a study with 300 subjects per group, the groups","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[232,1800],[1906,1800],[1906,1852],[232,1852]],"region":{"top_left_x":232,"top_left_y":1800,"width":1674,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"195b110fc8bd4602bb6f9adf2cb1e6ef","type":"text","conversion_output":true,"text":"should be large enough that stratification should not be necessary to assure that the two arms will","text_display":" should be large enough that stratification should not be necessary to assure that the two arms will","confidence":1,"confidence_rate":1},{"cnt":[[232,1861],[1884,1861],[1884,1910],[232,1910]],"region":{"top_left_x":232,"top_left_y":1860,"width":1653,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eff9222502714168a9cfad1515e75c76","type":"text","conversion_output":true,"text":"have approximately equal representation of the major confounding variables. However, a careful","text_display":" have approximately equal representation of the major confounding variables. However, a careful","confidence":1,"confidence_rate":1},{"cnt":[[232,1921],[1803,1921],[1803,1970],[232,1970]],"region":{"top_left_x":232,"top_left_y":1920,"width":1571,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e90d9fbe9245413f9bea19d3e70a2be8","type":"text","conversion_output":true,"text":"post-hoc analysis will be carried out to assure that the allocation was, in fact, equal. Analysis","text_display":" post-hoc analysis will be carried out to assure that the allocation was, in fact, equal. Analysis","confidence":1,"confidence_rate":1},{"cnt":[[232,1979],[1824,1979],[1824,2030],[232,2030]],"region":{"top_left_x":232,"top_left_y":1978,"width":1593,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf3af59f4f9f46e9821fd37a2717dc69","type":"text","conversion_output":true,"text":"procedures involving post-stratification, and multiple regression will be used to adjust for any","text_display":" procedures involving post-stratification, and multiple regression will be used to adjust for any","confidence":1,"confidence_rate":1},{"cnt":[[232,2037],[698,2037],[698,2086],[232,2086]],"region":{"top_left_x":232,"top_left_y":2036,"width":467,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"970c4db20a8e405993c7c79858365d50","type":"text","conversion_output":true,"text":"baseline group differences.","text_display":" baseline group differences.","confidence":1,"confidence_rate":1},{"cnt":[[163,2125],[1089,2125],[1089,2185],[163,2185]],"region":{"top_left_x":163,"top_left_y":2124,"width":927,"height":61},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8980f4a41bf4fe388be9a5ee9b0b97e","type":"section_header","conversion_output":false,"children_ids":["af64fb2496d046d883fd1370a0395629"],"text":"","text_display":""},{"cnt":[[168,2131],[1085,2131],[1085,2181],[168,2181]],"region":{"top_left_x":167,"top_left_y":2131,"width":918,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af64fb2496d046d883fd1370a0395629","type":"text","conversion_output":true,"parent_id":"f8980f4a41bf4fe388be9a5ee9b0b97e","text":"4.5. Intervention Maneuvers in Delivery Room","text_display":"\n\n\\subsection*{4.5. Intervention Maneuvers in Delivery Room}","confidence":1,"confidence_rate":1},{"cnt":[[172,2202],[1880,2202],[1880,2249],[172,2249]],"region":{"top_left_x":171,"top_left_y":2202,"width":1709,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6937437d34d43069d21f989686aed7a","type":"text","conversion_output":true,"text":"Because this is an international multi-site trial, we are aware that International sites may have minor","text_display":"\n\nBecause this is an international multi-site trial, we are aware that International sites may have minor","confidence":1,"confidence_rate":1},{"cnt":[[172,2260],[1893,2260],[1893,2310],[172,2310]],"region":{"top_left_x":171,"top_left_y":2260,"width":1722,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cda8a6e4b9f4358a74dd72116b2b416","type":"text","conversion_output":true,"text":"modifications of the below, all of which will be assessed for trial approval by the Steering Committee.","text_display":" modifications of the below, all of which will be assessed for trial approval by the Steering Committee.","confidence":1,"confidence_rate":1},{"cnt":[[172,2316],[1919,2316],[1919,2365],[172,2365]],"region":{"top_left_x":171,"top_left_y":2316,"width":1748,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"da99918efd0143e7a965c64e8edada65","type":"text","conversion_output":true,"text":"However we do make reference below to \"site clinical local practices\". If such minor variations in these","text_display":" However we do make reference below to \"site clinical local practices\". If such minor variations in these","confidence":0.99951171875,"confidence_rate":0.9999955192715237},{"cnt":[[168,2376],[1379,2376],[1379,2426],[168,2426]],"region":{"top_left_x":167,"top_left_y":2376,"width":1213,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"84a61b2326ea4723b180b46d5a76777d","type":"text","conversion_output":true,"text":"will not affect the validity and integrity of the tral, they will be allowed.","text_display":" will not affect the validity and integrity of the tral, they will be allowed.","confidence":1,"confidence_rate":1},{"cnt":[[170,2471],[1936,2471],[1936,2520],[170,2520]],"region":{"top_left_x":169,"top_left_y":2470,"width":1767,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d06388c3b287486e80879d695f835db5","type":"text","conversion_output":true,"text":"At all sites where antenatal consent has been obtained, or in some sites where the local IRB has granted","text_display":"\n\nAt all sites where antenatal consent has been obtained, or in some sites where the local IRB has granted","confidence":1,"confidence_rate":1},{"cnt":[[168,2520],[1934,2520],[1934,2576],[168,2576]],"region":{"top_left_x":167,"top_left_y":2520,"width":1767,"height":56},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73da1f87fd484b38827144cd7507d28e","type":"text","conversion_output":true,"text":"waiver, eligible infants \\(\\left(23^{0}-26^{6}\\right.\\) completed weeks GA) will be taken to a resuscitation trolley, placed in a","text_display":" waiver, eligible infants \\(\\left(23^{0}-26^{6}\\right.\\) completed weeks GA) will be taken to a resuscitation trolley, placed in a","confidence":0.9576571670902746,"confidence_rate":0.9996646653207955},{"cnt":[[1904,2643],[1955,2643],[1955,2696],[1904,2696]],"region":{"top_left_x":1903,"top_left_y":2642,"width":53,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ddfeae4d55c41cfad94a039de299a52","type":"page_info","conversion_output":false,"text":"18","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-19","page":19,"lines":[{"cnt":[[168,60],[1222,60],[1222,116],[168,116]],"region":{"top_left_x":167,"top_left_y":60,"width":1056,"height":57},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4cea7151131a404aa995f6c486a80706","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) Study","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1491,62],[1916,62],[1916,114],[1491,114]],"region":{"top_left_x":1491,"top_left_y":62,"width":426,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"002f2f4d29834c47865c9a71e8f3b3e6","type":"page_info","conversion_output":false,"text":"Version 2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[168,168],[1906,168],[1906,230],[168,230]],"region":{"top_left_x":167,"top_left_y":167,"width":1739,"height":63},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8d9f69f85614afdab59c0a2672a035e","type":"text","conversion_output":true,"text":"plastic wrap and have a \\(SpO _{2}\\) probe attached to the right hand (NRP p.54). \\({ }^{4}\\) The infant's airway will be","text_display":"\nplastic wrap and have a \\(SpO _{2}\\) probe attached to the right hand (NRP p.54). \\({ }^{4}\\) The infant's airway will be","confidence":0.9960978019516915,"confidence_rate":0.9999701544034977},{"cnt":[[168,232],[1953,232],[1953,288],[168,288]],"region":{"top_left_x":167,"top_left_y":232,"width":1786,"height":56},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"748862bc3a9940f2a537e7f7153d5a14","type":"text","conversion_output":true,"text":"cleared and the infant will be commenced on mask or nasal prong CPAP at \\(5-7 cm H _{2} O\\) and \\(FiO _{2} 0.3\\) via a","text_display":" cleared and the infant will be commenced on mask or nasal prong CPAP at \\(5-7 cm H _{2} O\\) and \\(FiO _{2} 0.3\\) via a","confidence":0.8701803684234619,"confidence_rate":0.9989550217929886},{"cnt":[[168,296],[316,296],[316,346],[168,346]],"region":{"top_left_x":167,"top_left_y":296,"width":149,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"234b0d03b5ef487f931ce842af531cca","type":"text","conversion_output":true,"text":"T-piece.","text_display":" T-piece.","confidence":1,"confidence_rate":1},{"cnt":[[165,387],[1931,387],[1931,440],[165,440]],"region":{"top_left_x":165,"top_left_y":386,"width":1767,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee967c42125447889e3a551963c6895e","type":"text","conversion_output":true,"text":"A wide range of authorities have now accepted this in the peer-reviewed press as a standard procedure","text_display":"\n\nA wide range of authorities have now accepted this in the peer-reviewed press as a standard procedure","confidence":1,"confidence_rate":1},{"cnt":[[168,447],[1914,447],[1914,501],[168,501]],"region":{"top_left_x":167,"top_left_y":446,"width":1748,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1dd97940123943da8fd13af133bf745f","type":"text","conversion_output":true,"text":"in 2013-2014. We have ensured that we are fully compliant with ILCOR 2010 and NRP 2011 standards,","text_display":" in 2013-2014. We have ensured that we are fully compliant with ILCOR 2010 and NRP 2011 standards,","confidence":1,"confidence_rate":1},{"cnt":[[168,505],[1929,505],[1929,556],[168,556]],"region":{"top_left_x":167,"top_left_y":504,"width":1763,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f45a395f12134ae9a0cc92c9057e1c2a","type":"text","conversion_output":true,"text":"using CPAP or PEEP. We have discussed aspects of this in the study background section, and referenced","text_display":" using CPAP or PEEP. We have discussed aspects of this in the study background section, and referenced","confidence":1,"confidence_rate":1},{"cnt":[[168,554],[1798,554],[1798,614],[168,614]],"region":{"top_left_x":167,"top_left_y":554,"width":1632,"height":61},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d4ff79b36d24a8daf0e5b4c58a71c85","type":"text","conversion_output":true,"text":"the January published latest statements from the Fetus and Newborn Committee of the AAP. \\({ }^{5,6}\\)","text_display":" the January published latest statements from the Fetus and Newborn Committee of the AAP. \\({ }^{5,6}\\)","confidence":0.9965853681787848,"confidence_rate":0.9999667920564276},{"cnt":[[168,619],[1953,619],[1953,675],[168,675]],"region":{"top_left_x":167,"top_left_y":618,"width":1786,"height":57},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"58d48abf668a48ada0322353656604e0","type":"text","conversion_output":true,"text":"(Appendix 7) Our NRP compliant approach is attested to in several other ways, including the approval of","text_display":" (Appendix 7) Our NRP compliant approach is attested to in several other ways, including the approval of","confidence":1,"confidence_rate":1},{"cnt":[[168,679],[1953,679],[1953,733],[168,733]],"region":{"top_left_x":167,"top_left_y":678,"width":1786,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f6e58c8543044548295e9140995a9f5","type":"text","conversion_output":true,"text":"the DSMB that includes Dr. Kattwinkel (one of the co-founders of the AAP NRP program); the inclusion in","text_display":" the DSMB that includes Dr. Kattwinkel (one of the co-founders of the AAP NRP program); the inclusion in","confidence":1,"confidence_rate":1},{"cnt":[[168,739],[1899,739],[1899,793],[168,793]],"region":{"top_left_x":167,"top_left_y":739,"width":1733,"height":54},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af5917d8d2e443ac892b3fdf699e0bb5","type":"text","conversion_output":true,"text":"our group of a NRP committee member (Dr. Ades from CHOP-HUP); and consistency with the Quality","text_display":" our group of a NRP committee member (Dr. Ades from CHOP-HUP); and consistency with the Quality","confidence":1,"confidence_rate":1},{"cnt":[[168,797],[1936,797],[1936,849],[168,849]],"region":{"top_left_x":167,"top_left_y":797,"width":1769,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c5da0758120847b09b51f5537201058e","type":"text","conversion_output":true,"text":"Program initiatives of the DR processes in HUP. (Appendix 8).For the trial, the time of birth has been set","text_display":" Program initiatives of the DR processes in HUP. (Appendix 8).For the trial, the time of birth has been set","confidence":0.9990236759185791,"confidence_rate":0.9999912000297451},{"cnt":[[168,855],[1906,855],[1906,909],[168,909]],"region":{"top_left_x":167,"top_left_y":855,"width":1739,"height":54},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a26886e84844abc9c32206612960149","type":"text","conversion_output":true,"text":"as final emergence of the infant from delivery. The time of cord clamping will be recorded. Finally, the","text_display":" as final emergence of the infant from delivery. The time of cord clamping will be recorded. Finally, the","confidence":1,"confidence_rate":1},{"cnt":[[168,915],[1854,915],[1854,969],[168,969]],"region":{"top_left_x":167,"top_left_y":915,"width":1688,"height":54},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2722eb3316be4211bf66d4b23c49eaf8","type":"text","conversion_output":true,"text":"time for the Study Intervention (see Figure 1 below) is measured from the point of the infant being","text_display":" time for the Study Intervention (see Figure 1 below) is measured from the point of the infant being","confidence":0.99853515625,"confidence_rate":0.9999862999285899},{"cnt":[[168,971],[1147,971],[1147,1025],[168,1025]],"region":{"top_left_x":167,"top_left_y":971,"width":981,"height":54},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae3ac5d5018d4d778881e3ec516814aa","type":"text","conversion_output":true,"text":"placed on the resuscitation trolley (defined as time zero).","text_display":" placed on the resuscitation trolley (defined as time zero).","confidence":0.99951171875,"confidence_rate":0.999992368771335},{"cnt":[[168,1066],[1940,1066],[1940,1119],[168,1119]],"region":{"top_left_x":167,"top_left_y":1065,"width":1774,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d42aa38547445d7b995e0c189c7d087","type":"text","conversion_output":true,"text":"Thereafter, an infant with inadequate respiration defined as gasping or apneic; or is bradycardic defined","text_display":"\n\nThereafter, an infant with inadequate respiration defined as gasping or apneic; or is bradycardic defined","confidence":1,"confidence_rate":1},{"cnt":[[168,1124],[1953,1124],[1953,1177],[168,1177]],"region":{"top_left_x":167,"top_left_y":1123,"width":1786,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3accd25a4434498ebb8f9ed42a4849f3","type":"text","conversion_output":true,"text":"as \\(HR <100 bpm\\) and not rising (as labelled in the algorithm diagram: Figure 1) will be eligible for the SAIL","text_display":" as \\(HR <100 bpm\\) and not rising (as labelled in the algorithm diagram: Figure 1) will be eligible for the SAIL","confidence":0.9888010025024414,"confidence_rate":0.9999061529170665},{"cnt":[[168,1182],[1940,1182],[1940,1235],[168,1235]],"region":{"top_left_x":167,"top_left_y":1181,"width":1774,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d011fc9aaa4746b5b783011be7958e61","type":"text","conversion_output":true,"text":"trial. Time in which to determine eligibility is 30 seconds, however an infant can declare himself/herself","text_display":" trial. Time in which to determine eligibility is 30 seconds, however an infant can declare himself/herself","confidence":1,"confidence_rate":1},{"cnt":[[168,1242],[1369,1242],[1369,1293],[168,1293]],"region":{"top_left_x":167,"top_left_y":1241,"width":1202,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2597ebc184a483ebb6aa48fbceaed98","type":"text","conversion_output":true,"text":"in less time. The initial 30 seconds are congruent with NRP guidelines.","text_display":" in less time. The initial 30 seconds are congruent with NRP guidelines.","confidence":1,"confidence_rate":1},{"cnt":[[168,1387],[168,1332],[1863,1334],[1863,1389]],"region":{"top_left_x":167,"top_left_y":1331,"width":1696,"height":59},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ddaaf22e7e4543a1b5367d4f462be047","type":"text","conversion_output":true,"text":"Infants who are not eligible for the SAIL trial will be continued on CPAP, and all further resuscitative","text_display":"\n\nInfants who are not eligible for the SAIL trial will be continued on CPAP, and all further resuscitative","confidence":1,"confidence_rate":1},{"cnt":[[168,1392],[1179,1392],[1179,1446],[168,1446]],"region":{"top_left_x":167,"top_left_y":1392,"width":1013,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f24b2656cc2b4b1394f69114200f9307","type":"text","conversion_output":true,"text":"measures will be made according to local clinical protocols.","text_display":" measures will be made according to local clinical protocols.","confidence":1,"confidence_rate":1},{"cnt":[[168,1487],[1830,1487],[1830,1540],[168,1540]],"region":{"top_left_x":167,"top_left_y":1486,"width":1664,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10e9b5f25f4f4e1a939c38018794062b","type":"text","conversion_output":true,"text":"For infants who are eligible for the SAIL trial, the randomization envelope will be opened, and the","text_display":"\n\nFor infants who are eligible for the SAIL trial, the randomization envelope will be opened, and the","confidence":1,"confidence_rate":1},{"cnt":[[168,1543],[1914,1543],[1914,1596],[168,1596]],"region":{"top_left_x":167,"top_left_y":1542,"width":1748,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f794f8b385d54e138dd1fb252862bf64","type":"text","conversion_output":true,"text":"treatment allocation will be announced to the clinical team. Thereafter, the protocol algorithm will be","text_display":" treatment allocation will be announced to the clinical team. Thereafter, the protocol algorithm will be","confidence":1,"confidence_rate":1},{"cnt":[[168,1603],[1854,1603],[1854,1652],[168,1652]],"region":{"top_left_x":167,"top_left_y":1602,"width":1688,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"308a6320e6ca428ab60bc45eaff29512","type":"text","conversion_output":true,"text":"followed for babies who are randomized to the SI intervention. Infants who are randomized to the","text_display":" followed for babies who are randomized to the SI intervention. Infants who are randomized to the","confidence":0.5859060287475586,"confidence_rate":0.9947209550479598},{"cnt":[[168,1661],[1936,1661],[1936,1712],[168,1712]],"region":{"top_left_x":167,"top_left_y":1660,"width":1769,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"182fecd049a4436dace87ff9bc4f7915","type":"text","conversion_output":true,"text":"control arm will be treated according to local clinical protocols. (See 4.5.1 for more detail on the control","text_display":" control arm will be treated according to local clinical protocols. (See 4.5.1 for more detail on the control","confidence":1,"confidence_rate":1},{"cnt":[[168,1721],[397,1721],[397,1772],[168,1772]],"region":{"top_left_x":167,"top_left_y":1720,"width":231,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a85a1ffa9e4044ec805467ec9f888c82","type":"text","conversion_output":true,"text":"arm infants).","text_display":" arm infants).","confidence":1,"confidence_rate":1},{"cnt":[[168,1813],[1768,1813],[1768,1867],[168,1867]],"region":{"top_left_x":167,"top_left_y":1813,"width":1602,"height":54},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c98fa731df1f4863891dd31e96365ede","type":"text","conversion_output":true,"text":"Regarding choice of pressures: \"The primary measure of adequate initial ventilation is prompt","text_display":"\n\nRegarding choice of pressures: \"The primary measure of adequate initial ventilation is prompt","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[168,1873],[1953,1873],[1953,1927],[168,1927]],"region":{"top_left_x":167,"top_left_y":1873,"width":1786,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f4a0d4e17344918b96ca660605f136a","type":"text","conversion_output":true,"text":"improvement in heart rate. Chest wall movement should be assessed if heart rate does not improve. The","text_display":" improvement in heart rate. Chest wall movement should be assessed if heart rate does not improve. The","confidence":1,"confidence_rate":1},{"cnt":[[168,1929],[1886,1929],[1886,1983],[168,1983]],"region":{"top_left_x":167,"top_left_y":1929,"width":1720,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4703cdace55245c1a082a519ebd27234","type":"text","conversion_output":true,"text":"initial peak inflating pressures needed are variable and unpredictable and should be individualized to","text_display":" initial peak inflating pressures needed are variable and unpredictable and should be individualized to","confidence":1,"confidence_rate":1},{"cnt":[[168,1988],[1919,1986],[1919,2039],[168,2041]],"region":{"top_left_x":167,"top_left_y":1985,"width":1752,"height":57},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c417e3652fb4dd7a57c286f3b290b19","type":"text","conversion_output":true,"text":"achieve an increase in heart rate or movement of the chest with each breath. Inflation pressure should","text_display":" achieve an increase in heart rate or movement of the chest with each breath. Inflation pressure should","confidence":1,"confidence_rate":1},{"cnt":[[168,2047],[1914,2047],[1914,2099],[168,2099]],"region":{"top_left_x":167,"top_left_y":2047,"width":1748,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2c2aecc44f04d1d8b7f7b0cda99d261","type":"text","conversion_output":true,"text":"be monitored; an initial inflation pressure of \\(20 cm H _{2} O\\) may be effective, but 30 to \\(40 cm H _{2} O\\) may be","text_display":" be monitored; an initial inflation pressure of \\(20 cm H _{2} O\\) may be effective, but 30 to \\(40 cm H _{2} O\\) may be","confidence":0.9892628192901611,"confidence_rate":0.9999223394171384},{"cnt":[[168,2105],[1863,2105],[1863,2159],[168,2159]],"region":{"top_left_x":167,"top_left_y":2105,"width":1696,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e007bf34ffd42eaab3b586cfc57df24","type":"text","conversion_output":true,"text":"required in some term babies without spontaneous ventilation if circumstances preclude the use of","text_display":" required in some term babies without spontaneous ventilation if circumstances preclude the use of","confidence":1,"confidence_rate":1},{"cnt":[[168,2166],[1846,2166],[1846,2219],[168,2219]],"region":{"top_left_x":167,"top_left_y":2165,"width":1679,"height":55},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48f0aa2fe49c4379b8432ea814d3d511","type":"text","conversion_output":true,"text":"pressure monitoring, the minimal inflation required to achieve an increase in heart rate should be","text_display":" pressure monitoring, the minimal inflation required to achieve an increase in heart rate should be","confidence":1,"confidence_rate":1},{"cnt":[[168,2221],[1497,2221],[1497,2275],[168,2275]],"region":{"top_left_x":167,"top_left_y":2221,"width":1331,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d37517c51354ce5bc60729001ffaa89","type":"text","conversion_output":true,"text":"used.\" The choice of pressure is discussed further below under section 4.5.2.","text_display":" used.\" The choice of pressure is discussed further below under section 4.5.2.","confidence":0.99951171875,"confidence_rate":0.9999940439141021},{"cnt":[[1901,2643],[1959,2643],[1959,2696],[1901,2696]],"region":{"top_left_x":1901,"top_left_y":2642,"width":59,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec99a3c01aae44f18a3100d46ac3c229","type":"page_info","conversion_output":false,"text":"19","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-20","page":20,"lines":[{"cnt":[[168,64],[1218,64],[1218,114],[168,114]],"region":{"top_left_x":167,"top_left_y":64,"width":1052,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b867fd2cf06452ea33e953528dc2c91","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) 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infants","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[150,352],[1904,352],[1904,1704],[150,1704]],"region":{"top_left_x":150,"top_left_y":352,"width":1754,"height":1352},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"672966da9e704da4b19d3510495fb824","type":"diagram","conversion_output":true,"selected_labels":["baedb157e71346fdb77ce4e45219dbed"],"text":"","text_display":"\n\n\\begin{figure}\n\\captionsetup{labelformat=empty}\n\\caption{Figure 1: The overall schema for eligible versus non-eligible infants}\n\\includegraphics[alt={},max 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2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[163,176],[651,176],[651,226],[163,226]],"region":{"top_left_x":163,"top_left_y":176,"width":488,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ee87b9ae475486ba387ccbe7029a706","type":"section_header","conversion_output":false,"children_ids":["89aae63bcbeb4867bfe49574d1f084d7"],"text":"","text_display":""},{"cnt":[[168,180],[647,180],[647,221],[168,221]],"region":{"top_left_x":167,"top_left_y":180,"width":480,"height":42},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89aae63bcbeb4867bfe49574d1f084d7","type":"text","conversion_output":true,"parent_id":"1ee87b9ae475486ba387ccbe7029a706","text":"4.5.1. Control Arm Infants","text_display":"\n\n\\subsection*{4.5.1. Control Arm Infants}","confidence":1,"confidence_rate":1},{"cnt":[[232,251],[1953,251],[1953,299],[232,299]],"region":{"top_left_x":232,"top_left_y":251,"width":1721,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fef303c6a9eb48909dde325d2d4dca57","type":"text","conversion_output":true,"text":"Infants randomized to this arm will follow standard NRP guidelines. While starting on CPAP, this may","text_display":"\n\nInfants randomized to this arm will follow standard NRP guidelines. While starting on CPAP, this may","confidence":1,"confidence_rate":1},{"cnt":[[234,309],[1910,309],[1910,357],[234,357]],"region":{"top_left_x":234,"top_left_y":309,"width":1676,"height":48},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0367fa9fcfa140ba99e580b67556aeeb","type":"text","conversion_output":true,"text":"include the provision of T-piece resuscitator (positive pressure) ventilation with peak pressures set","text_display":" include the provision of T-piece resuscitator (positive pressure) ventilation with peak pressures set","confidence":1,"confidence_rate":1},{"cnt":[[234,367],[1914,367],[1914,415],[234,415]],"region":{"top_left_x":234,"top_left_y":367,"width":1681,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f25bb3ad95184ee78b66e2b6aafdc7d8","type":"text","conversion_output":true,"text":"initially at \\(20 cm H _{2} O\\) for 15 seconds, and if needed subsequently, increased to peak pressure of 25","text_display":" initially at \\(20 cm H _{2} O\\) for 15 seconds, and if needed subsequently, increased to peak pressure of 25","confidence":0.7786428928375244,"confidence_rate":0.9979343450389531},{"cnt":[[234,425],[1732,425],[1732,475],[234,475]],"region":{"top_left_x":234,"top_left_y":425,"width":1498,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d7d25cc4d74468d9f5677184083cac2","type":"text","conversion_output":true,"text":"\\(H _{2} O cm\\), or as local clinical practices allow. Corrections by MR. SOPA are to be applied as","text_display":" \\(H _{2} O cm\\), or as local clinical practices allow. Corrections by MR. SOPA are to be applied as","confidence":0.9653487205505371,"confidence_rate":0.9996735174322693},{"cnt":[[234,486],[1729,486],[1729,533],[234,533]],"region":{"top_left_x":234,"top_left_y":485,"width":1496,"height":48},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b6a24540a8846f3bb213174ac7c16a5","type":"text","conversion_output":true,"text":"recommended by NRP guidelines. These are discussed in fuller detail below under 4.5.2.","text_display":" recommended by NRP guidelines. These are discussed in fuller detail below under 4.5.2.","confidence":1,"confidence_rate":1},{"cnt":[[165,576],[737,576],[737,625],[165,625]],"region":{"top_left_x":165,"top_left_y":575,"width":572,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7ea6376f4874c40a810dd0187088ad6","type":"section_header","conversion_output":false,"children_ids":["f96acfddbfdc4fc59510f92fa352e527"],"text":"","text_display":""},{"cnt":[[168,580],[733,580],[733,621],[168,621]],"region":{"top_left_x":167,"top_left_y":580,"width":566,"height":41},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f96acfddbfdc4fc59510f92fa352e527","type":"text","conversion_output":true,"parent_id":"d7ea6376f4874c40a810dd0187088ad6","text":"4.5.2. Intervention Arm Infants","text_display":"\n\n\\subsection*{4.5.2. Intervention Arm Infants}","confidence":0.9970703125,"confidence_rate":0.99991850367004},{"cnt":[[232,649],[1828,649],[1828,698],[232,698]],"region":{"top_left_x":232,"top_left_y":648,"width":1597,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b3bdc7e700440d2952d1a02333d5f76","type":"text","conversion_output":true,"text":"All respiratory support is to be administered via the T-piece resuscitator and either face mask,","text_display":"\n\nAll respiratory support is to be administered via the T-piece resuscitator and either face mask,","confidence":0.9990236759185791,"confidence_rate":0.9999903287497746},{"cnt":[[232,709],[1914,709],[1914,756],[232,756]],"region":{"top_left_x":232,"top_left_y":708,"width":1683,"height":49},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81e6bd1bc97540839dece7aad82c66ed","type":"text","conversion_output":true,"text":"nasopharyngeal tube (NPT) or a shortened endotracheal tube placed as an NPT. The Mountain trial","text_display":" nasopharyngeal tube (NPT) or a shortened endotracheal tube placed as an NPT. The Mountain trial","confidence":1,"confidence_rate":1},{"cnt":[[232,767],[1867,767],[1867,814],[232,814]],"region":{"top_left_x":232,"top_left_y":766,"width":1635,"height":49},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"476396212fd943439f345776883b540f","type":"text","conversion_output":true,"text":"has reported that there is no difference in interface. (Appendix 9) SI will be delivered via T-piece","text_display":" has reported that there is no difference in interface. (Appendix 9) SI will be delivered via T-piece","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[232,825],[1919,825],[1919,874],[232,874]],"region":{"top_left_x":232,"top_left_y":825,"width":1687,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5be9be82b1f5466a9dce3ba145b32a4d","type":"text","conversion_output":true,"text":"resuscitator, as this device has been shown to be the only one capable of effective delivery of CPAP","text_display":" resuscitator, as this device has been shown to be the only one capable of effective delivery of CPAP","confidence":1,"confidence_rate":1},{"cnt":[[232,885],[999,885],[999,932],[232,932]],"region":{"top_left_x":232,"top_left_y":885,"width":768,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69c85a1b94d14e379aa87613877b7af3","type":"text","conversion_output":true,"text":"and SI (Hussey SG 2004, Klingerberg C 2011).","text_display":" and SI (Hussey SG 2004, Klingerberg C 2011).","confidence":1,"confidence_rate":1},{"cnt":[[232,975],[1953,975],[1953,1025],[232,1025]],"region":{"top_left_x":232,"top_left_y":975,"width":1721,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"330bf642ceea44c8aabaf73c9edcdac1","type":"text","conversion_output":true,"text":"The choice of initial pressure for the SI is based on pathophysiology, literature, local practice or other","text_display":"\n\nThe choice of initial pressure for the SI is based on pathophysiology, literature, local practice or other","confidence":0.740234375,"confidence_rate":0.9974324605859551},{"cnt":[[232,1036],[1893,1036],[1893,1085],[232,1085]],"region":{"top_left_x":232,"top_left_y":1035,"width":1661,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ff49f089b4b48e29bfe19ab3721176f","type":"text","conversion_output":true,"text":"and available data. While animal studies suggest that inflation pressures as high as \\(35 cm H _{2} O\\) are","text_display":" and available data. While animal studies suggest that inflation pressures as high as \\(35 cm H _{2} O\\) are","confidence":0.9990234375,"confidence_rate":0.9999917200372636},{"cnt":[[232,1087],[1888,1087],[1888,1143],[232,1143]],"region":{"top_left_x":232,"top_left_y":1087,"width":1657,"height":56},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a5bbca2f23f48399844e98c9b447c57","type":"text","conversion_output":true,"text":"needed in animals with no spontaneous effort and no antenatal steroids \\({ }^{7-11}\\), human trials suggest","text_display":" needed in animals with no spontaneous effort and no antenatal steroids \\({ }^{7-11}\\), human trials suggest","confidence":1,"confidence_rate":1},{"cnt":[[232,1152],[1893,1152],[1893,1201],[232,1201]],"region":{"top_left_x":232,"top_left_y":1151,"width":1661,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9eb9f77b76954cf3be3602af2d245555","type":"text","conversion_output":true,"text":"that when the lungs are partially aerated as a result of the infant's respiratory effort, pressures as","text_display":" that when the lungs are partially aerated as a result of the infant's respiratory effort, pressures as","confidence":1,"confidence_rate":1},{"cnt":[[232,1212],[1895,1212],[1895,1259],[232,1259]],"region":{"top_left_x":232,"top_left_y":1211,"width":1663,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed263c334ff24076b68881d5952f5f0e","type":"text","conversion_output":true,"text":"low as \\(20 cm H _{2} O\\) may be sufficient. A single SI with a pressure of \\(25 cm H _{2} O\\) was used in a recent","text_display":" low as \\(20 cm H _{2} O\\) may be sufficient. A single SI with a pressure of \\(25 cm H _{2} O\\) was used in a recent","confidence":0.9486717355034819,"confidence_rate":0.9996182435694361},{"cnt":[[232,1263],[1880,1263],[1880,1317],[232,1317]],"region":{"top_left_x":232,"top_left_y":1263,"width":1648,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cd6db3459024c0781e28ab202e5146b","type":"text","conversion_output":true,"text":"cohort study \\({ }^{12}\\) without apparent adverse effects. Escalating SI pressure ranging from 20 to 30 cm","text_display":" cohort study \\({ }^{12}\\) without apparent adverse effects. Escalating SI pressure ranging from 20 to 30 cm","confidence":0.9574239253997803,"confidence_rate":0.9996249926400566},{"cnt":[[232,1328],[1951,1328],[1951,1377],[232,1377]],"region":{"top_left_x":232,"top_left_y":1327,"width":1719,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f82638b0db049ebbf746d168c5c43c9","type":"text","conversion_output":true,"text":"\\(H _{2} O\\) for up to 3 SIs was used by the other two studies. The first reported that \\(67 \\%\\) of infants required","text_display":" \\(H _{2} O\\) for up to 3 SIs was used by the other two studies. The first reported that \\(67 \\%\\) of infants required","confidence":0.7579078137672497,"confidence_rate":0.9978197540668193},{"cnt":[[232,1379],[1888,1379],[1888,1433],[232,1433]],"region":{"top_left_x":232,"top_left_y":1379,"width":1657,"height":55},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c409f5bb5c7f4e02b364cf7c070500bf","type":"text","conversion_output":true,"text":"25 cm and \\(8 \\%\\) received SI of \\(30 cm H _{2} O .^{13} SIs\\) of \\(20 cm H _{2} O\\) were adequate in \\(60 \\%\\) of infant in the","text_display":" 25 cm and \\(8 \\%\\) received SI of \\(30 cm H _{2} O .^{13} SIs\\) of \\(20 cm H _{2} O\\) were adequate in \\(60 \\%\\) of infant in the","confidence":0.5885867994143458,"confidence_rate":0.9965190274806712},{"cnt":[[232,1446],[1897,1446],[1897,1493],[232,1493]],"region":{"top_left_x":232,"top_left_y":1445,"width":1666,"height":49},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"831dab0e2aea4a9b84e73c6128d1000e","type":"text","conversion_output":true,"text":"other trial, while \\(40 \\%\\) of infants required \\(25 cm H _{2} O\\) and of those, the majority had an inadequate","text_display":" other trial, while \\(40 \\%\\) of infants required \\(25 cm H _{2} O\\) and of those, the majority had an inadequate","confidence":0.9980475902557373,"confidence_rate":0.9999837141477775},{"cnt":[[232,1495],[1861,1495],[1861,1551],[232,1551]],"region":{"top_left_x":232,"top_left_y":1495,"width":1629,"height":57},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1f2505abf53430baeee2483ed8cc189","type":"text","conversion_output":true,"text":"response and required intubation \\({ }^{14}\\). At that center, Sl of up to \\(30 cm H _{2} O\\) is now used as part of","text_display":" response and required intubation \\({ }^{14}\\). At that center, Sl of up to \\(30 cm H _{2} O\\) is now used as part of","confidence":0.6177669057615276,"confidence_rate":0.9964905225321155},{"cnt":[[232,1564],[541,1564],[541,1605],[232,1605]],"region":{"top_left_x":232,"top_left_y":1564,"width":310,"height":41},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97702b428b5d4769bf8934f5fa5e29e8","type":"text","conversion_output":true,"text":"standard DR care.","text_display":" standard DR care.","confidence":1,"confidence_rate":1},{"cnt":[[232,1654],[1833,1654],[1833,1704],[232,1704]],"region":{"top_left_x":232,"top_left_y":1654,"width":1601,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f317fa7357634688bdfe4f2664af7141","type":"text","conversion_output":true,"text":"Thus, eligible infants will be given the first Sl using pressure of \\(20 cm H _{2} O\\). An assessment for","text_display":"\n\nThus, eligible infants will be given the first Sl using pressure of \\(20 cm H _{2} O\\). An assessment for","confidence":0.3616552151171584,"confidence_rate":0.9918965000935801},{"cnt":[[232,1714],[1893,1714],[1893,1764],[232,1764]],"region":{"top_left_x":232,"top_left_y":1714,"width":1661,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51e1e128f9b348b9806fa18f67678e26","type":"text","conversion_output":true,"text":"respiratory effort and heart rate will be made. Infants with adequate respiratory effort and heart","text_display":" respiratory effort and heart rate will be made. Infants with adequate respiratory effort and heart","confidence":1,"confidence_rate":1},{"cnt":[[232,1772],[1876,1772],[1876,1820],[232,1820]],"region":{"top_left_x":232,"top_left_y":1772,"width":1644,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5d38db7a8744ed6b188ad79dd7e1c8e","type":"text","conversion_output":true,"text":"rate above 100 bpm will continue on CPAP as study intervention has ended for these infants and","text_display":" rate above 100 bpm will continue on CPAP as study intervention has ended for these infants and","confidence":0.7176971435546875,"confidence_rate":0.9967532468007139},{"cnt":[[232,1830],[926,1830],[926,1880],[232,1880]],"region":{"top_left_x":232,"top_left_y":1830,"width":694,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b23c393ba5e741849fcdc2767c1c7633","type":"text","conversion_output":true,"text":"they revert to standard NRP procedures.","text_display":" they revert to standard NRP procedures.","confidence":1,"confidence_rate":1},{"cnt":[[232,1925],[1910,1925],[1910,1972],[232,1972]],"region":{"top_left_x":232,"top_left_y":1925,"width":1678,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8cdf6471227a41b9be56b2e99d908703","type":"text","conversion_output":true,"text":"For those infants following the first SI who remain without adequate respiratory effort, a second SI","text_display":"\n\nFor those infants following the first SI who remain without adequate respiratory effort, a second SI","confidence":0.9931755065917969,"confidence_rate":0.9999347841575414},{"cnt":[[232,1981],[1910,1981],[1910,2030],[232,2030]],"region":{"top_left_x":232,"top_left_y":1980,"width":1678,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f535885f0844f47a5223122bfa08288","type":"text","conversion_output":true,"text":"using a pressure of \\(25 cm H _{2} O\\) for 15 seconds will be delivered. In the interval between the first SI","text_display":" using a pressure of \\(25 cm H _{2} O\\) for 15 seconds will be delivered. In the interval between the first SI","confidence":0.880859375,"confidence_rate":0.9989856565102114},{"cnt":[[232,2041],[1944,2041],[1944,2090],[232,2090]],"region":{"top_left_x":232,"top_left_y":2041,"width":1713,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6aa512ffe5e643eda29935f33bd5cc70","type":"text","conversion_output":true,"text":"and the second SI, the team will follow standard NRP procedures as described in the next paragraph","text_display":" and the second SI, the team will follow standard NRP procedures as described in the next paragraph","confidence":0.5065810680389404,"confidence_rate":0.9934191192478877},{"cnt":[[232,2099],[1843,2099],[1843,2151],[232,2151]],"region":{"top_left_x":232,"top_left_y":2099,"width":1612,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca8283c77014419881f6840ce4ff7540","type":"text","conversion_output":true,"text":"(MR SOPA). Decisions about adequacy of the SI will be based on infant's response as judged by","text_display":" (MR SOPA). Decisions about adequacy of the SI will be based on infant's response as judged by","confidence":0.9990234375,"confidence_rate":0.9999900302573734},{"cnt":[[232,2157],[965,2157],[965,2206],[232,2206]],"region":{"top_left_x":232,"top_left_y":2157,"width":733,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2449f70eb6134502997fe9f335689939","type":"text","conversion_output":true,"text":"improving HR , respiratory effort and \\(SPO _{2}\\).","text_display":" improving HR , respiratory effort and \\(SPO _{2}\\).","confidence":0.9482421875,"confidence_rate":0.9992187562518714},{"cnt":[[234,2252],[1910,2252],[1910,2301],[234,2301]],"region":{"top_left_x":234,"top_left_y":2251,"width":1676,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc085be42fa54c91a797a38d915d5b66","type":"text","conversion_output":true,"text":"During this period between Sis, as per NRP recommendations, adjustments can be made to ensure","text_display":"\n\nDuring this period between Sis, as per NRP recommendations, adjustments can be made to ensure","confidence":1,"confidence_rate":1},{"cnt":[[232,2312],[1927,2312],[1927,2359],[232,2359]],"region":{"top_left_x":232,"top_left_y":2311,"width":1696,"height":48},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d858deffec345d8b00ba476e9ac2bdf","type":"text","conversion_output":true,"text":"no residual lack of seal or obstruction is impeding the infant, resuscitation will proceed according to","text_display":" no residual lack of seal or obstruction is impeding the infant, resuscitation will proceed according to","confidence":1,"confidence_rate":1},{"cnt":[[232,2368],[1921,2368],[1921,2417],[232,2417]],"region":{"top_left_x":232,"top_left_y":2367,"width":1689,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c3e3a76912848a6a972fe7dd76a00db","type":"text","conversion_output":true,"text":"the first four steps of the \"MR. SOPA rule\". (i.e. Mask Readjustment; Suction airway; Open mouth.)","text_display":" the first four steps of the \"MR. SOPA rule\". (i.e. Mask Readjustment; Suction airway; Open mouth.)","confidence":1,"confidence_rate":1},{"cnt":[[232,2426],[1927,2426],[1927,2475],[232,2475]],"region":{"top_left_x":232,"top_left_y":2425,"width":1696,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ca8b94afede476e83310ce575383ce0","type":"text","conversion_output":true,"text":"In both the NRP algorithm as well as the SI algorithm, MR. SOPA is incorporated in the step outlined","text_display":" In both the NRP algorithm as well as the SI algorithm, MR. SOPA is incorporated in the step outlined","confidence":1,"confidence_rate":1},{"cnt":[[232,2484],[1884,2484],[1884,2533],[232,2533]],"region":{"top_left_x":232,"top_left_y":2483,"width":1653,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a51932204154204adf8fc77fea0834b","type":"text","conversion_output":true,"text":"as \"take corrective ventilation steps\". Last, if the infant is eligible for a second SI , the clinician will","text_display":" as \"take corrective ventilation steps\". Last, if the infant is eligible for a second SI , the clinician will","confidence":0.9756195545196533,"confidence_rate":0.9997926049609372},{"cnt":[[1904,2643],[1955,2643],[1955,2696],[1904,2696]],"region":{"top_left_x":1903,"top_left_y":2642,"width":53,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b381c259a0d4e11bdc3c343ae64b74e","type":"page_info","conversion_output":false,"text":"21","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-22","page":22,"lines":[{"cnt":[[168,64],[1222,64],[1222,116],[168,116]],"region":{"top_left_x":167,"top_left_y":64,"width":1056,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d3c6c0556ed4e8f8f46742e2a146fa1","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) Study","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999912786005654},{"cnt":[[1491,64],[1916,64],[1916,114],[1491,114]],"region":{"top_left_x":1491,"top_left_y":64,"width":426,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a268513360fe411d9fa2ad8d94f27817","type":"page_info","conversion_output":false,"text":"Version 2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[232,178],[1794,178],[1794,228],[232,228]],"region":{"top_left_x":232,"top_left_y":178,"width":1562,"height":50},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb7463ad6e88462dbdb10ee3c812075b","type":"text","conversion_output":true,"text":"ensure airway patency and deliver the second SI with a pressure 5 cm higher than the initial","text_display":"\nensure airway patency and deliver the second SI with a pressure 5 cm higher than the initial","confidence":0.9794921875,"confidence_rate":0.9997968734012613},{"cnt":[[232,236],[1336,236],[1336,286],[232,286]],"region":{"top_left_x":232,"top_left_y":236,"width":1105,"height":50},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc187f7ed70844da81f8be6a674c818e","type":"text","conversion_output":true,"text":"pressure. This step is in accordance with the \\(P\\) step of MR. SOPA.","text_display":" pressure. This step is in accordance with the \\(P\\) step of MR. SOPA.","confidence":0.811304539674893,"confidence_rate":0.9971395539073797},{"cnt":[[232,331],[1886,331],[1886,380],[232,380]],"region":{"top_left_x":232,"top_left_y":330,"width":1655,"height":51},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"719a3a23a11d43cfac34c63e733461cb","type":"text","conversion_output":true,"text":"The final 'A' in MR. SOPA stands for Airway. There will be rare situations where the clinician must","text_display":"\n\nThe final 'A' in MR. SOPA stands for Airway. There will be rare situations where the clinician must","confidence":0.9931671619415283,"confidence_rate":0.9999340763193997},{"cnt":[[232,387],[1897,387],[1897,436],[232,436]],"region":{"top_left_x":232,"top_left_y":386,"width":1666,"height":51},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"61eb2e045e224ba6b543172124573d5f","type":"text","conversion_output":true,"text":"respond with intubation immediately - such infants will be also randomized into an SI or standard","text_display":" respond with intubation immediately - such infants will be also randomized into an SI or standard","confidence":0.9951240993104875,"confidence_rate":0.9999520812787691},{"cnt":[[232,447],[1803,447],[1803,496],[232,496]],"region":{"top_left_x":232,"top_left_y":446,"width":1571,"height":51},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c513e14aba27434f83dff9842a99e533","type":"text","conversion_output":true,"text":"arm. While these infants data will be pooled, it will also be treated separately in a sub-group","text_display":" arm. While these infants data will be pooled, it will also be treated separately in a sub-group","confidence":1,"confidence_rate":1},{"cnt":[[232,507],[1910,507],[1910,554],[232,554]],"region":{"top_left_x":232,"top_left_y":507,"width":1678,"height":48},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4bf9ba91858e4f74aef8473618a5738b","type":"text","conversion_output":true,"text":"analysis. At any point in the algorithm, if the HR is \\(<60\\) and not increasing, PPV may be given with","text_display":" analysis. At any point in the algorithm, if the HR is \\(<60\\) and not increasing, PPV may be given with","confidence":0.5099048614501953,"confidence_rate":0.993725086680428},{"cnt":[[232,563],[1921,563],[1921,612],[232,612]],"region":{"top_left_x":232,"top_left_y":562,"width":1689,"height":51},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3b3a6ab0cf20437390c31b6e17b0ecba","type":"text","conversion_output":true,"text":"rate in accordance with NRP and peak inspiratory pressure equal to the SI that would otherwise be","text_display":" rate in accordance with NRP and peak inspiratory pressure equal to the SI that would otherwise be","confidence":1,"confidence_rate":1},{"cnt":[[232,623],[1897,623],[1897,672],[232,672]],"region":{"top_left_x":232,"top_left_y":623,"width":1666,"height":50},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a2fd40440ad94f87884bfec14950001f","type":"text","conversion_output":true,"text":"performed. Observation after a 15 second period will assess whether there is an improving heart","text_display":" performed. Observation after a 15 second period will assess whether there is an improving heart","confidence":0.9990236759185791,"confidence_rate":0.9999905165401506},{"cnt":[[232,683],[1901,683],[1901,730],[232,730]],"region":{"top_left_x":232,"top_left_y":683,"width":1670,"height":48},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6e57003d043a41158e706095dd1107e5","type":"text","conversion_output":true,"text":"rate. If the heart rate improves to \\(>60\\), the algorithm will be resumed from the point of departure.","text_display":" rate. If the heart rate improves to \\(>60\\), the algorithm will be resumed from the point of departure.","confidence":1,"confidence_rate":1},{"cnt":[[232,776],[1884,776],[1884,823],[232,823]],"region":{"top_left_x":232,"top_left_y":775,"width":1653,"height":48},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"11c9e90d8a2946988990a2b0de93a4d0","type":"text","conversion_output":true,"text":"Throughout the entire period, cardiac compressions will start if HR remains < 60 despite effective","text_display":"\n\nThroughout the entire period, cardiac compressions will start if HR remains < 60 despite effective","confidence":0.9980480668600649,"confidence_rate":0.9999815677109707},{"cnt":[[232,834],[866,834],[866,881],[232,881]],"region":{"top_left_x":232,"top_left_y":833,"width":634,"height":48},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6e93f3f197934e13a0bc0184a9895c64","type":"text","conversion_output":true,"text":"respiratory support for > 30 seconds.","text_display":" respiratory support for > 30 seconds.","confidence":0.8208419191651046,"confidence_rate":0.9956223934469834},{"cnt":[[232,928],[1876,928],[1876,975],[232,975]],"region":{"top_left_x":232,"top_left_y":928,"width":1644,"height":48},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bb948fbd9e0147a4bf4fbc810ac3ac5a","type":"text","conversion_output":true,"text":"Finally, Figure 1 shows two red lines. The first is the initial assessment point which by 30 seconds","text_display":"\n\nFinally, Figure 1 shows two red lines. The first is the initial assessment point which by 30 seconds","confidence":0.9990234375,"confidence_rate":0.9999911978797494},{"cnt":[[232,984],[1858,984],[1858,1033],[232,1033]],"region":{"top_left_x":232,"top_left_y":983,"width":1627,"height":51},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1a99f9686d54480d8ec0426b214dfd18","type":"text","conversion_output":true,"text":"must be completed as according to NRP. However the second dotted redline indicates that by 5","text_display":" must be completed as according to NRP. However the second dotted redline indicates that by 5","confidence":0.99951171875,"confidence_rate":0.9999949125077527},{"cnt":[[232,1044],[1936,1044],[1936,1094],[232,1094]],"region":{"top_left_x":232,"top_left_y":1044,"width":1704,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"69277c02495e4228b4654533dd0ae5b4","type":"text","conversion_output":true,"text":"minutes there may have been a progression towards intubation. This decision point may be reached","text_display":" minutes there may have been a progression towards intubation. This decision point may be reached","confidence":1,"confidence_rate":1},{"cnt":[[232,1102],[728,1102],[728,1149],[232,1149]],"region":{"top_left_x":232,"top_left_y":1102,"width":497,"height":48},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d649e1eb699d48ada25ba1f94c2fac19","type":"text","conversion_output":true,"text":"by 2 minutes or even before.","text_display":" by 2 minutes or even before.","confidence":1,"confidence_rate":1},{"cnt":[[232,1195],[1884,1195],[1884,1244],[232,1244]],"region":{"top_left_x":232,"top_left_y":1194,"width":1653,"height":50},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"31f55c83e7b542ee9377804336ba3c19","type":"text","conversion_output":true,"text":"The modified but NRP compatible procedures are shown for the SI arm in more detail in Figure 2.","text_display":"\n\nThe modified but NRP compatible procedures are shown for the SI arm in more detail in Figure 2.","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[1904,2643],[1955,2643],[1955,2686],[1904,2686]],"region":{"top_left_x":1903,"top_left_y":2642,"width":53,"height":44},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2564b976d3e6427482ce4eb6d6095293","type":"page_info","conversion_output":false,"text":"22","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-23","page":23,"lines":[{"cnt":[[168,64],[1222,64],[1222,116],[168,116]],"region":{"top_left_x":167,"top_left_y":64,"width":1056,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e575be3d2e6d4b9696d15ceccc0c19ee","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) Study","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999912786005654},{"cnt":[[1495,64],[1916,64],[1916,114],[1495,114]],"region":{"top_left_x":1495,"top_left_y":64,"width":422,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"47fc45f286a242b398ec16db198dce15","type":"page_info","conversion_output":false,"text":"Version 2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[168,176],[1729,176],[1729,230],[168,230]],"region":{"top_left_x":167,"top_left_y":176,"width":1563,"height":54},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7bc3da0fda8c4394b7d09dabcad359a7","type":"figure_label","conversion_output":false,"text":"Figure 2: Algorithm For infants In Intervention arm directly compared to the NRP algorithm.","text_display":"","confidence":0.69580078125,"confidence_rate":0.9962290872591665},{"cnt":[[180,247],[1794,247],[1794,1794],[180,1794]],"region":{"top_left_x":180,"top_left_y":247,"width":1614,"height":1547},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dc2c853ba66b49fc8acadde9b32db98c","type":"diagram","conversion_output":true,"selected_labels":["7bc3da0fda8c4394b7d09dabcad359a7"],"text":"","text_display":"\n\n\\begin{figure}\n\\captionsetup{labelformat=empty}\n\\caption{Figure 2: Algorithm For infants In Intervention arm directly compared to the NRP algorithm.}\n\\includegraphics[alt={},max width=\\textwidth]{https://cdn.mathpix.com/cropped/0acb697e-f405-4a6e-b315-cce91483f079-23.jpg?height=1547&width=1614&top_left_y=247&top_left_x=180}\n\\end{figure}"},{"cnt":[[387,1861],[1532,1861],[1532,1951],[387,1951]],"region":{"top_left_x":386,"top_left_y":1860,"width":1146,"height":91},"line":5,"column":0,"font_size":56,"is_printed":true,"is_handwritten":false,"id":"3a51546a22974e15873ff042e2d180cc","type":"section_header","conversion_output":false,"children_ids":["fc64cb40bd0644718bfbfedb115615fd"],"text":"","text_display":""},{"cnt":[[391,1865],[1525,1865],[1525,1944],[391,1944]],"region":{"top_left_x":391,"top_left_y":1864,"width":1135,"height":81},"line":6,"column":0,"font_size":56,"is_printed":true,"is_handwritten":false,"id":"fc64cb40bd0644718bfbfedb115615fd","type":"text","conversion_output":true,"parent_id":"3a51546a22974e15873ff042e2d180cc","text":"Control Arm: NRP Sustained Inflation Arm","text_display":"\n\n\\section*{Control Arm: NRP Sustained Inflation Arm}","confidence":0.9990236759185791,"confidence_rate":0.9999782935467836},{"cnt":[[168,2013],[1833,2013],[1833,2065],[168,2065]],"region":{"top_left_x":167,"top_left_y":2013,"width":1666,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac2ea7d2a3874e6cad988eac7ec72957","type":"text","conversion_output":true,"text":"The potential risks of this maneuver are described in Section 8 and in the adverse event reporting","text_display":"\n\nThe potential risks of this maneuver are described in Section 8 and in the adverse event reporting","confidence":0.9960954189300537,"confidence_rate":0.9999630929089357},{"cnt":[[168,2071],[1897,2071],[1897,2123],[168,2123]],"region":{"top_left_x":167,"top_left_y":2071,"width":1731,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa5d380149724a1c816a951e0040bd4a","type":"text","conversion_output":true,"text":"section. The main risk anticipated is the potential for a pneumothorax. However, we do note that not","text_display":" section. The main risk anticipated is the potential for a pneumothorax. However, we do note that not","confidence":1,"confidence_rate":1},{"cnt":[[168,2127],[1824,2127],[1824,2181],[168,2181]],"region":{"top_left_x":167,"top_left_y":2126,"width":1658,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb4b6f801b2a4ccbb259e7d4e415790b","type":"text","conversion_output":true,"text":"only has an excess risk not been seen in the available randomized data to date, but the pressures","text_display":" only has an excess risk not been seen in the available randomized data to date, but the pressures","confidence":1,"confidence_rate":1},{"cnt":[[168,2187],[1826,2187],[1826,2241],[168,2241]],"region":{"top_left_x":167,"top_left_y":2187,"width":1660,"height":54},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96187b131424472789af9a6a32a1c6b0","type":"text","conversion_output":true,"text":"stipulated in the algorithm are within the ranges of those recommended by NRP for conventional","text_display":" stipulated in the algorithm are within the ranges of those recommended by NRP for conventional","confidence":1,"confidence_rate":1},{"cnt":[[168,2245],[1824,2245],[1824,2299],[168,2299]],"region":{"top_left_x":167,"top_left_y":2245,"width":1658,"height":54},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea8a9c735c0649ec8fd68a46a1a3289b","type":"text","conversion_output":true,"text":"resuscitation. The DCC will monitor carefully for potential excess risk, and some of the secondary","text_display":" resuscitation. The DCC will monitor carefully for potential excess risk, and some of the secondary","confidence":1,"confidence_rate":1},{"cnt":[[168,2305],[1755,2305],[1755,2357],[168,2357]],"region":{"top_left_x":167,"top_left_y":2305,"width":1589,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1533aef32834404a811e36e015a91ae","type":"text","conversion_output":true,"text":"objectives are also part of the materials in adverse event reporting and will be transmitted at","text_display":" objectives are also part of the materials in adverse event reporting and will be transmitted at","confidence":1,"confidence_rate":1},{"cnt":[[168,2363],[771,2363],[771,2417],[168,2417]],"region":{"top_left_x":167,"top_left_y":2363,"width":605,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40e2f2a44a3448a29bbf32de54d227d9","type":"text","conversion_output":true,"text":"appropriate intervals to the DSMC.","text_display":" appropriate intervals to the DSMC.","confidence":0.99072265625,"confidence_rate":0.9997610376244274},{"cnt":[[1904,2643],[1957,2643],[1957,2696],[1904,2696]],"region":{"top_left_x":1903,"top_left_y":2642,"width":55,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"252b6fd6a2e04cc38112b3cc8a6dc958","type":"page_info","conversion_output":false,"text":"23","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-24","page":24,"lines":[{"cnt":[[168,64],[1218,64],[1218,114],[168,114]],"region":{"top_left_x":167,"top_left_y":64,"width":1052,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb2ffdfb681d4f428137710bf2567912","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) Study","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1495,64],[1914,64],[1914,114],[1495,114]],"region":{"top_left_x":1495,"top_left_y":64,"width":420,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"939d5cad7c3a4eef86d912fb64a35ca7","type":"page_info","conversion_output":false,"text":"Version 2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[165,176],[982,176],[982,230],[165,230]],"region":{"top_left_x":165,"top_left_y":176,"width":817,"height":54},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"769158759aeb411f9107676f1654f162","type":"section_header","conversion_output":false,"children_ids":["bc67f7ed9fe343bc91c8c46049b0e238"],"text":"","text_display":""},{"cnt":[[168,180],[978,180],[978,226],[168,226]],"region":{"top_left_x":167,"top_left_y":180,"width":811,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc67f7ed9fe343bc91c8c46049b0e238","type":"text","conversion_output":true,"parent_id":"769158759aeb411f9107676f1654f162","text":"4.5.3. Data Collection for Non-eligible Infants","text_display":"\n\n\\subsection*{4.5.3. Data Collection for Non-eligible Infants}","confidence":0.99951171875,"confidence_rate":0.9999906077268363},{"cnt":[[232,251],[1946,251],[1946,299],[232,299]],"region":{"top_left_x":232,"top_left_y":251,"width":1715,"height":48},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3467dc67483a435ab48752dba1a3fa05","type":"text","conversion_output":true,"text":"To complete the patient flow description, this protocol addresses infants in the inclusion GA who are","text_display":"\n\nTo complete the patient flow description, this protocol addresses infants in the inclusion GA who are","confidence":1,"confidence_rate":1},{"cnt":[[232,309],[1811,309],[1811,357],[232,357]],"region":{"top_left_x":232,"top_left_y":309,"width":1580,"height":48},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9589ec99d3e41ecabf61445434e9ad4","type":"text","conversion_output":true,"text":"not eligible to be randomized. By definition this includes infants whose parent has refused to","text_display":" not eligible to be randomized. By definition this includes infants whose parent has refused to","confidence":1,"confidence_rate":1},{"cnt":[[232,370],[1904,370],[1904,415],[232,415]],"region":{"top_left_x":232,"top_left_y":369,"width":1672,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f68e097f0b94051b05941cbf986dee8","type":"text","conversion_output":true,"text":"consent. We seek approval to capture limited data for this group of infants. There are two reasons","text_display":" consent. We seek approval to capture limited data for this group of infants. There are two reasons","confidence":1,"confidence_rate":1},{"cnt":[[232,425],[904,425],[904,475],[232,475]],"region":{"top_left_x":232,"top_left_y":425,"width":673,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4c82f8d4df7418b9cab356920ba2e64","type":"text","conversion_output":true,"text":"for collecting this valuable information:","text_display":" for collecting this valuable information:","confidence":1,"confidence_rate":1},{"cnt":[[296,524],[1729,524],[1729,569],[296,569]],"region":{"top_left_x":296,"top_left_y":524,"width":1434,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4ced872134545fe9b23852b13923b4c","type":"text","conversion_output":true,"text":"- The dearth of information about DR practices in this birthweight range of infants","text_display":"\n- The dearth of information about DR practices in this birthweight range of infants","confidence":1,"confidence_rate":1},{"cnt":[[296,619],[1755,619],[1755,664],[296,664]],"region":{"top_left_x":296,"top_left_y":618,"width":1460,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1fed2a0f812f4b35924e97ca855db33a","type":"text","conversion_output":true,"text":"- The known high potential for selection bias following the use of antenatal consent","text_display":"\n- The known high potential for selection bias following the use of antenatal consent","confidence":1,"confidence_rate":1},{"cnt":[[357,666],[638,666],[638,724],[357,724]],"region":{"top_left_x":356,"top_left_y":666,"width":283,"height":59},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90ec812848c64917ae243099fef085ec","type":"text","conversion_output":true,"text":"procedures. \\({ }^{17,18}\\)","text_display":" procedures. \\({ }^{17,18}\\)","confidence":0.99951171875,"confidence_rate":0.9999825572771935},{"cnt":[[234,769],[1936,769],[1936,816],[234,816]],"region":{"top_left_x":234,"top_left_y":769,"width":1702,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8560530e1d84de6883dc8295ca8e0eb","type":"text","conversion_output":true,"text":"Data Collection for these infants will not include any HIPPA protected priviliged information. We will","text_display":"\n\nData Collection for these infants will not include any HIPPA protected priviliged information. 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This video can be accessed","text_display":" has been alerted that a potentially eligible SAIL baby may be born shortly. This video can be accessed","confidence":1,"confidence_rate":1},{"cnt":[[232,2084],[1927,2084],[1927,2133],[232,2133]],"region":{"top_left_x":232,"top_left_y":2083,"width":1696,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89f050f1b1734e1294c6975f5a5bcb00","type":"text","conversion_output":true,"text":"from the SAIL Trial Website which will be created and maintained by the DCC. Should any university","text_display":" from the SAIL Trial Website which will be created and maintained by the DCC. Should any university","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[232,2142],[1755,2142],[1755,2189],[232,2189]],"region":{"top_left_x":232,"top_left_y":2141,"width":1524,"height":49},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98dde8abb74647b88e57495017f1ce3d","type":"text","conversion_output":true,"text":"site deem this an unsafe site, the video will be sent as a file to the respective hospital site","text_display":" site deem this an unsafe site, the video will be sent as a file to the respective hospital site","confidence":1,"confidence_rate":1},{"cnt":[[232,2202],[1897,2202],[1897,2249],[232,2249]],"region":{"top_left_x":232,"top_left_y":2202,"width":1666,"height":48},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"91af728ade454744bb31095c4f4ad7a1","type":"text","conversion_output":true,"text":"coordinator to load on appropriate computers.Should any university site deem this an unsafe site,","text_display":" coordinator to load on appropriate computers.Should any university site deem this an unsafe site,","confidence":0.994631290435791,"confidence_rate":0.9999472251879841},{"cnt":[[232,2260],[1852,2260],[1852,2305],[232,2305]],"region":{"top_left_x":232,"top_left_y":2260,"width":1620,"height":46},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba6a3360cf38427d8093218c69a52a4d","type":"text","conversion_output":true,"text":"the video will be sent as a file to the respective hospital site coordinator to load on appropriate","text_display":" the video will be sent as a file to the respective hospital site coordinator to load on appropriate","confidence":1,"confidence_rate":1},{"cnt":[[232,2320],[423,2320],[423,2365],[232,2365]],"region":{"top_left_x":232,"top_left_y":2320,"width":192,"height":46},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85d1e3da73c74197b56a418d0085fb83","type":"text","conversion_output":true,"text":"computers","text_display":" computers","confidence":1,"confidence_rate":1},{"cnt":[[1904,2643],[1955,2643],[1955,2694],[1904,2694]],"region":{"top_left_x":1903,"top_left_y":2642,"width":53,"height":53},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38b94c293dfb49b5bfe1b63a59a09cb3","type":"page_info","conversion_output":false,"text":"24","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-25","page":25,"lines":[{"cnt":[[168,62],[1222,62],[1222,116],[168,116]],"region":{"top_left_x":167,"top_left_y":62,"width":1056,"height":55},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f28c13352d7643caa63667b284dbca60","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) Study","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1491,62],[1916,62],[1916,114],[1491,114]],"region":{"top_left_x":1491,"top_left_y":62,"width":426,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"701e8c2c00da45ff9d83cfb403ef0236","type":"page_info","conversion_output":false,"text":"Version 2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[230,178],[1803,178],[1803,230],[230,230]],"region":{"top_left_x":229,"top_left_y":178,"width":1574,"height":52},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a3d081e9e2c649ec800d0c85fe717f74","type":"text","conversion_output":true,"text":"To assess fidelity of the research intervention across sites, a variety of methods will be used.","text_display":"\n\nTo assess fidelity of the research intervention across sites, a variety of methods will be used.","confidence":1,"confidence_rate":1},{"cnt":[[292,236],[1895,236],[1895,290],[292,290]],"region":{"top_left_x":292,"top_left_y":236,"width":1603,"height":55},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b61c587e34964479bb785829279a954a","type":"text","conversion_output":true,"text":"- A main feature of our methods here hinge on the use of video recordings. Video capability","text_display":"\n- A main feature of our methods here hinge on the use of video recordings. Video capability","confidence":1,"confidence_rate":1},{"cnt":[[357,296],[1841,296],[1841,346],[357,346]],"region":{"top_left_x":356,"top_left_y":296,"width":1486,"height":50},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6bc581319d9645a49ae32869c7970adb","type":"text","conversion_output":true,"text":"during resuscitation for quality control purposes is available at UCSD, Calgary, Ulm, and","text_display":" during resuscitation for quality control purposes is available at UCSD, Calgary, Ulm, and","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[357,357],[1953,357],[1953,406],[357,406]],"region":{"top_left_x":356,"top_left_y":356,"width":1597,"height":51},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7a940f15840a47c9b8a65d6acffb5ddd","type":"text","conversion_output":true,"text":"Milan. A random sample of infants at each of these sites will be evaluated by the quality team","text_display":" Milan. A random sample of infants at each of these sites will be evaluated by the quality team","confidence":1,"confidence_rate":1},{"cnt":[[357,412],[1665,412],[1665,466],[357,466]],"region":{"top_left_x":356,"top_left_y":412,"width":1310,"height":55},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f3dc42378ba04a68b4d4e19295a5a365","type":"text","conversion_output":true,"text":"(led by the Philadelphia team of Drs. Ades, Foglia, Posencheg, and Nadkarni).","text_display":" (led by the Philadelphia team of Drs. Ades, Foglia, Posencheg, and Nadkarni).","confidence":0.99853515625,"confidence_rate":0.9999821231148849},{"cnt":[[294,511],[1897,511],[1897,561],[294,561]],"region":{"top_left_x":294,"top_left_y":511,"width":1604,"height":50},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8650e5febc1241218b009f83946dc64e","type":"text","conversion_output":true,"text":"- A training checklist will be generated for those who perform SI and will include simulation.","text_display":"\n- A training checklist will be generated for those who perform SI and will include simulation.","confidence":0.990234375,"confidence_rate":0.9999008774235902},{"cnt":[[357,567],[1867,567],[1867,621],[357,621]],"region":{"top_left_x":356,"top_left_y":567,"width":1511,"height":54},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"247814cae61f408a8c007cd3b2957d6e","type":"text","conversion_output":true,"text":"The PI at each site will be responsible to ensure that each person performing SI has been","text_display":" The PI at each site will be responsible to ensure that each person performing SI has been","confidence":0.9810042381286621,"confidence_rate":0.9998190871288452},{"cnt":[[357,627],[651,627],[651,677],[357,677]],"region":{"top_left_x":356,"top_left_y":627,"width":295,"height":50},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c9bb34b1386449318d1a6666259bd60e","type":"text","conversion_output":true,"text":"properly trained.","text_display":" properly trained.","confidence":1,"confidence_rate":1},{"cnt":[[163,713],[1063,713],[1063,776],[163,776]],"region":{"top_left_x":163,"top_left_y":713,"width":901,"height":63},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11238d6fcbc64f60ba6a962ac1bec7f3","type":"section_header","conversion_output":false,"children_ids":["6d5f41475c8f42cfb80e9916e3418616"],"text":"","text_display":""},{"cnt":[[168,718],[1059,718],[1059,771],[168,771]],"region":{"top_left_x":167,"top_left_y":717,"width":893,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d5f41475c8f42cfb80e9916e3418616","type":"text","conversion_output":true,"parent_id":"11238d6fcbc64f60ba6a962ac1bec7f3","text":"4.6. Random Allocation in the Delivery Room","text_display":"\n\n\\subsection*{4.6. Random Allocation in the Delivery Room}","confidence":1,"confidence_rate":1},{"cnt":[[168,791],[1876,791],[1876,840],[168,840]],"region":{"top_left_x":167,"top_left_y":790,"width":1709,"height":51},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1566cb2ce7e144d59bde445932551a64","type":"text","conversion_output":true,"text":"Following informed consent, the mechanics of the randomization maneuver in the DR addresses the","text_display":"\n\nFollowing informed consent, the mechanics of the randomization maneuver in the DR addresses the","confidence":1,"confidence_rate":1},{"cnt":[[168,846],[483,846],[483,898],[168,898]],"region":{"top_left_x":167,"top_left_y":846,"width":317,"height":53},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d402527bfe9f4825b2dd3610a0b886c1","type":"text","conversion_output":true,"text":"following aspects:","text_display":" following aspects:","confidence":1,"confidence_rate":1},{"cnt":[[232,920],[1549,920],[1549,969],[232,969]],"region":{"top_left_x":232,"top_left_y":919,"width":1318,"height":50},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e5ab36ca39d84202bd2362265f028b5b","type":"text","conversion_output":true,"text":"- Twins and multiples will be randomized as a unit, using a single envelope.","text_display":"\n- Twins and multiples will be randomized as a unit, using a single envelope.","confidence":0.98486328125,"confidence_rate":0.9998117158979831},{"cnt":[[232,1014],[1794,1014],[1794,1063],[232,1063]],"region":{"top_left_x":232,"top_left_y":1014,"width":1562,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d1ab53cc0a864b01ad27aa17b3d81ed6","type":"text","conversion_output":true,"text":"- Envelopes will be kept immediately outside the DR, at a safe designated site suitable for","text_display":"\n- Envelopes will be kept immediately outside the DR, at a safe designated site suitable for","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[294,1074],[466,1074],[466,1119],[294,1119]],"region":{"top_left_x":294,"top_left_y":1074,"width":173,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5059b0cbe58347109a137f405d0d96f4","type":"text","conversion_output":true,"text":"each site.","text_display":" each site.","confidence":1,"confidence_rate":1},{"cnt":[[168,1164],[1869,1164],[1869,1216],[168,1216]],"region":{"top_left_x":167,"top_left_y":1164,"width":1703,"height":53},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6a1f700ea96426b8f589a9abf9bc01d","type":"text","conversion_output":true,"text":"There will be between 3-5 envelopes for each of the gestational age strata in each location. This will","text_display":"\n\nThere will be between 3-5 envelopes for each of the gestational age strata in each location. This will","confidence":0.984870433807373,"confidence_rate":0.9998575317781223},{"cnt":[[168,1225],[1798,1225],[1798,1276],[168,1276]],"region":{"top_left_x":167,"top_left_y":1224,"width":1632,"height":53},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56caaf9012ff414e8bb2be818c3bd6f5","type":"text","conversion_output":true,"text":"ensure that in the hurry around a pending delivery there is no excess fumbling. Selection will be","text_display":" ensure that in the hurry around a pending delivery there is no excess fumbling. Selection will be","confidence":1,"confidence_rate":1},{"cnt":[[168,1285],[1420,1285],[1420,1334],[168,1334]],"region":{"top_left_x":167,"top_left_y":1284,"width":1254,"height":51},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1d7cc20c5b5640d68dd239cbf0fa72b0","type":"text","conversion_output":true,"text":"sequential and the lowest number marked on the envelope will be taken.","text_display":" sequential and the lowest number marked on the envelope will be taken.","confidence":1,"confidence_rate":1},{"cnt":[[168,1375],[1923,1375],[1923,1429],[168,1429]],"region":{"top_left_x":167,"top_left_y":1375,"width":1756,"height":54},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"699f9fe4ecd948b8b20ffc4c9a5b4402","type":"text","conversion_output":true,"text":"The next numbered envelope will be taken into the DR by the NICU-DR team. Opening of the envelope,","text_display":"\n\nThe next numbered envelope will be taken into the DR by the NICU-DR team. Opening of the envelope,","confidence":1,"confidence_rate":1},{"cnt":[[168,1435],[1863,1435],[1863,1485],[168,1485]],"region":{"top_left_x":167,"top_left_y":1435,"width":1696,"height":50},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"de19b0f2c5da40f88a53e811e4d1562b","type":"text","conversion_output":true,"text":"and thus randomization, will only be performed when the infant has been delivered and deemed to","text_display":" and thus randomization, will only be performed when the infant has been delivered and deemed to","confidence":1,"confidence_rate":1},{"cnt":[[168,1495],[1846,1495],[1846,1545],[168,1545]],"region":{"top_left_x":167,"top_left_y":1495,"width":1679,"height":50},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f657bd4e3401440886d6e9dcbbc2a2e9","type":"text","conversion_output":true,"text":"require respiratory assistance. Within 15-30 seconds the assessment of whether or not the baby is","text_display":" require respiratory assistance. Within 15-30 seconds the assessment of whether or not the baby is","confidence":0.7216796875,"confidence_rate":0.99680732428015},{"cnt":[[168,1551],[1242,1551],[1242,1603],[168,1603]],"region":{"top_left_x":167,"top_left_y":1551,"width":1075,"height":52},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6941dda5223e4c5dba6ed97ef36ed9a5","type":"text","conversion_output":true,"text":"eligible to be randomized is possible to make in a safe manner.","text_display":" eligible to be randomized is possible to make in a safe manner.","confidence":1,"confidence_rate":1},{"cnt":[[168,1646],[1914,1646],[1914,1695],[168,1695]],"region":{"top_left_x":167,"top_left_y":1645,"width":1748,"height":51},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"31da6b9c22ba438ea3c6b2dca1503278","type":"text","conversion_output":true,"text":"We have undertaken extensive simulation of this procedure and it does not introduce time-delays. We","text_display":"\n\nWe have undertaken extensive simulation of this procedure and it does not introduce time-delays. We","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[168,1706],[1910,1706],[1910,1755],[168,1755]],"region":{"top_left_x":167,"top_left_y":1705,"width":1743,"height":51},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e784617d9b164786ae2fa6aa33ae0fe1","type":"text","conversion_output":true,"text":"provide here a video clip showing this procedure in action at one of these simulations on the SAIL Trial","text_display":" provide here a video clip showing this procedure in action at one of these simulations on the SAIL Trial","confidence":1,"confidence_rate":1},{"cnt":[[168,1762],[1931,1762],[1931,1811],[168,1811]],"region":{"top_left_x":167,"top_left_y":1761,"width":1765,"height":51},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4905177954734641bbd2cffe0a85ab5f","type":"text","conversion_output":true,"text":"website. Our peocedure is modeled on those undertaken during the pivotal COIN trial where a member","text_display":" website. Our peocedure is modeled on those undertaken during the pivotal COIN trial where a member","confidence":1,"confidence_rate":1},{"cnt":[[168,1822],[1914,1822],[1914,1871],[168,1871]],"region":{"top_left_x":167,"top_left_y":1821,"width":1748,"height":51},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a3ebe3b591834e029279243a2ea5fc6b","type":"text","conversion_output":true,"text":"of our Steering Committee (P.Davis Melbourne) was a co-investigator. In addition Dr Kirpalani was one","text_display":" of our Steering Committee (P.Davis Melbourne) was a co-investigator. In addition Dr Kirpalani was one","confidence":0.990234375,"confidence_rate":0.9999074229511014},{"cnt":[[168,1878],[1807,1878],[1807,1929],[168,1929]],"region":{"top_left_x":167,"top_left_y":1877,"width":1640,"height":53},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"475cf5d2f51d47ba913949e994d2bc7c","type":"text","conversion_output":true,"text":"of the site investigators for the COIN trial at McMaster University, Canada, where the process of","text_display":" of the site investigators for the COIN trial at McMaster University, Canada, where the process of","confidence":1,"confidence_rate":1},{"cnt":[[168,1938],[1188,1938],[1188,1987],[168,1987]],"region":{"top_left_x":167,"top_left_y":1937,"width":1022,"height":51},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"262486c3eeb049e2abe46f4113e20131","type":"text","conversion_output":true,"text":"randomization also did not impede safe practices in the DR.","text_display":" randomization also did not impede safe practices in the DR.","confidence":1,"confidence_rate":1},{"cnt":[[168,2032],[1893,2032],[1893,2082],[168,2082]],"region":{"top_left_x":167,"top_left_y":2032,"width":1726,"height":50},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea30a2d9f27f40b69cf765cb3c7bc767","type":"text","conversion_output":true,"text":"Thus opening of the envelope will not impede appropriate delivery of care. All opened envelopes and","text_display":"\n\nThus opening of the envelope will not impede appropriate delivery of care. All opened envelopes and","confidence":0.998046875,"confidence_rate":0.9999812017648063},{"cnt":[[168,2088],[1863,2088],[1863,2140],[168,2140]],"region":{"top_left_x":167,"top_left_y":2088,"width":1696,"height":52},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d201c60b280a45ac8b062b2cc848636a","type":"text","conversion_output":true,"text":"assignments will be kept in the logs of the site. The research study coordinator will be available as a","text_display":" assignments will be kept in the logs of the site. 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Study Data","text_display":"\n\n\\section*{5. Study Data}","confidence":1,"confidence_rate":1},{"cnt":[[168,262],[1910,262],[1910,316],[168,316]],"region":{"top_left_x":167,"top_left_y":262,"width":1743,"height":54},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d93e60fe9704d1d865aadfda1fbea84","type":"text","conversion_output":true,"text":"The following is a table of details that will be collected, and it is itemized by day of collection. It should","text_display":"\n\nThe following is a table of details that will be collected, and it is itemized by day of collection. 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Data Collection Topic & Specific Data Elements & Specific time interval \\\\\n\\hline Eligibility and Randomization Data Form & \\begin{tabular}{l}\nClinical data: meets inclusion criteria and none of exclusion criteria; eligibility confirmed \\\\\nResearch: date and time of randomization, and allocation of treatment arm (control vs intervention)\n\\end{tabular} & First 30 seconds of birth \\\\\n\\hline \\multirow[t]{2}{*}{Delivery Room (DR) Data Form} & RESEARCH DATA collected: time infant is placed on resuscitation trolley; time of specific maneuver; \\(1^{\\text {st }}\\) sustained inflation and exact pressure measurement x 15 seconds; time of \\(2^{\\text {nd }}\\) sustained inflation and exact pressure measurement x 15 seconds; and use of ventilator vs T-piece & Research intervention takes place within the first 30 seconds up to 1-2 minutes of life \\\\\n\\hline & \\begin{tabular}{l}\nClinical data: time of birth, time of cord clamping, NRP guidelines used in the resuscitation of the infant such as respiratory status; blood gas values including glucose and hemoglobin/hematocrit values; procedures if any (intubation, chest compression, administration of epinephrine; surfactant delivery; UAC/UVC placement; chest tube placement and additional medications; final respiratory status before leaving DR; and outcome of resuscitation. \\\\\nAdditional clinical information: date and time of birth, birth weight, Apgar score at 1 and 5 min , and gender\n\\end{tabular} & Certain clinical time points as dictated by the resuscitation process in the DR; data should be completed within first 48 hours \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline Data Collection Topic & Specific Data Elements & Specific time interval \\\\\n\\hline Eligibility and Randomization Data Form & \\begin{tabular}{l}\nClinical data: meets inclusion criteria and none of exclusion criteria; eligibility confirmed \\\\\nResearch: date and time of randomization, and 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Data Collection Topic & Specific Data Elements & Specific time interval \\\\\n\\hline Daily Assessment for First Week of Life & \\begin{tabular}{l}\nClinical: birth weight and head circumference; antibiotics, antifungals, indomethacin or ibuprofen, caffeine or other methylxanthines; furosemide or other loop diuretic; thiazide diuretic; corticosteroids, inhaled corticosteroids, inhaled nitric oxide, inhaled bronchodilator; vitamin A IM, erythropoietin; red blood cell transfusion, any paralytic agent; any anticonvulsants, any milk feed or formula, any breast feeding and any parental nutrition \\\\\nClinical radiographic data, if available: head ultrasound or MRI, number of CXR, abdominal films\n\\end{tabular} & Completed for every day for the first week of life \\\\\n\\hline Maternal Data Form & Clinical: mother's age, gravid para status, exposure to antenatal steroids and type; maternal ethnicity; maternal education, any medications given to prolong pregnancy including tocolytics; placental abruption; chorioamnionitis; membranes rupture \\(\\geq 24\\) hours before delivery; mode of delivery & Completed within one week of enrollment \\\\\n\\hline Weekly Respiratory Status until 36 wks PMA & \\begin{tabular}{l}\nClinical: current respiratory status at noon once/week to include if applicable, respiratory support (CPAP, noninvasive PPV, invasive PPV); specific ventilatory settings \\\\\nInfant's respiratory rate, highest \\(FiO _{2}\\) from previous time point and corresponding SpO2\n\\end{tabular} & Collected weekly from \\(2^{\\text {nd }}\\) week of life until 36 weeks PMA \\\\\n\\hline Weekly Assessment until 36 wks PMA & Same as above with the exception of weekly head circumference instead of at birth and date of successful extubation defined as extubation for greater than 48 hours & Can be completed once a week (does not need to be a specific day of the week) \\\\\n\\hline Respiratory Status at 36 wks PMA & \\begin{tabular}{l}\nClinical data: exact 36 wks PMA date; respiratory status (RA, NC, CPAP, invasive/non-invasive PPV), \\\\\nIf applicable pass/fail Oxygen Reduction Test (ORT)\n\\end{tabular} & Can be completed within one week of reaching 36 wks PMA \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline Data Collection Topic & Specific Data Elements & Specific time interval \\\\\n\\hline Daily Assessment for First Week of Life & \\begin{tabular}{l}\nClinical: birth weight and head circumference; antibiotics, antifungals, indomethacin or ibuprofen, caffeine or other methylxanthines; furosemide or other loop diuretic; thiazide diuretic; corticosteroids, inhaled corticosteroids, inhaled nitric oxide, inhaled bronchodilator; vitamin A IM, erythropoietin; red blood cell transfusion, any paralytic agent; any anticonvulsants, any milk feed or formula, any breast feeding and any parental nutrition \\\\\nClinical radiographic data, if available: head ultrasound or MRI, number of CXR, abdominal films\n\\end{tabular} & Completed for every day for the first week of life \\\\\n\\hline Maternal Data Form & Clinical: mother's age, gravid para status, exposure to antenatal steroids and type; maternal ethnicity; maternal education, any medications given to prolong pregnancy including tocolytics; placental abruption; chorioamnionitis; membranes rupture \\(\\geq 24\\) hours before delivery; mode of delivery & Completed within one week of enrollment \\\\\n\\hline Weekly Respiratory Status until 36 wks PMA & \\begin{tabular}{l}\nClinical: current respiratory status at noon once/week to include if applicable, respiratory support (CPAP, noninvasive PPV, invasive PPV); specific ventilatory settings \\\\\nInfant's respiratory rate, highest \\(FiO _{2}\\) from previous time point and corresponding SpO2\n\\end{tabular} & Collected weekly from \\(2^{\\text {nd }}\\) week of life until 36 weeks PMA \\\\\n\\hline Weekly Assessment until 36 wks PMA & Same as above with the exception of weekly head circumference instead of at birth and date of successful extubation defined as extubation for greater than 48 hours & Can be completed once a week (does not need to be a specific day of the week) \\\\\n\\hline Respiratory Status at 36 wks PMA & \\begin{tabular}{l}\nClinical data: exact 36 wks PMA date; respiratory status (RA, NC, CPAP, invasive/non-invasive PPV), \\\\\nIf applicable pass/fail Oxygen Reduction Test (ORT)\n\\end{tabular} & Can be completed within one week of reaching 36 wks PMA 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antibiotics, antifungals, indomethacin or ibuprofen, caffeine or other methylxanthines; furosemide or other loop diuretic; thiazide diuretic; corticosteroids, inhaled corticosteroids, inhaled nitric oxide, inhaled bronchodilator; vitamin A IM, erythropoietin; red blood cell transfusion, any paralytic agent; any anticonvulsants, any milk feed or formula, any breast feeding and any parental nutrition \\\\\nClinical radiographic data, if available: head ultrasound or MRI, number of CXR, abdominal films\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nClinical: birth weight and head circumference; antibiotics, antifungals, indomethacin or ibuprofen, caffeine or other methylxanthines; furosemide or other loop diuretic; thiazide diuretic; corticosteroids, inhaled corticosteroids, inhaled nitric oxide, inhaled bronchodilator; vitamin A IM, erythropoietin; red blood cell transfusion, any paralytic agent; any anticonvulsants, any milk feed or formula, any breast feeding and any parental 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In","confidence":0.9985356330871582,"confidence_rate":0.9999859093286404},{"cnt":[[230,1113],[1929,1113],[1929,1167],[230,1167]],"region":{"top_left_x":229,"top_left_y":1112,"width":1701,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57a2c2e3c2674c6e895523aef2426ad8","type":"text","conversion_output":true,"text":"general, after initial resuscitation, CPAP will be the initial mode of respiratory support in reasonably","text_display":" general, after initial resuscitation, CPAP will be the initial mode of respiratory support in reasonably","confidence":1,"confidence_rate":1},{"cnt":[[230,1173],[1895,1173],[1895,1222],[230,1222]],"region":{"top_left_x":229,"top_left_y":1173,"width":1666,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99a459af49ae4524af0c523ce86114df","type":"text","conversion_output":true,"text":"vigorous infants. Intubation will be reserved for infants who remain apneic, are without adequate","text_display":" vigorous infants. Intubation will be reserved for infants who remain apneic, are without adequate","confidence":1,"confidence_rate":1},{"cnt":[[232,1231],[1936,1231],[1936,1283],[232,1283]],"region":{"top_left_x":232,"top_left_y":1231,"width":1704,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52ba161500e2440791a7a3d45b746cbc","type":"text","conversion_output":true,"text":"respiratory effort, or have persistent bradycardia. Surfactant for RDS prophylaxis will not be given in","text_display":" respiratory effort, or have persistent bradycardia. Surfactant for RDS prophylaxis will not be given in","confidence":0.998046875,"confidence_rate":0.9999818979894378},{"cnt":[[230,1289],[1931,1289],[1931,1343],[230,1343]],"region":{"top_left_x":229,"top_left_y":1289,"width":1703,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"434ce9f52ff54a6e93b0f52398cbeb44","type":"text","conversion_output":true,"text":"the DR prior to SI (if so randomized), even if the infant is intubated. Caffeine will be administered to","text_display":" the DR prior to SI (if so randomized), even if the infant is intubated. Caffeine will be administered to","confidence":0.9248411655426025,"confidence_rate":0.9992834378704063},{"cnt":[[232,1349],[935,1349],[935,1399],[232,1399]],"region":{"top_left_x":232,"top_left_y":1349,"width":703,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5630b9f69c8f4d909ccf05d4665485a1","type":"text","conversion_output":true,"text":"infants if needed for respiratory support.","text_display":" infants if needed for respiratory support.","confidence":1,"confidence_rate":1},{"cnt":[[232,1439],[1944,1439],[1944,1493],[232,1493]],"region":{"top_left_x":232,"top_left_y":1439,"width":1713,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d34970300fcc40f38d4f1c3e3179b69b","type":"text","conversion_output":true,"text":"Extubation and intubation guidelines: Continued need for mechanical ventilation is associated with","text_display":"\n\nExtubation and intubation guidelines: Continued need for mechanical ventilation is associated with","confidence":1,"confidence_rate":1},{"cnt":[[232,1500],[1938,1500],[1938,1551],[232,1551]],"region":{"top_left_x":232,"top_left_y":1499,"width":1706,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b9a05fbd6b14db2a9041a57f018b3e4","type":"text","conversion_output":true,"text":"BPD. We adopt a uniform guideline to intubation and extubation, though clinical circumstances may","text_display":" BPD. We adopt a uniform guideline to intubation and extubation, though clinical circumstances may","confidence":1,"confidence_rate":1},{"cnt":[[232,1558],[1876,1558],[1876,1609],[232,1609]],"region":{"top_left_x":232,"top_left_y":1557,"width":1644,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7442004de90d457ea95cfb420c0e2461","type":"text","conversion_output":true,"text":"preclude strict adherence to guidelines at all times. There is no consensus about weaning babies","text_display":" preclude strict adherence to guidelines at all times. There is no consensus about weaning babies","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[232,1618],[1944,1618],[1944,1669],[232,1669]],"region":{"top_left_x":232,"top_left_y":1617,"width":1713,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"076aa2572c4f4421be101baa465f3f5a","type":"text","conversion_output":true,"text":"from mechanical ventilation. Therefore, the proposed extubation guidelines are based on consensus","text_display":" from mechanical ventilation. Therefore, the proposed extubation guidelines are based on consensus","confidence":1,"confidence_rate":1},{"cnt":[[232,1676],[1914,1676],[1914,1727],[232,1727]],"region":{"top_left_x":232,"top_left_y":1675,"width":1683,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01d4e63094a54cfb86ff1cdc36d8e194","type":"text","conversion_output":true,"text":"and criteria used in several current and recent large clinical trials. On a daily basis the infant will be","text_display":" and criteria used in several current and recent large clinical trials. On a daily basis the infant will be","confidence":1,"confidence_rate":1},{"cnt":[[232,1732],[1953,1732],[1953,1785],[232,1785]],"region":{"top_left_x":232,"top_left_y":1731,"width":1721,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1b1f557920d44fab59dd11eec7588ac","type":"text","conversion_output":true,"text":"assessed for ability to wean from ventilation. We will strongly encourage extubation to be attempted","text_display":" assessed for ability to wean from ventilation. We will strongly encourage extubation to be attempted","confidence":1,"confidence_rate":1},{"cnt":[[232,1792],[1923,1792],[1923,1846],[232,1846]],"region":{"top_left_x":232,"top_left_y":1791,"width":1691,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fee45a6627f043f991778d8592f798f7","type":"text","conversion_output":true,"text":"within 24 hours after meeting all following criteria: \\(PCO _{2} \\leq 55 mm Hg\\) and a \\(pH \\geq 7.25, FiO _{2}\\) of \\(\\leq 0.4\\)","text_display":" within 24 hours after meeting all following criteria: \\(PCO _{2} \\leq 55 mm Hg\\) and a \\(pH \\geq 7.25, FiO _{2}\\) of \\(\\leq 0.4\\)","confidence":0.9653806686401367,"confidence_rate":0.9997331206174783},{"cnt":[[232,1852],[1843,1852],[1843,1904],[232,1904]],"region":{"top_left_x":232,"top_left_y":1851,"width":1612,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c2702a879b934c539680094ae6cc8b12","type":"text","conversion_output":true,"text":"with an \\(SpO _{2}\\) of \\(\\geq 88 \\%\\) or higher, mean airway pressure of \\(\\leq 8 cm\\) of water, and hemodynamic","text_display":" with an \\(SpO _{2}\\) of \\(\\geq 88 \\%\\) or higher, mean airway pressure of \\(\\leq 8 cm\\) of water, and hemodynamic","confidence":1,"confidence_rate":1},{"cnt":[[232,1908],[1914,1908],[1914,1962],[232,1962]],"region":{"top_left_x":232,"top_left_y":1907,"width":1683,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d77b9f3e77c84ff5bc98f9136e547ebe","type":"text","conversion_output":true,"text":"stability and without evidence of clinically significant patent ductus arteriosus. All infants will have","text_display":" stability and without evidence of clinically significant patent ductus arteriosus. All infants will have","confidence":1,"confidence_rate":1},{"cnt":[[232,1968],[1936,1968],[1936,2020],[232,2020]],"region":{"top_left_x":232,"top_left_y":1967,"width":1704,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a697ffe57c54a67ab37be1d97924c1c","type":"text","conversion_output":true,"text":"received caffeine prior to an extubation attempt. Extubation may be attempted at higher settings at","text_display":" received caffeine prior to an extubation attempt. Extubation may be attempted at higher settings at","confidence":1,"confidence_rate":1},{"cnt":[[230,2024],[1953,2024],[1953,2078],[230,2078]],"region":{"top_left_x":229,"top_left_y":2023,"width":1724,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3386ca36fec04980959f6a5e9958ca18","type":"text","conversion_output":true,"text":"the discretion of the clinical team. Following extubation all infants should be placed on nasal CPAP or","text_display":" the discretion of the clinical team. Following extubation all infants should be placed on nasal CPAP or","confidence":1,"confidence_rate":1},{"cnt":[[232,2084],[1824,2084],[1824,2136],[232,2136]],"region":{"top_left_x":232,"top_left_y":2083,"width":1593,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9b7909e0af9b4ad0ac4dd95e755747fa","type":"text","conversion_output":true,"text":"NIPPV, not on nasal cannula or oxihood. In unplanned extubations, the infant will be given an","text_display":" NIPPV, not on nasal cannula or oxihood. In unplanned extubations, the infant will be given an","confidence":1,"confidence_rate":1},{"cnt":[[232,2144],[1841,2144],[1841,2194],[232,2194]],"region":{"top_left_x":232,"top_left_y":2144,"width":1610,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45253f602ee84ffa9a2c79a0f59ed2c7","type":"text","conversion_output":true,"text":"opportunity to remain extubated, if heart rate and oxygen saturations are maintained without","text_display":" opportunity to remain extubated, if heart rate and oxygen saturations are maintained without","confidence":1,"confidence_rate":1},{"cnt":[[232,2202],[1865,2202],[1865,2254],[232,2254]],"region":{"top_left_x":232,"top_left_y":2202,"width":1633,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"110d9a608ca8450a9c42f35172bdefab","type":"text","conversion_output":true,"text":"excessively high \\(FiO _{2}\\) or work of breathing. Extubation will be considered successful if the infant","text_display":" excessively high \\(FiO _{2}\\) or work of breathing. Extubation will be considered successful if the infant","confidence":1,"confidence_rate":1},{"cnt":[[232,2260],[1893,2260],[1893,2310],[232,2310]],"region":{"top_left_x":232,"top_left_y":2260,"width":1661,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5891947c1d1a40afb29061d079429374","type":"text","conversion_output":true,"text":"remains extubated for at least 48 hours. Reintubation will be at the discretion of the clinical team","text_display":" remains extubated for at least 48 hours. Reintubation will be at the discretion of the clinical team","confidence":1,"confidence_rate":1},{"cnt":[[232,2320],[595,2320],[595,2370],[232,2370]],"region":{"top_left_x":232,"top_left_y":2320,"width":364,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf1f24aee6504e7e93e33aa1c3a89002","type":"text","conversion_output":true,"text":"managing the infant.","text_display":" managing the infant.","confidence":1,"confidence_rate":1},{"cnt":[[232,2411],[1953,2411],[1953,2464],[232,2464]],"region":{"top_left_x":232,"top_left_y":2410,"width":1721,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"06fb5f3e9db54af4825751b0ac9191e9","type":"text","conversion_output":true,"text":"Demographic variables: The next section describes the analytical plan to examine the key covariates","text_display":"\n\nDemographic variables: The next section describes the analytical plan to examine the key covariates","confidence":1,"confidence_rate":1},{"cnt":[[232,2462],[1463,2462],[1463,2522],[232,2522]],"region":{"top_left_x":232,"top_left_y":2462,"width":1232,"height":61},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"341934b73c7d4b7faf083eda8f10b45f","type":"text","conversion_output":true,"text":"of gender, antenatal corticosteroids, multiples, and week of gestation. \\({ }^{19}\\)","text_display":" of gender, antenatal corticosteroids, multiples, and week of gestation. \\({ }^{19}\\)","confidence":1,"confidence_rate":1},{"cnt":[[1904,2643],[1959,2643],[1959,2696],[1904,2696]],"region":{"top_left_x":1903,"top_left_y":2642,"width":57,"height":55},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2695f21bb1a4f1e9f91d48e41238cf4","type":"page_info","conversion_output":false,"text":"30","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-31","page":31,"lines":[{"cnt":[[168,62],[1222,62],[1222,116],[168,116]],"region":{"top_left_x":167,"top_left_y":62,"width":1056,"height":55},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f0eb7d71fe04b09bbd4fc719da072b1","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) Study","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1495,64],[1914,64],[1914,114],[1495,114]],"region":{"top_left_x":1495,"top_left_y":64,"width":420,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30152aa96fa64115bf11471a9a4f0a8f","type":"page_info","conversion_output":false,"text":"Version 2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[232,180],[1901,180],[1901,228],[232,228]],"region":{"top_left_x":232,"top_left_y":180,"width":1670,"height":48},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d425cafe9a824fcd9f46a251640ab454","type":"text","conversion_output":true,"text":"All of these instructions and definitions will be written into an Operating Manual to be used as the","text_display":"\n\nAll of these instructions and definitions will be written into an Operating Manual to be used as the","confidence":1,"confidence_rate":1},{"cnt":[[232,236],[1485,236],[1485,286],[232,286]],"region":{"top_left_x":232,"top_left_y":236,"width":1253,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2740b38537c74eedbeba9c86be449adf","type":"text","conversion_output":true,"text":"initial source for teaching sites and their staff, and on-going re-education.","text_display":" initial source for teaching sites and their staff, and on-going re-education.","confidence":0.99951171875,"confidence_rate":0.9999940439141021},{"cnt":[[168,352],[728,352],[728,421],[168,421]],"region":{"top_left_x":167,"top_left_y":352,"width":562,"height":70},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2acda068b7f346aaafe0cb98d16a6e53","type":"section_header","conversion_output":false,"children_ids":["c8f7dcf0b8804aa8a8914df8b050d4df"],"text":"","text_display":""},{"cnt":[[172,361],[724,361],[724,415],[172,415]],"region":{"top_left_x":171,"top_left_y":360,"width":554,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c8f7dcf0b8804aa8a8914df8b050d4df","type":"text","conversion_output":true,"parent_id":"2acda068b7f346aaafe0cb98d16a6e53","text":"6. Statistical Analysis","text_display":"\n\n\\section*{6. Statistical Analysis}","confidence":1,"confidence_rate":1},{"cnt":[[168,447],[1899,447],[1899,492],[168,492]],"region":{"top_left_x":167,"top_left_y":446,"width":1733,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"836ac0b675bb4f98adf503dea0b07817","type":"text","conversion_output":true,"text":"The Data Coordinating Center (DCC) will be housed at the University of Pennslyvania and submitting a","text_display":"\n\nThe Data Coordinating Center (DCC) will be housed at the University of Pennslyvania and submitting a","confidence":0.9980475902557373,"confidence_rate":0.9999813876191115},{"cnt":[[172,505],[1835,505],[1835,552],[172,552]],"region":{"top_left_x":171,"top_left_y":504,"width":1664,"height":49},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2b51321784f413ca092250f53eba039","type":"text","conversion_output":true,"text":"separate IRB approval request to the IRB. The DCC is comprised of four parts: Biostatistics, Project","text_display":" separate IRB approval request to the IRB. The DCC is comprised of four parts: Biostatistics, Project","confidence":1,"confidence_rate":1},{"cnt":[[172,563],[1192,563],[1192,610],[172,610]],"region":{"top_left_x":171,"top_left_y":562,"width":1022,"height":49},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1f517b10fd44ec69690ae6129d32ad0","type":"text","conversion_output":true,"text":"Management, Data Management and Research Technology.","text_display":" Management, Data Management and Research Technology.","confidence":0.99853515625,"confidence_rate":0.9999742824766222},{"cnt":[[172,657],[1914,657],[1914,703],[172,703]],"region":{"top_left_x":171,"top_left_y":657,"width":1744,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03eccce453134aee8bd3cee34fde7cf8","type":"text","conversion_output":true,"text":"Biostatistical support will provide centralized randomization, publication support, interim analyses and","text_display":"\n\nBiostatistical support will provide centralized randomization, publication support, interim analyses and","confidence":1,"confidence_rate":1},{"cnt":[[172,713],[1828,713],[1828,763],[172,763]],"region":{"top_left_x":171,"top_left_y":713,"width":1658,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"640fbde6a8c14eaca40ebccb188575b4","type":"text","conversion_output":true,"text":"statistical analysis plans under the direction of Drs. Ratcliffe and Localio. Project management will","text_display":" statistical analysis plans under the direction of Drs. Ratcliffe and Localio. Project management will","confidence":1,"confidence_rate":1},{"cnt":[[172,773],[1927,773],[1927,821],[172,821]],"region":{"top_left_x":171,"top_left_y":773,"width":1757,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"909d98e379c742fb90d1a677b6c89583","type":"text","conversion_output":true,"text":"coordinate activities between the scientific and operations teams and manage sites. Data Management","text_display":" coordinate activities between the scientific and operations teams and manage sites. 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Sample Size Determination}","confidence":1,"confidence_rate":1},{"cnt":[[232,1139],[1929,1139],[1929,1184],[232,1184]],"region":{"top_left_x":232,"top_left_y":1138,"width":1698,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85ed0fb656c244ac92a3d9eddba31a70","type":"text","conversion_output":true,"text":"Sample size is based on a possible reduction in risk of neonatal mortality/BDP in infants at 36 weeks","text_display":"\n\nSample size is based on a possible reduction in risk of neonatal mortality/BDP in infants at 36 weeks","confidence":1,"confidence_rate":1},{"cnt":[[232,1197],[1863,1197],[1863,1244],[232,1244]],"region":{"top_left_x":232,"top_left_y":1196,"width":1631,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0f5b0e6669a49e7a8d0ff77d28d7410","type":"text","conversion_output":true,"text":"PMA receiving the SI intervention compared to those who receive the standard PEEP/CPAP. The","text_display":" PMA receiving the SI intervention compared to those who receive the standard PEEP/CPAP. The","confidence":0.9975600242614746,"confidence_rate":0.9999745528515933},{"cnt":[[232,1255],[1852,1255],[1852,1304],[232,1304]],"region":{"top_left_x":232,"top_left_y":1254,"width":1620,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1983977efaae4802920c7ad153e40746","type":"text","conversion_output":true,"text":"significance level was set at \\(\\alpha=0.038\\) (due to the interim analyses), and power at \\(80 \\%\\). Based on","text_display":" significance level was set at \\(\\alpha=0.038\\) (due to the interim analyses), and power at \\(80 \\%\\). Based on","confidence":1,"confidence_rate":1},{"cnt":[[232,1306],[1893,1306],[1893,1360],[232,1360]],"region":{"top_left_x":232,"top_left_y":1306,"width":1661,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20e05b02329b43c5b59ad8f44d91ac60","type":"text","conversion_output":true,"text":"information from the recent multi-center NICHD SUPPORT trial \\({ }^{2}\\) and the COIN trial, \\({ }^{20}\\) we estimate","text_display":" information from the recent multi-center NICHD SUPPORT trial \\({ }^{2}\\) and the COIN trial, \\({ }^{20}\\) we estimate","confidence":1,"confidence_rate":1},{"cnt":[[232,1371],[1944,1371],[1944,1420],[232,1420]],"region":{"top_left_x":232,"top_left_y":1370,"width":1713,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a29a1688ee849929c9bc3c8458fae4e","type":"text","conversion_output":true,"text":"that the baseline rate of neonatal mortality/BDP in the standard or care (control) arm by 36 weeks is","text_display":" that the baseline rate of neonatal mortality/BDP in the standard or care (control) arm by 36 weeks is","confidence":0.9882867336273193,"confidence_rate":0.9998919103639693},{"cnt":[[232,1431],[324,1431],[324,1472],[232,1472]],"region":{"top_left_x":232,"top_left_y":1430,"width":93,"height":42},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe7cdf6477ae4a769af1616b9d6d75fd","type":"text","conversion_output":true,"text":"\\(65 \\%\\).","text_display":" \\(65 \\%\\).","confidence":0.8260931968688965,"confidence_rate":0.9789961977212635},{"cnt":[[232,1523],[1934,1523],[1934,1571],[232,1571]],"region":{"top_left_x":232,"top_left_y":1523,"width":1702,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4b160694f5142888ad9e5240d2a59fb","type":"text","conversion_output":true,"text":"In order to detect an absolute risk reduction of \\(12.5 \\%, 263\\) subjects per treatment arm are required.","text_display":"\n\nIn order to detect an absolute risk reduction of \\(12.5 \\%, 263\\) subjects per treatment arm are required.","confidence":0.9541077613830566,"confidence_rate":0.9995610435052263},{"cnt":[[232,1581],[1854,1581],[1854,1631],[232,1631]],"region":{"top_left_x":232,"top_left_y":1581,"width":1623,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df8057f157da410784a1e6db9520b036","type":"text","conversion_output":true,"text":"We anticipate virtually no loss to follow-up for the primary endpoint as infants will likely still be","text_display":" We anticipate virtually no loss to follow-up for the primary endpoint as infants will likely still be","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[232,1641],[1951,1641],[1951,1687],[232,1687]],"region":{"top_left_x":232,"top_left_y":1641,"width":1719,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb44c76b024e40f2a24a0d112312ddd6","type":"text","conversion_output":true,"text":"hospitalized because of their condition, will be under constant and continuing medical care. We have","text_display":" hospitalized because of their condition, will be under constant and continuing medical care. We have","confidence":1,"confidence_rate":1},{"cnt":[[232,1697],[1914,1697],[1914,1747],[232,1747]],"region":{"top_left_x":232,"top_left_y":1697,"width":1683,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"140776809bf748fdb22f527f106c946e","type":"text","conversion_output":true,"text":"inflated the estimate by 1.12 to allow for twins and multiples to be randomized together. With this","text_display":" inflated the estimate by 1.12 to allow for twins and multiples to be randomized together. With this","confidence":1,"confidence_rate":1},{"cnt":[[232,1757],[1553,1757],[1553,1807],[232,1807]],"region":{"top_left_x":232,"top_left_y":1757,"width":1322,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6b70fe60353406a92e7b68a78e89778","type":"text","conversion_output":true,"text":"inflation in mind, the target sample size for this study is 300 subjects per arm.","text_display":" inflation in mind, the target sample size for this study is 300 subjects per arm.","confidence":1,"confidence_rate":1},{"cnt":[[232,1852],[1893,1852],[1893,1897],[232,1897]],"region":{"top_left_x":232,"top_left_y":1851,"width":1661,"height":47},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9bd309eb8e1840a6903f86fb66e8b648","type":"text","conversion_output":true,"text":"For the secondary outcomes available in all subjects, with 263 subjects per arm (ignoring the twin","text_display":"\n\nFor the secondary outcomes available in all subjects, with 263 subjects per arm (ignoring the twin","confidence":1,"confidence_rate":1},{"cnt":[[232,1910],[1934,1910],[1934,1957],[232,1957]],"region":{"top_left_x":232,"top_left_y":1909,"width":1702,"height":49},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b841d2a8442a4a3d9d3112930d901c23","type":"text","conversion_output":true,"text":"correction factor), there will be \\(80 \\%\\) power to detect a difference of 0.24 standard deviation units in","text_display":" correction factor), there will be \\(80 \\%\\) power to detect a difference of 0.24 standard deviation units in","confidence":0.9917216038018594,"confidence_rate":0.9999264376402397},{"cnt":[[232,1968],[1923,1968],[1923,2015],[232,2015]],"region":{"top_left_x":232,"top_left_y":1967,"width":1691,"height":49},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b36b2f3c2ec24cafb93e1beb78031b15","type":"text","conversion_output":true,"text":"continuous outcomes, and a hazard ratio of 0.77 in survival outcomes under a proportional hazards","text_display":" continuous outcomes, and a hazard ratio of 0.77 in survival outcomes under a proportional hazards","confidence":0.99560546875,"confidence_rate":0.9999580559693426},{"cnt":[[232,2028],[1893,2028],[1893,2073],[232,2073]],"region":{"top_left_x":232,"top_left_y":2028,"width":1661,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dcdced069c5a49ac9fa81d8a06fe5007","type":"text","conversion_output":true,"text":"assumption. Some secondary outcomes will not be available due to death of the infant, or loss to","text_display":" assumption. Some secondary outcomes will not be available due to death of the infant, or loss to","confidence":1,"confidence_rate":1},{"cnt":[[232,2084],[1953,2084],[1953,2133],[232,2133]],"region":{"top_left_x":232,"top_left_y":2083,"width":1721,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc99a85c66af4932a6ed6b8ce18174ee","type":"text","conversion_output":true,"text":"follow-up after discharge from the NICU. Overestimating these rates at \\(50 \\%\\), we assume 130 subjects","text_display":" follow-up after discharge from the NICU. Overestimating these rates at \\(50 \\%\\), we assume 130 subjects","confidence":0.92041015625,"confidence_rate":0.9992463215558628},{"cnt":[[232,2144],[1927,2144],[1927,2191],[232,2191]],"region":{"top_left_x":232,"top_left_y":2144,"width":1696,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bd0f9d5a5674826838638ef7a319c05","type":"text","conversion_output":true,"text":"per arm will be available for the longer term secondary outcomes. With this sample size we will still","text_display":" per arm will be available for the longer term secondary outcomes. With this sample size we will still","confidence":1,"confidence_rate":1},{"cnt":[[232,2202],[1897,2202],[1897,2249],[232,2249]],"region":{"top_left_x":232,"top_left_y":2202,"width":1666,"height":48},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93eac9443cd348c4b976d7bd2af70da1","type":"text","conversion_output":true,"text":"have sufficient power to detect a clinically meaningful difference of at least \\(17 \\%\\) in event rates (or","text_display":" have sufficient power to detect a clinically meaningful difference of at least \\(17 \\%\\) in event rates (or","confidence":0.8092391908221684,"confidence_rate":0.9980600424731639},{"cnt":[[232,2260],[672,2260],[672,2310],[232,2310]],"region":{"top_left_x":232,"top_left_y":2260,"width":441,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f7bba9545fd4ccba3cdd97937b515f3","type":"text","conversion_output":true,"text":"odds ratio of at least 2.0).","text_display":" odds ratio of at least 2.0).","confidence":0.99951171875,"confidence_rate":0.9999852000944255},{"cnt":[[163,2348],[662,2348],[662,2408],[163,2408]],"region":{"top_left_x":163,"top_left_y":2348,"width":499,"height":61},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41c3e79cd6cb462d885c74854d59ed0f","type":"section_header","conversion_output":false,"children_ids":["bb967dca6a324a9b98ea83a09fb52191"],"text":"","text_display":""},{"cnt":[[168,2355],[655,2355],[655,2402],[168,2402]],"region":{"top_left_x":167,"top_left_y":2354,"width":489,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb967dca6a324a9b98ea83a09fb52191","type":"text","conversion_output":true,"parent_id":"41c3e79cd6cb462d885c74854d59ed0f","text":"6.1.2. Methods of Analysis","text_display":"\n\n\\subsection*{6.1.2. Methods of Analysis}","confidence":0.86279296875,"confidence_rate":0.9952506522521761},{"cnt":[[232,2428],[1775,2428],[1775,2473],[232,2473]],"region":{"top_left_x":232,"top_left_y":2427,"width":1543,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50cac8eba2e44349ad7a28a6b8b502a0","type":"text","conversion_output":true,"text":"The proposed study is a two-arm parallel design of two alternative courses of treatment. A","text_display":"\n\nThe proposed study is a two-arm parallel design of two alternative courses of treatment. A","confidence":1,"confidence_rate":1},{"cnt":[[232,2484],[1901,2484],[1901,2533],[232,2533]],"region":{"top_left_x":232,"top_left_y":2483,"width":1670,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"727e1f36784946ddb64acb997d1882eb","type":"text","conversion_output":true,"text":"conventional \"as-randomized\" analysis (or \"intention-to-treat\" analysis) will estimate whether the","text_display":" conventional \"as-randomized\" analysis (or \"intention-to-treat\" analysis) will estimate whether the","confidence":1,"confidence_rate":1},{"cnt":[[1904,2643],[1955,2643],[1955,2696],[1904,2696]],"region":{"top_left_x":1903,"top_left_y":2642,"width":53,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de942e971c1249f68ff509f77f4b6230","type":"page_info","conversion_output":false,"text":"31","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-32","page":32,"lines":[{"cnt":[[168,64],[1218,64],[1218,114],[168,114]],"region":{"top_left_x":167,"top_left_y":64,"width":1052,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad92fa1371ba4bca84d104d353815007","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) Study","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1495,64],[1914,64],[1914,114],[1495,114]],"region":{"top_left_x":1495,"top_left_y":64,"width":420,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d03041460db4ed79d1c26778fb23020","type":"page_info","conversion_output":false,"text":"Version 2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[232,180],[1867,180],[1867,226],[232,226]],"region":{"top_left_x":232,"top_left_y":180,"width":1635,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"15eba5c21c034ed7ae9f4826f5c203c0","type":"text","conversion_output":true,"text":"experimental therapy is superior to conventional therapy in avoiding treatment failure, and is at","text_display":"\nexperimental therapy is superior to conventional therapy in avoiding treatment failure, and is at","confidence":1,"confidence_rate":1},{"cnt":[[232,236],[1345,236],[1345,286],[232,286]],"region":{"top_left_x":232,"top_left_y":236,"width":1113,"height":50},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9dea0081d06243fb9b597d010b62bcef","type":"text","conversion_output":true,"text":"least as good as conventional therapy in avoiding adverse events.","text_display":" least as good as conventional therapy in avoiding adverse events.","confidence":1,"confidence_rate":1},{"cnt":[[232,331],[1854,331],[1854,380],[232,380]],"region":{"top_left_x":232,"top_left_y":330,"width":1623,"height":51},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2368c13730294dbca9f4b6d26fc61911","type":"text","conversion_output":true,"text":"SAS will be used for secondary data management and descriptive statistics. SAS datasets will be","text_display":"\n\nSAS will be used for secondary data management and descriptive statistics. SAS datasets will be","confidence":0.9990234375,"confidence_rate":0.999990229651252},{"cnt":[[232,389],[1893,389],[1893,436],[232,436]],"region":{"top_left_x":232,"top_left_y":388,"width":1661,"height":49},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c5540f841669465394a83793cd381683","type":"text","conversion_output":true,"text":"downloaded at least weekly from the study database for analysis. Graphics will be prepared using","text_display":" downloaded at least weekly from the study database for analysis. Graphics will be prepared using","confidence":1,"confidence_rate":1},{"cnt":[[232,447],[1828,447],[1828,496],[232,496]],"region":{"top_left_x":232,"top_left_y":446,"width":1597,"height":51},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aadd0e7153934bf3b1a0e93729e2b285","type":"text","conversion_output":true,"text":"Stata v11 (or later) (Stata Corp, San Antonio TX, 2009) and the R programming package (The R","text_display":" Stata v11 (or later) (Stata Corp, San Antonio TX, 2009) and the R programming package (The R","confidence":1,"confidence_rate":1},{"cnt":[[234,507],[1904,507],[1904,554],[234,554]],"region":{"top_left_x":234,"top_left_y":507,"width":1670,"height":48},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"89ebdc427008471e9663daf39e1e3da9","type":"text","conversion_output":true,"text":"Foundation for Statistical Computing, Vienna, Austria, 2011). Analyses will be implemented in SAS.","text_display":" Foundation for Statistical Computing, Vienna, Austria, 2011). Analyses will be implemented in SAS.","confidence":1,"confidence_rate":1},{"cnt":[[165,595],[771,595],[771,655],[165,655]],"region":{"top_left_x":165,"top_left_y":595,"width":607,"height":61},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6e9b82366d24dd4b2d38f0a98122903","type":"section_header","conversion_output":false,"children_ids":["53f9d057273648bc9205868134365f8f"],"text":"","text_display":""},{"cnt":[[168,602],[767,602],[767,649],[168,649]],"region":{"top_left_x":167,"top_left_y":601,"width":600,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53f9d057273648bc9205868134365f8f","type":"text","conversion_output":true,"parent_id":"c6e9b82366d24dd4b2d38f0a98122903","text":"6.1.2.1. Descriptive Statistics","text_display":"\n\n\\subsection*{6.1.2.1. Descriptive Statistics}","confidence":0.99609375,"confidence_rate":0.9998912864841555},{"cnt":[[232,670],[1916,670],[1916,715],[232,715]],"region":{"top_left_x":232,"top_left_y":670,"width":1685,"height":46},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4c6376e6c28a40f48196ccbf1a03c76b","type":"text","conversion_output":true,"text":"Although randomization at baseline should balance observed and unobserved differences between","text_display":"\n\nAlthough randomization at baseline should balance observed and unobserved differences between","confidence":1,"confidence_rate":1},{"cnt":[[232,730],[1884,730],[1884,776],[232,776]],"region":{"top_left_x":232,"top_left_y":730,"width":1653,"height":46},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"18051fc5a68a4c3ab6c3f602cc91ede7","type":"text","conversion_output":true,"text":"the treatment arms by measured and unmeasured confounders, extra precautions are needed to","text_display":" the treatment arms by measured and unmeasured confounders, extra precautions are needed to","confidence":1,"confidence_rate":1},{"cnt":[[232,786],[1871,786],[1871,836],[232,836]],"region":{"top_left_x":232,"top_left_y":786,"width":1640,"height":50},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a9588e264e414526816f5df8f56a08aa","type":"text","conversion_output":true,"text":"guard against the potential bias of baseline covariates with chance imbalance from finite sample","text_display":" guard against the potential bias of baseline covariates with chance imbalance from finite sample","confidence":1,"confidence_rate":1},{"cnt":[[232,846],[1927,846],[1927,892],[232,892]],"region":{"top_left_x":232,"top_left_y":846,"width":1696,"height":46},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3335591a190449e78e66adc7abf8b83b","type":"text","conversion_output":true,"text":"sizes. Initial analysis will describe the distribution of data. We will characterize both treatment arms","text_display":" sizes. Initial analysis will describe the distribution of data. We will characterize both treatment arms","confidence":1,"confidence_rate":1},{"cnt":[[232,902],[1897,902],[1897,950],[232,950]],"region":{"top_left_x":232,"top_left_y":902,"width":1666,"height":48},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f27f2825b3d844bca832092553c33ac6","type":"text","conversion_output":true,"text":"by demographic variables and all covariates of interest. Means, standard deviations, medians, and","text_display":" by demographic variables and all covariates of interest. Means, standard deviations, medians, and","confidence":1,"confidence_rate":1},{"cnt":[[232,962],[1914,962],[1914,1010],[232,1010]],"region":{"top_left_x":232,"top_left_y":962,"width":1683,"height":48},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bdef2fd103754520b855c462039b56c0","type":"text","conversion_output":true,"text":"ranges will be computed for measured continuous variables; marginal distributions will be used for","text_display":" ranges will be computed for measured continuous variables; marginal distributions will be used for","confidence":1,"confidence_rate":1},{"cnt":[[232,1023],[1931,1023],[1931,1068],[232,1068]],"region":{"top_left_x":232,"top_left_y":1022,"width":1700,"height":46},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fe907cabd7a7437c8fd6db87593321c5","type":"text","conversion_output":true,"text":"categorical factors. Graphical methods including histograms, scatterplots, and boxplots, will be used","text_display":" categorical factors. Graphical methods including histograms, scatterplots, and boxplots, will be used","confidence":1,"confidence_rate":1},{"cnt":[[234,1079],[1794,1079],[1794,1128],[234,1128]],"region":{"top_left_x":234,"top_left_y":1078,"width":1560,"height":50},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3a33c2585a59408cac85aa8288260825","type":"text","conversion_output":true,"text":"in order to understand aspects of data quality and examine assumptions (such as normality)","text_display":" in order to understand aspects of data quality and examine assumptions (such as normality)","confidence":1,"confidence_rate":1},{"cnt":[[232,1139],[733,1139],[733,1184],[232,1184]],"region":{"top_left_x":232,"top_left_y":1138,"width":501,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0d944d773282405ea0f5d3cba27dffa5","type":"text","conversion_output":true,"text":"underlying statistical models.","text_display":" underlying statistical models.","confidence":1,"confidence_rate":1},{"cnt":[[168,1225],[926,1225],[926,1283],[168,1283]],"region":{"top_left_x":167,"top_left_y":1224,"width":759,"height":59},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e248ab86294f4b4d8ed6bd9bf3b5fd3c","type":"section_header","conversion_output":false,"children_ids":["d28f58a2866442289ef9529924c760b7"],"text":"","text_display":""},{"cnt":[[172,1229],[922,1229],[922,1278],[172,1278]],"region":{"top_left_x":171,"top_left_y":1228,"width":751,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d28f58a2866442289ef9529924c760b7","type":"text","conversion_output":true,"parent_id":"e248ab86294f4b4d8ed6bd9bf3b5fd3c","text":"6.1.2.2. Analysis of Primary Outcome","text_display":"\n\n\\subsection*{6.1.2.2. Analysis of Primary Outcome}","confidence":0.9716796875,"confidence_rate":0.9992995364528489},{"cnt":[[232,1302],[1854,1302],[1854,1347],[232,1347]],"region":{"top_left_x":232,"top_left_y":1301,"width":1623,"height":47},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8ac128a0cf65411fb80d69ac39298ca7","type":"text","conversion_output":true,"text":"The primary endpoint to be used for efficacy evaluation is the rate of Death or BPD at 36 weeks","text_display":"\n\nThe primary endpoint to be used for efficacy evaluation is the rate of Death or BPD at 36 weeks","confidence":1,"confidence_rate":1},{"cnt":[[232,1362],[1798,1362],[1798,1407],[232,1407]],"region":{"top_left_x":232,"top_left_y":1362,"width":1567,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"05b853b65fd64336883200ad963a5b22","type":"text","conversion_output":true,"text":"gestation age. The primary hypothesis to be tested is that the treatment therapy results in a","text_display":" gestation age. The primary hypothesis to be tested is that the treatment therapy results in a","confidence":1,"confidence_rate":1},{"cnt":[[232,1418],[1921,1418],[1921,1463],[232,1463]],"region":{"top_left_x":232,"top_left_y":1417,"width":1689,"height":47},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6649f43200ae47eaa8d4223249f8886f","type":"text","conversion_output":true,"text":"decreased event rate. Although a proportion's test is used for sample size calculations, rates will be","text_display":" decreased event rate. Although a proportion's test is used for sample size calculations, rates will be","confidence":1,"confidence_rate":1},{"cnt":[[232,1474],[1936,1474],[1936,1523],[232,1523]],"region":{"top_left_x":232,"top_left_y":1473,"width":1704,"height":51},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"44fc0268481948859d6fc815ffa22a57","type":"text","conversion_output":true,"text":"compared using logistic regression, which will allow for control of covariates, as well as investigation","text_display":" compared using logistic regression, which will allow for control of covariates, as well as investigation","confidence":1,"confidence_rate":1},{"cnt":[[232,1534],[1803,1534],[1803,1583],[232,1583]],"region":{"top_left_x":232,"top_left_y":1533,"width":1571,"height":51},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"859c9c2a01f64ef9af5e51a58dc481c9","type":"text","conversion_output":true,"text":"of effect modification. Potential covariates include gender, gestational age, initial heart rate,","text_display":" of effect modification. Potential covariates include gender, gestational age, initial heart rate,","confidence":1,"confidence_rate":1},{"cnt":[[232,1594],[1830,1594],[1830,1639],[232,1639]],"region":{"top_left_x":232,"top_left_y":1594,"width":1599,"height":46},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ad8f28cb1d8d425ca630a59bf727553b","type":"text","conversion_output":true,"text":"maternal corticosteriods use, and small for gestational age (SGA). Clinical site will be used as a","text_display":" maternal corticosteriods use, and small for gestational age (SGA). Clinical site will be used as a","confidence":1,"confidence_rate":1},{"cnt":[[232,1652],[1815,1652],[1815,1699],[232,1699]],"region":{"top_left_x":232,"top_left_y":1652,"width":1584,"height":48},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3a273ba6cfaf4ac8a2287bd00ebc21a9","type":"text","conversion_output":true,"text":"stratifying factor to control for any confounding by site through residual, site-level treatment","text_display":" stratifying factor to control for any confounding by site through residual, site-level treatment","confidence":1,"confidence_rate":1},{"cnt":[[232,1710],[1936,1710],[1936,1755],[232,1755]],"region":{"top_left_x":232,"top_left_y":1710,"width":1704,"height":46},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"70ae1fb80fe341eebcc339d032a4e149","type":"text","conversion_output":true,"text":"imbalance. The logistic regression will be estimated using a generalized estimating equation (GEE) in","text_display":" imbalance. The logistic regression will be estimated using a generalized estimating equation (GEE) in","confidence":1,"confidence_rate":1},{"cnt":[[232,1770],[1940,1770],[1940,1815],[232,1815]],"region":{"top_left_x":232,"top_left_y":1770,"width":1709,"height":46},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eb4acfe1d89a449dba36892953f7ba3f","type":"text","conversion_output":true,"text":"order to adjust for the inherent correlation expected with multiples. Standard regression diagnostics","text_display":" order to adjust for the inherent correlation expected with multiples. Standard regression diagnostics","confidence":1,"confidence_rate":1},{"cnt":[[232,1826],[1854,1826],[1854,1876],[232,1876]],"region":{"top_left_x":232,"top_left_y":1826,"width":1623,"height":50},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9771fac4175a48d0b20ffa75ec082138","type":"text","conversion_output":true,"text":"will be used to assess model adequacy, and to examine for potential outlying or influential data","text_display":" will be used to assess model adequacy, and to examine for potential outlying or influential data","confidence":1,"confidence_rate":1},{"cnt":[[232,1886],[354,1886],[354,1931],[232,1931]],"region":{"top_left_x":232,"top_left_y":1886,"width":123,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"69de3fa15f3c4a39b66cbb8d322309bd","type":"text","conversion_output":true,"text":"points.","text_display":" points.","confidence":1,"confidence_rate":1},{"cnt":[[234,1979],[1768,1979],[1768,2026],[234,2026]],"region":{"top_left_x":234,"top_left_y":1978,"width":1535,"height":48},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c2506657d14344958bb476e177c21ee8","type":"text","conversion_output":true,"text":"Prior studies offer no basis for assuming a priori interactions between treatment arms and","text_display":"\n\nPrior studies offer no basis for assuming a priori interactions between treatment arms and","confidence":1,"confidence_rate":1},{"cnt":[[232,2037],[1863,2037],[1863,2086],[232,2086]],"region":{"top_left_x":232,"top_left_y":2036,"width":1631,"height":51},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b588fd2a3a844400ba9a835688749750","type":"text","conversion_output":true,"text":"subgroups defined by sex, race/ethnicity, gestational age, site or a combination of these groups,","text_display":" subgroups defined by sex, race/ethnicity, gestational age, site or a combination of these groups,","confidence":0.9882867336273193,"confidence_rate":0.9998844928761982},{"cnt":[[232,2097],[1833,2097],[1833,2142],[232,2142]],"region":{"top_left_x":232,"top_left_y":2096,"width":1601,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"70440d101e9c438abdb0373129c8934e","type":"text","conversion_output":true,"text":"beyond that already controlled for in the randomization. For that reason, preplanned tests for","text_display":" beyond that already controlled for in the randomization. For that reason, preplanned tests for","confidence":1,"confidence_rate":1},{"cnt":[[232,2155],[1837,2155],[1837,2202],[232,2202]],"region":{"top_left_x":232,"top_left_y":2154,"width":1605,"height":49},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b3058c5cc60b431da7f77de59a4a9168","type":"text","conversion_output":true,"text":"interactions with treatment assignment are not warranted, and not powered for. We propose,","text_display":" interactions with treatment assignment are not warranted, and not powered for. We propose,","confidence":1,"confidence_rate":1},{"cnt":[[232,2213],[1846,2213],[1846,2262],[232,2262]],"region":{"top_left_x":232,"top_left_y":2212,"width":1614,"height":51},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"51c001bcbfc94ad7a283c05a719a5b2a","type":"text","conversion_output":true,"text":"however, to table all results by subgroups for descriptive purposes and to explore in secondary","text_display":" however, to table all results by subgroups for descriptive purposes and to explore in secondary","confidence":1,"confidence_rate":1},{"cnt":[[232,2273],[1820,2273],[1820,2322],[232,2322]],"region":{"top_left_x":232,"top_left_y":2273,"width":1588,"height":50},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dea40fed638c4b9f8dd9c4650a53f6c5","type":"text","conversion_output":true,"text":"analyses possible subgroup differences by treatment group, solely for purposes of generating","text_display":" analyses possible subgroup differences by treatment group, solely for purposes of generating","confidence":1,"confidence_rate":1},{"cnt":[[232,2329],[1846,2329],[1846,2378],[232,2378]],"region":{"top_left_x":232,"top_left_y":2328,"width":1614,"height":51},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"61bf781a14d64472932da10ac7607e20","type":"text","conversion_output":true,"text":"hypotheses for future studies. In particular, there is interest in exploring subgroups defined by:","text_display":" hypotheses for future studies. In particular, there is interest in exploring subgroups defined by:","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[232,2426],[1940,2426],[1940,2473],[232,2473]],"region":{"top_left_x":232,"top_left_y":2425,"width":1709,"height":48},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7d8ff2f5b2ec4dc8b8e910b9951ec0f1","type":"text","conversion_output":true,"text":"- Consenting procedure which may vary by site (antenatal vs. deferred consent). While consenting","text_display":"\n- Consenting procedure which may vary by site (antenatal vs. deferred consent). While consenting","confidence":1,"confidence_rate":1},{"cnt":[[296,2484],[1901,2484],[1901,2533],[296,2533]],"region":{"top_left_x":296,"top_left_y":2483,"width":1606,"height":51},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb84ec66105e49149cbdebe7b629728c","type":"text","conversion_output":true,"text":"procedure differences may result in some selection bias, this will be implicity adjusted for with","text_display":" procedure differences may result in some selection bias, this will be implicity adjusted for with","confidence":1,"confidence_rate":1},{"cnt":[[1904,2643],[1955,2643],[1955,2686],[1904,2686]],"region":{"top_left_x":1903,"top_left_y":2642,"width":53,"height":44},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"97071723bf384c4fb3e083e0f2211034","type":"page_info","conversion_output":false,"text":"32","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-33","page":33,"lines":[{"cnt":[[168,62],[1222,62],[1222,116],[168,116]],"region":{"top_left_x":167,"top_left_y":62,"width":1056,"height":55},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61345ccc74c0446484e41e5078209541","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) Study","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1491,62],[1916,62],[1916,114],[1491,114]],"region":{"top_left_x":1491,"top_left_y":62,"width":426,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4febc7453504dcf933c955c6e595554","type":"page_info","conversion_output":false,"text":"Version 2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[292,178],[1910,178],[1910,230],[292,230]],"region":{"top_left_x":292,"top_left_y":178,"width":1618,"height":52},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"334b4e882de742d5bdd324b27db0b131","type":"text","conversion_output":true,"text":"the already planned clinical site stratification factor. Additionally, the sample size still results in","text_display":"\nthe already planned clinical site stratification factor. Additionally, the sample size still results in","confidence":1,"confidence_rate":1},{"cnt":[[292,234],[1886,234],[1886,286],[292,286]],"region":{"top_left_x":292,"top_left_y":234,"width":1595,"height":52},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ecc2e95cce8b4304b8f2978b3ace8a2b","type":"text","conversion_output":true,"text":"\\(80 \\%\\) power at \\(\\alpha=0.038\\) for the primary outcome even if the selection bias results in a reduced","text_display":" \\(80 \\%\\) power at \\(\\alpha=0.038\\) for the primary outcome even if the selection bias results in a reduced","confidence":0.9970731723589665,"confidence_rate":0.9999703931738784},{"cnt":[[292,296],[591,296],[591,342],[292,342]],"region":{"top_left_x":292,"top_left_y":296,"width":299,"height":46},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"97bce43166a747a3b198cdaef2c9626f","type":"text","conversion_output":true,"text":"control arm rate.","text_display":" control arm rate.","confidence":1,"confidence_rate":1},{"cnt":[[232,357],[1841,357],[1841,406],[232,406]],"region":{"top_left_x":232,"top_left_y":356,"width":1610,"height":51},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5508afb44ae349a29f49a0a46c8f911b","type":"text","conversion_output":true,"text":"- Route of treatment (facemask vs. nasopharyngeal tube). While not expected to modify the","text_display":"\n- Route of treatment (facemask vs. nasopharyngeal tube). While not expected to modify the","confidence":1,"confidence_rate":1},{"cnt":[[294,415],[1949,415],[1949,466],[294,466]],"region":{"top_left_x":294,"top_left_y":414,"width":1655,"height":53},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"77483a8567db41929b607ccb795ec717","type":"text","conversion_output":true,"text":"intervention effectiveness, exploring this difference will be important for future study design and","text_display":" intervention effectiveness, exploring this difference will be important for future study design and","confidence":1,"confidence_rate":1},{"cnt":[[292,473],[576,473],[576,522],[292,522]],"region":{"top_left_x":292,"top_left_y":472,"width":284,"height":51},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1329ef3526c14685a2aaf10c30f1911c","type":"text","conversion_output":true,"text":"clinical practice.","text_display":" clinical practice.","confidence":1,"confidence_rate":1},{"cnt":[[232,533],[1745,533],[1745,587],[232,587]],"region":{"top_left_x":232,"top_left_y":532,"width":1513,"height":55},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b1689e3d728c47d3a38e95465960a9e1","type":"text","conversion_output":true,"text":"- Enrollment date. Clinical practices unrelated to this intervention, as well as increased","text_display":"\n- Enrollment date. Clinical practices unrelated to this intervention, as well as increased","confidence":1,"confidence_rate":1},{"cnt":[[292,591],[1912,591],[1912,642],[292,642]],"region":{"top_left_x":292,"top_left_y":590,"width":1621,"height":53},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c22999ae72224404b6bd116a144aaff0","type":"text","conversion_output":true,"text":"intervention experience, could result in changes in the clinical effectiveness of the intervention","text_display":" intervention experience, could result in changes in the clinical effectiveness of the intervention","confidence":1,"confidence_rate":1},{"cnt":[[292,649],[1830,649],[1830,703],[292,703]],"region":{"top_left_x":292,"top_left_y":648,"width":1539,"height":55},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e3bda2abe9d44d01b7c6af7f6fa467d0","type":"text","conversion_output":true,"text":"over time (positively or negatively). We will explore graphically any temporal trends in the","text_display":" over time (positively or negatively). We will explore graphically any temporal trends in the","confidence":1,"confidence_rate":1},{"cnt":[[292,709],[1953,709],[1953,758],[292,758]],"region":{"top_left_x":292,"top_left_y":708,"width":1661,"height":51},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"787cb7f90a39463d8aad9e6fa40e7e70","type":"text","conversion_output":true,"text":"intervention effect, and will allow/test for a time-varying treatment effect via a functional logistic","text_display":" intervention effect, and will allow/test for a time-varying treatment effect via a functional logistic","confidence":1,"confidence_rate":1},{"cnt":[[292,761],[1830,761],[1830,819],[292,819]],"region":{"top_left_x":292,"top_left_y":760,"width":1539,"height":59},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"46da2c05543942888077c7f2a58a06f5","type":"text","conversion_output":true,"text":"regression model, if needed (for which the original power calculations are conservative). \\({ }^{21}\\)","text_display":" regression model, if needed (for which the original power calculations are conservative). \\({ }^{21}\\)","confidence":1,"confidence_rate":1},{"cnt":[[163,855],[874,855],[874,917],[163,917]],"region":{"top_left_x":163,"top_left_y":855,"width":712,"height":63},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"480b91bfdc10440e8cbcc2efda75d7e9","type":"section_header","conversion_output":false,"children_ids":["54dfde6451da4c6e8de1dd969e9fb42b"],"text":"","text_display":""},{"cnt":[[168,859],[868,859],[868,913],[168,913]],"region":{"top_left_x":167,"top_left_y":859,"width":701,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54dfde6451da4c6e8de1dd969e9fb42b","type":"text","conversion_output":true,"parent_id":"480b91bfdc10440e8cbcc2efda75d7e9","text":"6.1.3. Analysis of Secondary Outcomes","text_display":"\n\n\\subsection*{6.1.3. Analysis of Secondary Outcomes}","confidence":1,"confidence_rate":1},{"cnt":[[232,932],[1953,932],[1953,982],[232,982]],"region":{"top_left_x":232,"top_left_y":932,"width":1721,"height":50},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d5b5987c4b904ccab955852622db6123","type":"text","conversion_output":true,"text":"Secondary outcomes will be analyzed using similar procedures to the primary outcome. Comparisons","text_display":"\n\nSecondary outcomes will be analyzed using similar procedures to the primary outcome. Comparisons","confidence":1,"confidence_rate":1},{"cnt":[[232,990],[1854,990],[1854,1042],[232,1042]],"region":{"top_left_x":232,"top_left_y":990,"width":1623,"height":52},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d00895b77b714889acf8633524169540","type":"text","conversion_output":true,"text":"between treatment arms will use logistic regression (dichotomous outcomes), linear regression","text_display":" between treatment arms will use logistic regression (dichotomous outcomes), linear regression","confidence":1,"confidence_rate":1},{"cnt":[[232,1048],[1676,1048],[1676,1102],[232,1102]],"region":{"top_left_x":232,"top_left_y":1048,"width":1444,"height":55},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4cfa0970978d43d0ba76f42cf2d305c2","type":"text","conversion_output":true,"text":"(continuous outcomes), or survival analysis (survival time outcomes), as appropriate.","text_display":" (continuous outcomes), or survival analysis (survival time outcomes), as appropriate.","confidence":1,"confidence_rate":1},{"cnt":[[163,1134],[606,1134],[606,1201],[163,1201]],"region":{"top_left_x":163,"top_left_y":1134,"width":443,"height":67},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fbd91a7ff20147639ce0b6b52fcba4ca","type":"section_header","conversion_output":false,"children_ids":["7d141fe35f864cf68ac82c30d4b99ec0"],"text":"","text_display":""},{"cnt":[[168,1143],[599,1143],[599,1192],[168,1192]],"region":{"top_left_x":167,"top_left_y":1142,"width":433,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d141fe35f864cf68ac82c30d4b99ec0","type":"text","conversion_output":true,"parent_id":"fbd91a7ff20147639ce0b6b52fcba4ca","text":"6.2. Interim Analysis","text_display":"\n\n\\subsection*{6.2. Interim Analysis}","confidence":0.98974609375,"confidence_rate":0.9996036616509795},{"cnt":[[168,1212],[1919,1212],[1919,1263],[168,1263]],"region":{"top_left_x":167,"top_left_y":1211,"width":1752,"height":53},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8175aa49662f4bc9b9784c57c2e9db5f","type":"text","conversion_output":true,"text":"Since neonatal safety is a consideration in this study, we have chosen to use a group sequential design.","text_display":"\n\nSince neonatal safety is a consideration in this study, we have chosen to use a group sequential design.","confidence":1,"confidence_rate":1},{"cnt":[[168,1272],[1876,1272],[1876,1321],[168,1321]],"region":{"top_left_x":167,"top_left_y":1271,"width":1709,"height":51},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"174e5b4bcc4e48f6be06096ebc8d6757","type":"text","conversion_output":true,"text":"Thus, in addition to the final analysis, we are planning on performing two interim statistical analyses","text_display":" Thus, in addition to the final analysis, we are planning on performing two interim statistical analyses","confidence":1,"confidence_rate":1},{"cnt":[[168,1328],[1944,1328],[1944,1379],[168,1379]],"region":{"top_left_x":167,"top_left_y":1327,"width":1778,"height":53},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6e090f1279fd4d6ea1e01f68eb8c1b08","type":"text","conversion_output":true,"text":"during the course of this study. The purpose of the interim analyses will be to determine whether or not","text_display":" during the course of this study. The purpose of the interim analyses will be to determine whether or not","confidence":0.98974609375,"confidence_rate":0.9999054463080289},{"cnt":[[168,1388],[1893,1388],[1893,1437],[168,1437]],"region":{"top_left_x":167,"top_left_y":1387,"width":1726,"height":51},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ff5b03bacb324983987c8c252d11276a","type":"text","conversion_output":true,"text":"there is sufficient evidence of a difference between the treatment arms in the primary endpoint such","text_display":" there is sufficient evidence of a difference between the treatment arms in the primary endpoint such","confidence":0.9990234375,"confidence_rate":0.9999906949037896},{"cnt":[[168,1446],[1916,1446],[1916,1497],[168,1497]],"region":{"top_left_x":167,"top_left_y":1445,"width":1750,"height":53},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5e1142671b9e417388b5efbb928a3d5d","type":"text","conversion_output":true,"text":"that the trial should be discontinued prior to reaching the target accrual goal. The interim analyses will","text_display":" that the trial should be discontinued prior to reaching the target accrual goal. The interim analyses will","confidence":1,"confidence_rate":1},{"cnt":[[168,1504],[1815,1504],[1815,1555],[168,1555]],"region":{"top_left_x":167,"top_left_y":1503,"width":1649,"height":53},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"522fdae1ff11431980e1e80f79c7b0c6","type":"text","conversion_output":true,"text":"be performed after approximately \\(1 / 3\\) ( 200 subjects) and \\(2 / 3\\) ( 400 subjects) of the total required","text_display":" be performed after approximately \\(1 / 3\\) ( 200 subjects) and \\(2 / 3\\) ( 400 subjects) of the total required","confidence":0.8536951517935449,"confidence_rate":0.9986254576018478},{"cnt":[[168,1564],[1893,1564],[1893,1613],[168,1613]],"region":{"top_left_x":167,"top_left_y":1564,"width":1726,"height":50},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5253f716b004427a950b94ceccd2e0e2","type":"text","conversion_output":true,"text":"patients have completed their primary outcome. An additional safety review will be undertaken after","text_display":" patients have completed their primary outcome. An additional safety review will be undertaken after","confidence":1,"confidence_rate":1},{"cnt":[[168,1620],[1171,1620],[1171,1674],[168,1674]],"region":{"top_left_x":167,"top_left_y":1619,"width":1004,"height":55},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c2c67d435394d4da76bb1b912edb6c1","type":"text","conversion_output":true,"text":"1/6 (100 subjects) have completed their primary outcome.","text_display":" 1/6 (100 subjects) have completed their primary outcome.","confidence":0.938650019466877,"confidence_rate":0.9989626272063118},{"cnt":[[168,1714],[1815,1714],[1815,1766],[168,1766]],"region":{"top_left_x":167,"top_left_y":1714,"width":1649,"height":53},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"83266e962b2743798c882caf64de5154","type":"text","conversion_output":true,"text":"The primary outcome for the interim analyses will be the comparison of death/BPD between the","text_display":"\n\nThe primary outcome for the interim analyses will be the comparison of death/BPD between the","confidence":1,"confidence_rate":1},{"cnt":[[168,1775],[1867,1775],[1867,1824],[168,1824]],"region":{"top_left_x":167,"top_left_y":1774,"width":1700,"height":51},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f63dda09a4f64775812750e3709f2bf5","type":"text","conversion_output":true,"text":"treatment arms. This comparison will be accomplished by means of a simple generalized estimating","text_display":" treatment arms. This comparison will be accomplished by means of a simple generalized estimating","confidence":0.9990234375,"confidence_rate":0.9999903263869102},{"cnt":[[168,1830],[1919,1830],[1919,1884],[168,1884]],"region":{"top_left_x":167,"top_left_y":1830,"width":1752,"height":55},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d20c6bffa1264d30b4406b492d2de356","type":"text","conversion_output":true,"text":"equation (GEE) model for death/BPD versus treatment (since adjustment for multiples will be needed).","text_display":" equation (GEE) model for death/BPD versus treatment (since adjustment for multiples will be needed).","confidence":1,"confidence_rate":1},{"cnt":[[168,1891],[1884,1891],[1884,1940],[168,1940]],"region":{"top_left_x":167,"top_left_y":1890,"width":1718,"height":51},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f3c4c043e5843e1ac5ff37819be8328","type":"text","conversion_output":true,"text":"An approximate O'Brien-Fleming boundary will be used at each interim look to calculate the nominal","text_display":" An approximate O'Brien-Fleming boundary will be used at each interim look to calculate the nominal","confidence":0.953125,"confidence_rate":0.9995339996877495},{"cnt":[[168,1942],[1807,1942],[1807,2000],[168,2000]],"region":{"top_left_x":167,"top_left_y":1942,"width":1640,"height":59},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7393d7e8c84944e89a6aa81368f76f14","type":"text","conversion_output":true,"text":"significance level to which interim p-values are compared. \\({ }^{22}\\) Using the O'Brien Fleming spending","text_display":" significance level to which interim p-values are compared. \\({ }^{22}\\) Using the O'Brien Fleming spending","confidence":0.9219503402709961,"confidence_rate":0.9992681605580622},{"cnt":[[168,2007],[1888,2007],[1888,2058],[168,2058]],"region":{"top_left_x":167,"top_left_y":2006,"width":1722,"height":53},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9b009d38d31f4568aedabe39416ceb42","type":"text","conversion_output":true,"text":"function, the three analyses ( 2 interim + final) should use the following incremental \\(\\alpha\\) values ( 0.0002 ,","text_display":" function, the three analyses ( 2 interim + final) should use the following incremental \\(\\alpha\\) values ( 0.0002 ,","confidence":0.7968150033152974,"confidence_rate":0.998155096260813},{"cnt":[[168,2067],[1119,2067],[1119,2116],[168,2116]],"region":{"top_left_x":167,"top_left_y":2066,"width":953,"height":51},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"856f9ec03bd543c3bc2e3037b71e3f1f","type":"text","conversion_output":true,"text":"0.012 , and 0.038 ) in order to achieve an overall \\(\\alpha=0.05\\).","text_display":" 0.012 , and 0.038 ) in order to achieve an overall \\(\\alpha=0.05\\).","confidence":0.9511814117431641,"confidence_rate":0.9992748938036324},{"cnt":[[163,2155],[604,2155],[604,2215],[163,2215]],"region":{"top_left_x":163,"top_left_y":2154,"width":441,"height":62},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0acef1b57cb24b3ea01bd14a19538d77","type":"section_header","conversion_output":false,"children_ids":["439bb7d459b64b77b814d814e19f7bd3"],"text":"","text_display":""},{"cnt":[[168,2161],[599,2161],[599,2211],[168,2211]],"region":{"top_left_x":167,"top_left_y":2161,"width":433,"height":50},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"439bb7d459b64b77b814d814e19f7bd3","type":"text","conversion_output":true,"parent_id":"0acef1b57cb24b3ea01bd14a19538d77","text":"Stopping criteria are for:","text_display":"\n\n\\section*{Stopping criteria are for:}","confidence":1,"confidence_rate":1},{"cnt":[[168,2252],[1893,2252],[1893,2305],[168,2305]],"region":{"top_left_x":167,"top_left_y":2251,"width":1726,"height":55},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2df2faf5cf29431a86664e36e3b07ee5","type":"text","conversion_output":true,"text":"(1) Clear superiority. Whether the experimental treatment is clearly inferior to standard therapy. For","text_display":"\n(1) Clear superiority. Whether the experimental treatment is clearly inferior to standard therapy. For","confidence":1,"confidence_rate":1},{"cnt":[[168,2312],[1798,2312],[1798,2361],[168,2361]],"region":{"top_left_x":167,"top_left_y":2311,"width":1632,"height":51},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a42d638f6a17414597c8a2f15a30c77f","type":"text","conversion_output":true,"text":"these calculations, we trade off the power to detect a difference and the size of that difference.","text_display":" these calculations, we trade off the power to detect a difference and the size of that difference.","confidence":1,"confidence_rate":1},{"cnt":[[168,2368],[1944,2368],[1944,2419],[168,2419]],"region":{"top_left_x":167,"top_left_y":2367,"width":1778,"height":53},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"61a15e4d11914f498b4ef5bc16c4a42f","type":"text","conversion_output":true,"text":"Assuming \\(\\alpha=0.0002\\) for boundaries for the initial interim analysis when 200 children have been followed","text_display":" Assuming \\(\\alpha=0.0002\\) for boundaries for the initial interim analysis when 200 children have been followed","confidence":0.99853515625,"confidence_rate":0.9999870273612914},{"cnt":[[168,2428],[1880,2428],[1880,2477],[168,2477]],"region":{"top_left_x":167,"top_left_y":2427,"width":1713,"height":51},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cf85e42ac217413891c1d03b4a363294","type":"text","conversion_output":true,"text":"to completion, power is limited except to detect large reductions in outcomes of death and BPD. For","text_display":" to completion, power is limited except to detect large reductions in outcomes of death and BPD. For","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[168,2488],[1888,2488],[1888,2537],[168,2537]],"region":{"top_left_x":167,"top_left_y":2487,"width":1722,"height":51},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a09f89feaa014301bc7526791bb4ec29","type":"text","conversion_output":true,"text":"example, power is approximately 0.81 to detect a reduction from \\(65 \\%\\) in the conventional therapy to","text_display":" example, power is approximately 0.81 to detect a reduction from \\(65 \\%\\) in the conventional therapy to","confidence":0.9990234375,"confidence_rate":0.9999910363736797},{"cnt":[[1904,2643],[1957,2643],[1957,2686],[1904,2686]],"region":{"top_left_x":1903,"top_left_y":2642,"width":55,"height":44},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e0e7aef027514f65973a81eb7e8d64c3","type":"page_info","conversion_output":false,"text":"33","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-34","page":34,"lines":[{"cnt":[[168,60],[1222,60],[1222,116],[168,116]],"region":{"top_left_x":167,"top_left_y":60,"width":1056,"height":57},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"301e329496b34fb2af854bda1758d6d7","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) Study","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1491,62],[1916,62],[1916,114],[1491,114]],"region":{"top_left_x":1491,"top_left_y":62,"width":426,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b1c3710ca2314ba98436b0122b0f9727","type":"page_info","conversion_output":false,"text":"Version 2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[168,176],[1858,176],[1858,230],[168,230]],"region":{"top_left_x":167,"top_left_y":176,"width":1692,"height":54},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"66ad24bc7a9645ffb9dd18af113441c7","type":"text","conversion_output":true,"text":"\\(32.5 \\%\\) in the experimental therapy, a 50\\% relative reduction. For the second interim analysis, using","text_display":"\n\\(32.5 \\%\\) in the experimental therapy, a 50\\% relative reduction. For the second interim analysis, using","confidence":0.9265382289886475,"confidence_rate":0.9992594978762247},{"cnt":[[168,232],[1904,232],[1904,288],[168,288]],"region":{"top_left_x":167,"top_left_y":232,"width":1737,"height":56},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"70dd4b562619448a868385b049a42822","type":"text","conversion_output":true,"text":"\\(\\alpha=0.012\\), power with 400 children followed is about 0.85 to detect an absolute reduction from \\(65 \\%\\) to","text_display":" \\(\\alpha=0.012\\), power with 400 children followed is about 0.85 to detect an absolute reduction from \\(65 \\%\\) to","confidence":0.9990236759185791,"confidence_rate":0.9999913557807578},{"cnt":[[168,294],[1919,294],[1919,346],[168,346]],"region":{"top_left_x":167,"top_left_y":294,"width":1752,"height":52},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c0df0b17e11c4c42bfe80c4cfcc5ee05","type":"text","conversion_output":true,"text":"\\(40 \\%\\) in the risk of death plus BPD. Thus, early or premature stopping for superiority is unlikely, without","text_display":" \\(40 \\%\\) in the risk of death plus BPD. Thus, early or premature stopping for superiority is unlikely, without","confidence":0.99755859375,"confidence_rate":0.9999775746428119},{"cnt":[[168,352],[1091,352],[1091,404],[168,404]],"region":{"top_left_x":167,"top_left_y":352,"width":925,"height":52},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"769ed27e9a634d7b9b31abfe8b353d03","type":"text","conversion_output":true,"text":"dramatic improvement from experimental treatment.","text_display":" dramatic improvement from experimental treatment.","confidence":1,"confidence_rate":1},{"cnt":[[168,443],[1916,443],[1916,501],[168,501]],"region":{"top_left_x":167,"top_left_y":442,"width":1750,"height":59},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1fcd3eb013694d9491535685243cbda8","type":"text","conversion_output":true,"text":"(2) Inferiority. Power is limited to identify inferiority of the experimental treatment, with 0.8 power to","text_display":"\n(2) Inferiority. Power is limited to identify inferiority of the experimental treatment, with 0.8 power to","confidence":1,"confidence_rate":1},{"cnt":[[168,503],[1957,503],[1957,556],[168,556]],"region":{"top_left_x":167,"top_left_y":502,"width":1791,"height":55},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6ea32a718af4261a78660ca0ac003ce","type":"text","conversion_output":true,"text":"demonstrate a \\(15 \\%\\) point increase in the risk of outcome from \\(65 \\%\\) in the standard therapy to \\(80 \\%\\) in the","text_display":" demonstrate a \\(15 \\%\\) point increase in the risk of outcome from \\(65 \\%\\) in the standard therapy to \\(80 \\%\\) in the","confidence":0.99951171875,"confidence_rate":0.9999957896597419},{"cnt":[[168,563],[402,563],[402,612],[168,612]],"region":{"top_left_x":167,"top_left_y":562,"width":235,"height":51},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9fe21a010a004bdcb7612f5fc8338ac1","type":"text","conversion_output":true,"text":"intervention.","text_display":" intervention.","confidence":1,"confidence_rate":1},{"cnt":[[168,653],[1955,653],[1955,711],[168,711]],"region":{"top_left_x":167,"top_left_y":653,"width":1789,"height":59},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b3e2ed7eed0f4f81acec3312d142aba7","type":"text","conversion_output":true,"text":"(3) Futility. Early stopping based on futility of the primary outcome will not be considered independently","text_display":"\n(3) Futility. Early stopping based on futility of the primary outcome will not be considered independently","confidence":1,"confidence_rate":1},{"cnt":[[168,713],[1876,713],[1876,769],[168,769]],"region":{"top_left_x":167,"top_left_y":713,"width":1709,"height":57},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c1d15fd7790d4aa2b2a37968ac036a50","type":"text","conversion_output":true,"text":"of the secondary clinical and safety outcomes. In the event that the intervention arm has equivalent","text_display":" of the secondary clinical and safety outcomes. In the event that the intervention arm has equivalent","confidence":1,"confidence_rate":1},{"cnt":[[168,769],[1899,769],[1899,827],[168,827]],"region":{"top_left_x":167,"top_left_y":769,"width":1733,"height":59},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ae61fbe0df0b4175968280b668d40099","type":"text","conversion_output":true,"text":"BPD/death rates to the standard care arm, it would still be clinically useful to know if the intervention","text_display":" BPD/death rates to the standard care arm, it would still be clinically useful to know if the intervention","confidence":1,"confidence_rate":1},{"cnt":[[168,829],[1910,829],[1910,883],[168,883]],"region":{"top_left_x":167,"top_left_y":829,"width":1743,"height":55},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7f8331260b9a41c5a5c092b57b60f009","type":"text","conversion_output":true,"text":"improves any of the secondary outcomes (that are closer to the time of the intervention) or decreases","text_display":" improves any of the secondary outcomes (that are closer to the time of the intervention) or decreases","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[168,889],[707,889],[707,939],[168,939]],"region":{"top_left_x":167,"top_left_y":889,"width":540,"height":50},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"35d8f521fb324c2e84d6ff5e573d11f8","type":"text","conversion_output":true,"text":"the serious adverse event rate.","text_display":" the serious adverse event rate.","confidence":1,"confidence_rate":1},{"cnt":[[163,975],[363,975],[363,1042],[163,1042]],"region":{"top_left_x":163,"top_left_y":975,"width":201,"height":67},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b383bd0c776b4324ba7db7f56b7e5aba","type":"section_header","conversion_output":false,"children_ids":["90e5814de55e4c258b186efa6169f71f"],"text":"","text_display":""},{"cnt":[[168,982],[357,982],[357,1036],[168,1036]],"region":{"top_left_x":167,"top_left_y":981,"width":190,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90e5814de55e4c258b186efa6169f71f","type":"text","conversion_output":true,"parent_id":"b383bd0c776b4324ba7db7f56b7e5aba","text":"(4) Safety.","text_display":"\n\n\\section*{(4) Safety.}","confidence":1,"confidence_rate":1},{"cnt":[[168,1040],[1940,1040],[1940,1096],[168,1096]],"region":{"top_left_x":167,"top_left_y":1039,"width":1774,"height":57},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"95dd546640874d57a0ac765e37b658b6","type":"text","conversion_output":true,"text":"(a) Early stopping based on inferior safety and non-inferior efficacy must be based largely on descriptive","text_display":"\n(a) Early stopping based on inferior safety and non-inferior efficacy must be based largely on descriptive","confidence":1,"confidence_rate":1},{"cnt":[[168,1100],[1910,1100],[1910,1154],[168,1154]],"region":{"top_left_x":167,"top_left_y":1100,"width":1743,"height":54},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"076b424d42b346f3873a4ec5fd3c4f97","type":"text","conversion_output":true,"text":"data and close examination of adverse events. With 200 subjects per group at a second early stopping","text_display":" data and close examination of adverse events. With 200 subjects per group at a second early stopping","confidence":1,"confidence_rate":1},{"cnt":[[168,1160],[1820,1160],[1820,1212],[168,1212]],"region":{"top_left_x":167,"top_left_y":1160,"width":1653,"height":52},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d975558a13ce41ccbc5b78fbf26cb5f6","type":"text","conversion_output":true,"text":"review, and assuming that the experimental therapy is actually no worse than conventional care,","text_display":" review, and assuming that the experimental therapy is actually no worse than conventional care,","confidence":1,"confidence_rate":1},{"cnt":[[168,1216],[1897,1216],[1897,1270],[168,1270]],"region":{"top_left_x":167,"top_left_y":1216,"width":1731,"height":54},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c72bcbaed61148679097d0f74021e325","type":"text","conversion_output":true,"text":"observed risk in the experimental group would have to be at most 0.5 (risk of death and BPD) to have","text_display":" observed risk in the experimental group would have to be at most 0.5 (risk of death and BPD) to have","confidence":1,"confidence_rate":1},{"cnt":[[168,1274],[1227,1274],[1227,1330],[168,1330]],"region":{"top_left_x":167,"top_left_y":1274,"width":1060,"height":56},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f58f6556d1b4fe79a6ef7cc87bd1a53","type":"text","conversion_output":true,"text":"\\(80 \\%\\) power to show non-inferior efficacy (with alpha \\(=0.012\\) ).","text_display":" \\(80 \\%\\) power to show non-inferior efficacy (with alpha \\(=0.012\\) ).","confidence":0.984870433807373,"confidence_rate":0.9997758312215769},{"cnt":[[168,1366],[1824,1366],[1824,1422],[168,1422]],"region":{"top_left_x":167,"top_left_y":1366,"width":1658,"height":57},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5f1242151f9848d1a7c5313a5f892597","type":"text","conversion_output":true,"text":"(b) To justify stopping for non-inferior efficacy and superior safety again will require a substantial","text_display":"\n(b) To justify stopping for non-inferior efficacy and superior safety again will require a substantial","confidence":1,"confidence_rate":1},{"cnt":[[168,1427],[1583,1427],[1583,1480],[168,1480]],"region":{"top_left_x":167,"top_left_y":1426,"width":1417,"height":55},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8356ec73a50f4d838ba282df86712c9a","type":"text","conversion_output":true,"text":"observed improvement in the experimental arm at the second early stopping time.","text_display":" observed improvement in the experimental arm at the second early stopping time.","confidence":0.99951171875,"confidence_rate":0.9999941857252588},{"cnt":[[168,1517],[1833,1517],[1833,1575],[168,1575]],"region":{"top_left_x":167,"top_left_y":1516,"width":1666,"height":59},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"475ee500b7d74431aaeee4be44023d36","type":"text","conversion_output":true,"text":"(c) Another safety outcome is the rate of pneumothorax, pulmonary interstitial emphysema (PIE),","text_display":"\n(c) Another safety outcome is the rate of pneumothorax, pulmonary interstitial emphysema (PIE),","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[168,1577],[1772,1577],[1772,1635],[168,1635]],"region":{"top_left_x":167,"top_left_y":1576,"width":1606,"height":59},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1d15fa0c344243c1a0931706261a8145","type":"text","conversion_output":true,"text":"and/or other serious adverse events (that have been adjudicated as potentially relating to the","text_display":" and/or other serious adverse events (that have been adjudicated as potentially relating to the","confidence":1,"confidence_rate":1},{"cnt":[[168,1637],[1863,1637],[1863,1691],[168,1691]],"region":{"top_left_x":167,"top_left_y":1637,"width":1696,"height":54},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc630df38d12448a8bef50871f50d8e3","type":"text","conversion_output":true,"text":"intervention; see section 8.2.2). In order to minimize the risk, this safety outcome will be compared","text_display":" intervention; see section 8.2.2). In order to minimize the risk, this safety outcome will be compared","confidence":1,"confidence_rate":1},{"cnt":[[168,1695],[1953,1695],[1953,1749],[168,1749]],"region":{"top_left_x":167,"top_left_y":1695,"width":1786,"height":54},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1d0f385ea2854eb28e55b3f5d8ac0ea1","type":"text","conversion_output":true,"text":"between treatment arms after \\(1 / 6\\) ( 100 subjects) have completed the primary outcome, as well as at the","text_display":" between treatment arms after \\(1 / 6\\) ( 100 subjects) have completed the primary outcome, as well as at the","confidence":0.6839031987776707,"confidence_rate":0.9966433550768367},{"cnt":[[165,1753],[1884,1753],[1884,1811],[165,1811]],"region":{"top_left_x":165,"top_left_y":1753,"width":1720,"height":59},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f35969c51fd44684bc6d6b836de2c832","type":"text","conversion_output":true,"text":"two planned interim analyses for the primary outcome ( \\(1 / 3\\) and \\(2 / 3\\) ), since we would not expect any","text_display":" two planned interim analyses for the primary outcome ( \\(1 / 3\\) and \\(2 / 3\\) ), since we would not expect any","confidence":0.9800873349387302,"confidence_rate":0.9998171658616185},{"cnt":[[168,1813],[1927,1813],[1927,1867],[168,1867]],"region":{"top_left_x":167,"top_left_y":1813,"width":1761,"height":54},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e61a1ebd1b574119ad79dde8e35e2d35","type":"text","conversion_output":true,"text":"statistically significant differences in the rate after 100 subjects (with O'Brien-Fleming alpha 0.000002).","text_display":" statistically significant differences in the rate after 100 subjects (with O'Brien-Fleming alpha 0.000002).","confidence":0.856837353669107,"confidence_rate":0.9986573615893318},{"cnt":[[168,1869],[1919,1869],[1919,1927],[168,1927]],"region":{"top_left_x":167,"top_left_y":1869,"width":1752,"height":59},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9f7716a64d5b4f0c857dd284eb8bee22","type":"text","conversion_output":true,"text":"Instead, we will look for a clinically meaningful double the risk in the intervention versus standard care","text_display":" Instead, we will look for a clinically meaningful double the risk in the intervention versus standard care","confidence":1,"confidence_rate":1},{"cnt":[[168,1934],[277,1934],[277,1979],[168,1979]],"region":{"top_left_x":167,"top_left_y":1933,"width":111,"height":46},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d71796daed8a4f818e2d181d8ce37a87","type":"text","conversion_output":true,"text":"arms.","text_display":" arms.","confidence":1,"confidence_rate":1},{"cnt":[[168,2024],[1953,2024],[1953,2078],[168,2078]],"region":{"top_left_x":167,"top_left_y":2023,"width":1786,"height":55},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f25a1d3b0b54951b12a006c7cdda8e0","type":"text","conversion_output":true,"text":"In summary, given the projected number of patients to be enrolled, early stopping will be unlikely unless","text_display":"\n\nIn summary, given the projected number of patients to be enrolled, early stopping will be unlikely unless","confidence":1,"confidence_rate":1},{"cnt":[[168,2082],[1893,2082],[1893,2138],[168,2138]],"region":{"top_left_x":167,"top_left_y":2081,"width":1726,"height":57},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e95bcb0c05f44cbe8cac9e0c79411b5c","type":"text","conversion_output":true,"text":"the observed effect of experimental care is clearly better or worse than standard care at the planned","text_display":" the observed effect of experimental care is clearly better or worse than standard care at the planned","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[168,2140],[741,2140],[741,2194],[168,2194]],"region":{"top_left_x":167,"top_left_y":2139,"width":575,"height":55},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"db2af0e95a7746a9b0f323c6146fe5c7","type":"text","conversion_output":true,"text":"early stopping assessment times.","text_display":" early stopping assessment times.","confidence":1,"confidence_rate":1},{"cnt":[[165,2230],[1850,2230],[1850,2288],[165,2288]],"region":{"top_left_x":165,"top_left_y":2230,"width":1685,"height":59},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"058779430cda43db9e51b28136ea4e95","type":"text","conversion_output":true,"text":"The results of the interim analyses will be judged by the DSMC. This committee will act completely","text_display":"\n\nThe results of the interim analyses will be judged by the DSMC. This committee will act completely","confidence":0.98876953125,"confidence_rate":0.9998903554617051},{"cnt":[[168,2290],[1914,2290],[1914,2346],[168,2346]],"region":{"top_left_x":167,"top_left_y":2290,"width":1748,"height":57},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0286c573ee784a8eb0adb83e3583c11c","type":"text","conversion_output":true,"text":"independently of the clinical investigators, including the Principal Investigators. However, the ultimate","text_display":" independently of the clinical investigators, including the Principal Investigators. However, the ultimate","confidence":1,"confidence_rate":1},{"cnt":[[168,2350],[1265,2350],[1265,2404],[168,2404]],"region":{"top_left_x":167,"top_left_y":2350,"width":1099,"height":55},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e886995283f045308b945f451f67ae75","type":"text","conversion_output":true,"text":"decision to stop the study will rest with the steering committee.","text_display":" decision to stop the study will rest with the steering committee.","confidence":1,"confidence_rate":1},{"cnt":[[168,2445],[1876,2445],[1876,2499],[168,2499]],"region":{"top_left_x":167,"top_left_y":2444,"width":1709,"height":55},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c4ca2a83bf0348f198c589a032b79f2f","type":"text","conversion_output":true,"text":"Note: An adaptive design was not used for this study. The efficacy improvement was minor over the","text_display":"\n\nNote: An adaptive design was not used for this study. The efficacy improvement was minor over the","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[168,2501],[535,2501],[535,2554],[168,2554]],"region":{"top_left_x":167,"top_left_y":2500,"width":368,"height":55},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"99819b6b04d6442696aa02536a78d7b5","type":"text","conversion_output":true,"text":"conventional design.","text_display":" conventional design.","confidence":0.99951171875,"confidence_rate":0.9999804641709025},{"cnt":[[1904,2643],[1959,2643],[1959,2686],[1904,2686]],"region":{"top_left_x":1903,"top_left_y":2642,"width":57,"height":44},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"22a0bb5064db4736974ecaecb6bd9410","type":"page_info","conversion_output":false,"text":"34","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-35","page":35,"lines":[{"cnt":[[167,116],[168,62],[1223,64],[1222,118]],"region":{"top_left_x":167,"top_left_y":62,"width":1056,"height":57},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2ee9c4d1ec34746bf9fa7dd81c7a11c","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) Study","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1495,64],[1914,64],[1914,114],[1495,114]],"region":{"top_left_x":1495,"top_left_y":64,"width":420,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae7ef655def14b2a8efa3c856f692a3a","type":"page_info","conversion_output":false,"text":"Version 2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[168,176],[720,176],[720,243],[168,243]],"region":{"top_left_x":167,"top_left_y":176,"width":553,"height":67},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53e840d8d64a489b8828892267ecd3b0","type":"section_header","conversion_output":false,"children_ids":["c4024bb6193d4417b36e8a3ad726b0f1"],"text":"","text_display":""},{"cnt":[[172,180],[715,180],[715,238],[172,238]],"region":{"top_left_x":171,"top_left_y":180,"width":545,"height":59},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c4024bb6193d4417b36e8a3ad726b0f1","type":"text","conversion_output":true,"parent_id":"53e840d8d64a489b8828892267ecd3b0","text":"7. 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studies;","confidence":1,"confidence_rate":1},{"cnt":[[296,395],[1949,395],[1949,440],[296,440]],"region":{"top_left_x":296,"top_left_y":395,"width":1653,"height":46},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac2dc03e2f164f0cbed1aa204c83f6b3","type":"text","conversion_output":true,"text":"- Review serious adverse event documentation and safety reports and make recommendations","text_display":"\n- Review serious adverse event documentation and safety reports and make recommendations","confidence":1,"confidence_rate":1},{"cnt":[[357,453],[1369,453],[1369,501],[357,501]],"region":{"top_left_x":356,"top_left_y":453,"width":1013,"height":48},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88a82d4cacce4551b719819a5adc62f7","type":"text","conversion_output":true,"text":"regarding protection of the safety of the study participants.","text_display":" regarding protection of the safety of the study participants.","confidence":1,"confidence_rate":1},{"cnt":[[232,546],[1944,546],[1944,593],[232,593]],"region":{"top_left_x":232,"top_left_y":545,"width":1713,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f11efc4e5d24785b42a929eaa12999c","type":"text","conversion_output":true,"text":"The DSMC is fully empowered to require any other specific changes to the trial (pertaining to patient","text_display":"\n\nThe DSMC is fully empowered to require any other specific changes to the trial (pertaining to patient","confidence":1,"confidence_rate":1},{"cnt":[[232,606],[1777,606],[1777,651],[232,651]],"region":{"top_left_x":232,"top_left_y":605,"width":1545,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40e73089eacc4b4ea20bd664f8e8ee48","type":"text","conversion_output":true,"text":"safety and trial feasibility issues) prior to any local IRB submissions and prior to any start to","text_display":" safety and trial feasibility issues) prior to any local IRB submissions and prior to any start to","confidence":1,"confidence_rate":1},{"cnt":[[232,662],[1884,662],[1884,711],[232,711]],"region":{"top_left_x":232,"top_left_y":661,"width":1653,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11a6c27d11b84db3a2b2770259b8e513","type":"text","conversion_output":true,"text":"enrollment. As is usual in such studies, the Steering Committee has the final responsibility for the","text_display":" enrollment. As is usual in such studies, the Steering Committee has the final responsibility for the","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[232,722],[866,722],[866,763],[232,763]],"region":{"top_left_x":232,"top_left_y":721,"width":634,"height":42},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c71c13fea5fa40dd94717c05404f3c3e","type":"text","conversion_output":true,"text":"trial and is the final seat of decisions.","text_display":" trial and is the final seat of decisions.","confidence":0.99951171875,"confidence_rate":0.9999893826542317},{"cnt":[[232,814],[1940,814],[1940,862],[232,862]],"region":{"top_left_x":232,"top_left_y":814,"width":1709,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"467cde9df8254531adb0e810890d485e","type":"text","conversion_output":true,"text":"The DSMC deliberations will summarize topics discussed, recommendations made and will be signed","text_display":"\n\nThe DSMC deliberations will summarize topics discussed, recommendations made and will be signed","confidence":1,"confidence_rate":1},{"cnt":[[232,872],[1927,872],[1927,922],[232,922]],"region":{"top_left_x":232,"top_left_y":872,"width":1696,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8886cae084fe4deb911cc6f95fc1fc4f","type":"text","conversion_output":true,"text":"by the board chair. All participating sites and their site Pls will receive a sanitized summary of board","text_display":" by the board chair. All participating sites and their site Pls will receive a sanitized summary of board","confidence":0.6645524501800537,"confidence_rate":0.9962580144112917},{"cnt":[[232,932],[1235,932],[1235,978],[232,978]],"region":{"top_left_x":232,"top_left_y":932,"width":1004,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c487062a7054f6c8b5492acb1865c81","type":"text","conversion_output":true,"text":"recommendations, to be forwarded to the IRB of each site.","text_display":" recommendations, to be forwarded to the IRB of each site.","confidence":1,"confidence_rate":1},{"cnt":[[232,1023],[1790,1023],[1790,1072],[232,1072]],"region":{"top_left_x":232,"top_left_y":1022,"width":1558,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"107bef6c23e24a6281b7129fbee328d8","type":"text","conversion_output":true,"text":"Any potential and actual Conflicts of Interest (COI) for board members will be reviewed and","text_display":"\n\nAny potential and actual Conflicts of Interest (COI) for board members will be reviewed and","confidence":0.9975595474243164,"confidence_rate":0.9999745478725159},{"cnt":[[232,1083],[647,1083],[647,1132],[232,1132]],"region":{"top_left_x":232,"top_left_y":1082,"width":415,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ebeece5cd264246b3a8283733bcc999","type":"text","conversion_output":true,"text":"managed appropriately.","text_display":" managed appropriately.","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[165,1199],[662,1199],[662,1257],[165,1257]],"region":{"top_left_x":165,"top_left_y":1198,"width":497,"height":59},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bf924769f474b899840052866f4b531","type":"section_header","conversion_output":false,"children_ids":["e6690a5a300f44abac1b2648a1bde939"],"text":"","text_display":""},{"cnt":[[172,1203],[655,1203],[655,1253],[172,1253]],"region":{"top_left_x":171,"top_left_y":1203,"width":485,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6690a5a300f44abac1b2648a1bde939","type":"text","conversion_output":true,"parent_id":"6bf924769f474b899840052866f4b531","text":"8. Research Ethics","text_display":"\n\n\\section*{8. Research Ethics}","confidence":1,"confidence_rate":1},{"cnt":[[165,1298],[599,1298],[599,1360],[165,1360]],"region":{"top_left_x":165,"top_left_y":1297,"width":435,"height":63},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7db2666beed04501878c079534d19ff0","type":"section_header","conversion_output":false,"children_ids":["a70178e1ab504efc992ad2cf2ff97c5f"],"text":"","text_display":""},{"cnt":[[172,1302],[593,1302],[593,1354],[172,1354]],"region":{"top_left_x":171,"top_left_y":1301,"width":422,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a70178e1ab504efc992ad2cf2ff97c5f","type":"text","conversion_output":true,"parent_id":"7db2666beed04501878c079534d19ff0","text":"8.1. Consent Options","text_display":"\n\n\\subsection*{8.1. Consent Options}","confidence":0.9990234375,"confidence_rate":0.9999609191777622},{"cnt":[[168,1375],[1946,1375],[1946,1422],[168,1422]],"region":{"top_left_x":167,"top_left_y":1375,"width":1780,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8fba541afb84ce1956457ec3f746f87","type":"text","conversion_output":true,"text":"We will obtain an antenatal consent of parents of likely eligible infants \\(230-266 GA\\), who may be likely to","text_display":"\n\nWe will obtain an antenatal consent of parents of likely eligible infants \\(230-266 GA\\), who may be likely to","confidence":0.9941432476043701,"confidence_rate":0.9999497963847676},{"cnt":[[168,1431],[1841,1431],[1841,1480],[168,1480]],"region":{"top_left_x":167,"top_left_y":1430,"width":1675,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d686d626b9e14ed98422bc2bca196ade","type":"text","conversion_output":true,"text":"conform to the inclusion and exclusion criteria. In this case a log will be maintained of all screened","text_display":" conform to the inclusion and exclusion criteria. In this case a log will be maintained of all screened","confidence":1,"confidence_rate":1},{"cnt":[[168,1491],[1248,1491],[1248,1540],[168,1540]],"region":{"top_left_x":167,"top_left_y":1491,"width":1082,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f2ff67b10fe4cf4978c6d0f1cb765d7","type":"text","conversion_output":true,"text":"mothers-infants indicating who are eligible and which enrolled.","text_display":" mothers-infants indicating who are eligible and which enrolled.","confidence":1,"confidence_rate":1},{"cnt":[[168,1583],[1910,1583],[1910,1635],[168,1635]],"region":{"top_left_x":167,"top_left_y":1583,"width":1743,"height":52},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f9df81a428314da1a59743bd219f5543","type":"text","conversion_output":true,"text":"We recognize that there are are serious personal burdens to mothers, practical difficulites, and finally,","text_display":"\n\nWe recognize that there are are serious personal burdens to mothers, practical difficulites, and finally,","confidence":1,"confidence_rate":1},{"cnt":[[168,1641],[1944,1641],[1944,1691],[168,1691]],"region":{"top_left_x":167,"top_left_y":1641,"width":1778,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e419b2f136b424585d6d8b39d8c2995","type":"text","conversion_output":true,"text":"serious scientific concerns arising from the antenatal consent process. These are summarized as follows:","text_display":" serious scientific concerns arising from the antenatal consent process. These are summarized as follows:","confidence":1,"confidence_rate":1},{"cnt":[[168,1736],[1910,1736],[1910,1785],[168,1785]],"region":{"top_left_x":167,"top_left_y":1735,"width":1743,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9874ef21615943f1b0ea091e76213429","type":"text","conversion_output":true,"text":"Firstly; there is already an additional burden to distraught mothers who have been informed that they","text_display":"\n\nFirstly; there is already an additional burden to distraught mothers who have been informed that they","confidence":1,"confidence_rate":1},{"cnt":[[168,1794],[1712,1794],[1712,1843],[168,1843]],"region":{"top_left_x":167,"top_left_y":1793,"width":1546,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ea7cf86fdc24e97a474854003a2f178","type":"text","conversion_output":true,"text":"are at risk of preterm delivery. This is a difficult time to absorb the message that a possible","text_display":" are at risk of preterm delivery. This is a difficult time to absorb the message that a possible","confidence":0.9951171875,"confidence_rate":0.999951053474153},{"cnt":[[168,1852],[1931,1852],[1931,1901],[168,1901]],"region":{"top_left_x":167,"top_left_y":1851,"width":1765,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a2d9da079a6b47a2b450dcfc951ae386","type":"text","conversion_output":true,"text":"randomization will be performed on their high-risk infant. Moreover, some of these these mothers may","text_display":" randomization will be performed on their high-risk infant. Moreover, some of these these mothers may","confidence":1,"confidence_rate":1},{"cnt":[[168,1912],[1884,1912],[1884,1962],[168,1962]],"region":{"top_left_x":167,"top_left_y":1912,"width":1718,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81c4ef926d354184b37cb43ad63efc2b","type":"text","conversion_output":true,"text":"not even, in fact end up delivering an eligible baby. This is because threatened preterm delivery is an","text_display":" not even, in fact end up delivering an eligible baby. This is because threatened preterm delivery is an","confidence":1,"confidence_rate":1},{"cnt":[[168,1968],[1901,1968],[1901,2017],[168,2017]],"region":{"top_left_x":167,"top_left_y":1967,"width":1735,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c220cec5c25d484495152f111e41e759","type":"text","conversion_output":true,"text":"imprecise diagnose whereby approximately \\(50 \\%\\) of mothers may not in fact deliver until after \\(26+6 / 7\\)","text_display":" imprecise diagnose whereby approximately \\(50 \\%\\) of mothers may not in fact deliver until after \\(26+6 / 7\\)","confidence":0.8948855821080228,"confidence_rate":0.9989428505090301},{"cnt":[[168,2020],[1919,2020],[1919,2078],[168,2078]],"region":{"top_left_x":167,"top_left_y":2019,"width":1752,"height":59},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e42051f982e84f3c94e3d607605d3b6e","type":"text","conversion_output":true,"text":"weeks. Data for this is shown in Rich W et al \\({ }^{17,18}\\), and we discuss its implication for selection bias in the","text_display":" weeks. Data for this is shown in Rich W et al \\({ }^{17,18}\\), and we discuss its implication for selection bias in the","confidence":0.8561127880314778,"confidence_rate":0.9987579467889791},{"cnt":[[168,2088],[370,2088],[370,2133],[168,2133]],"region":{"top_left_x":167,"top_left_y":2088,"width":203,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bdd9a6593864e8dadb43ead8483b258","type":"text","conversion_output":true,"text":"text below.","text_display":" text below.","confidence":1,"confidence_rate":1},{"cnt":[[168,2179],[1953,2179],[1953,2228],[168,2228]],"region":{"top_left_x":167,"top_left_y":2178,"width":1786,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"084fc8e6c3724a7c8f8be871e169a9ce","type":"text","conversion_output":true,"text":"Secondly, there is a limited time whereby parents can process and consider an informed consent process","text_display":"\n\nSecondly, there is a limited time whereby parents can process and consider an informed consent process","confidence":1,"confidence_rate":1},{"cnt":[[168,2239],[1919,2239],[1919,2288],[168,2288]],"region":{"top_left_x":167,"top_left_y":2238,"width":1752,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6220c66264a42cd8c8be9ad9e17f8a9","type":"text","conversion_output":true,"text":"as can be seen from a detailed analysis of administration of antenatal corticosteroids in the Hospital of","text_display":" as can be seen from a detailed analysis of administration of antenatal corticosteroids in the Hospital of","confidence":0.9892628192901611,"confidence_rate":0.9999018662681068},{"cnt":[[168,2295],[1201,2295],[1201,2348],[168,2348]],"region":{"top_left_x":167,"top_left_y":2294,"width":1034,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2206c534a8134cc4a8fdccd950fc4357","type":"text","conversion_output":true,"text":"University of Pennsylvania study, which found the following:","text_display":" University of Pennsylvania study, which found the following:","confidence":1,"confidence_rate":1},{"cnt":[[292,2385],[1665,2385],[1665,2563],[292,2563]],"region":{"top_left_x":292,"top_left_y":2384,"width":1374,"height":180},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6bd70b6a552645579c3ef86a6cb08b0b","type":"quote","conversion_output":false,"children_ids":["d950158d41e84b95ad58495f17fa2b7d","25d1a25ad56c4af79f9a125c16a64818","19a5e193f86f48a49016aa5a19601bc1"],"text":"","text_display":""},{"cnt":[[296,2389],[1661,2389],[1661,2438],[296,2438]],"region":{"top_left_x":296,"top_left_y":2389,"width":1365,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d950158d41e84b95ad58495f17fa2b7d","type":"text","conversion_output":true,"parent_id":"6bd70b6a552645579c3ef86a6cb08b0b","text":"\"Median time from presentation to delivery in those who received 1 dose ( \\(n=85\\) )","text_display":"\n> \"Median time from presentation to delivery in those who received 1 dose ( \\(n=85\\) )","confidence":0.953125,"confidence_rate":0.9994725653053936},{"cnt":[[309,2449],[1618,2449],[1618,2499],[309,2499]],"region":{"top_left_x":309,"top_left_y":2449,"width":1309,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25d1a25ad56c4af79f9a125c16a64818","type":"text","conversion_output":true,"parent_id":"6bd70b6a552645579c3ef86a6cb08b0b","text":"was 7.96 hours (IQR, 4.1-17.3). In those who did not receive ANCS ( \\(n=64\\) ), the","text_display":" was 7.96 hours (IQR, 4.1-17.3). In those who did not receive ANCS ( \\(n=64\\) ), the","confidence":0.6560969352722168,"confidence_rate":0.9953282054536705},{"cnt":[[309,2505],[1609,2505],[1609,2554],[309,2554]],"region":{"top_left_x":309,"top_left_y":2505,"width":1301,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19a5e193f86f48a49016aa5a19601bc1","type":"text","conversion_output":true,"parent_id":"6bd70b6a552645579c3ef86a6cb08b0b","text":"median time from presentation to delivery was 1.27 hours (IQR, 0.53-2.42; \\(P\\)","text_display":" median time from presentation to delivery was 1.27 hours (IQR, 0.53-2.42; \\(P\\)","confidence":0.9970722198486328,"confidence_rate":0.9999642436333762},{"cnt":[[1904,2643],[1955,2643],[1955,2696],[1904,2696]],"region":{"top_left_x":1903,"top_left_y":2642,"width":53,"height":55},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1102d1902bc844bc8216d6cea2d67051","type":"page_info","conversion_output":false,"text":"38","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-39","page":39,"lines":[{"cnt":[[168,60],[1222,60],[1222,118],[168,118]],"region":{"top_left_x":167,"top_left_y":60,"width":1056,"height":59},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2dc1022042584b309e9f0f1f2418082b","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) Study","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1491,64],[1916,64],[1916,114],[1491,114]],"region":{"top_left_x":1491,"top_left_y":64,"width":426,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1fc267f271f49158a902a0c8da0b5c1","type":"page_info","conversion_output":false,"text":"Version 2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[301,172],[1678,172],[1678,645],[301,645]],"region":{"top_left_x":300,"top_left_y":171,"width":1378,"height":474},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aade0d6f6eff48d5aca3b0a5d6b4ef19","type":"quote","conversion_output":false,"children_ids":["1bf5485ff04544ebaefdb9014309d7cf","1774881339a64713bf26b5480bd99d0c","525d84ab171f4d01a75447ca31fcbfcc","668e73a97cb5485299be7060559a7382","e3bf18a8ba7d4a8f9779d71c4436bef7","4192d0dad9cd48dd9ba918c2de662a72","0ffee10ccb204e2bba437f5ad4f4f994","bd8f21856164450b8843f3ca91fa6ddd"],"text":"","text_display":""},{"cnt":[[309,178],[1671,178],[1671,228],[309,228]],"region":{"top_left_x":309,"top_left_y":178,"width":1363,"height":50},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1bf5485ff04544ebaefdb9014309d7cf","type":"text","conversion_output":true,"parent_id":"aade0d6f6eff48d5aca3b0a5d6b4ef19","text":"<.0001). Sixty-two percent of those who received only 1 dosILCS delivered in <12","text_display":"\n> <.0001). Sixty-two percent of those who received only 1 dosILCS delivered in <12","confidence":0.9907476719275792,"confidence_rate":0.9998943760703899},{"cnt":[[309,236],[1674,236],[1674,286],[309,286]],"region":{"top_left_x":309,"top_left_y":236,"width":1365,"height":50},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1774881339a64713bf26b5480bd99d0c","type":"text","conversion_output":true,"parent_id":"aade0d6f6eff48d5aca3b0a5d6b4ef19","text":"hours after the initial presentation. Of the 64 patients who did not receive ANCS,","text_display":" hours after the initial presentation. Of the 64 patients who did not receive ANCS,","confidence":1,"confidence_rate":1},{"cnt":[[309,296],[1665,296],[1665,346],[309,346]],"region":{"top_left_x":309,"top_left_y":296,"width":1357,"height":50},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"525d84ab171f4d01a75447ca31fcbfcc","type":"text","conversion_output":true,"parent_id":"aade0d6f6eff48d5aca3b0a5d6b4ef19","text":"\\(18.7 \\%\\) ( \\(n=12\\) women), \\(21.8 \\%\\) ( \\(n=14\\) women), \\(21.8 \\%\\) ( \\(n=14\\) women), and \\(37.5 \\%\\)","text_display":" \\(18.7 \\%\\) ( \\(n=12\\) women), \\(21.8 \\%\\) ( \\(n=14\\) women), \\(21.8 \\%\\) ( \\(n=14\\) women), and \\(37.5 \\%\\)","confidence":0.9483375675671948,"confidence_rate":0.9994107874741573},{"cnt":[[309,352],[1613,352],[1613,402],[309,402]],"region":{"top_left_x":309,"top_left_y":352,"width":1305,"height":50},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"668e73a97cb5485299be7060559a7382","type":"text","conversion_output":true,"parent_id":"aade0d6f6eff48d5aca3b0a5d6b4ef19","text":"( \\(n=24\\) women) delivered at<30 minutes, \\(30-59\\) minutes, \\(60-120\\) minutes, and","text_display":" ( \\(n=24\\) women) delivered at<30 minutes, \\(30-59\\) minutes, \\(60-120\\) minutes, and","confidence":0.5232348023289676,"confidence_rate":0.9925825316974021},{"cnt":[[309,412],[1607,412],[1607,462],[309,462]],"region":{"top_left_x":309,"top_left_y":412,"width":1299,"height":50},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e3bf18a8ba7d4a8f9779d71c4436bef7","type":"text","conversion_output":true,"parent_id":"aade0d6f6eff48d5aca3b0a5d6b4ef19","text":">120 minutes after presentation, respectively.\" In addition when comparing","text_display":" >120 minutes after presentation, respectively.\" In addition when comparing","confidence":0.99853515625,"confidence_rate":0.9999814442521284},{"cnt":[[309,473],[1665,473],[1665,522],[309,522]],"region":{"top_left_x":309,"top_left_y":472,"width":1357,"height":51},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4192d0dad9cd48dd9ba918c2de662a72","type":"text","conversion_output":true,"parent_id":"aade0d6f6eff48d5aca3b0a5d6b4ef19","text":"mothers who had two doses of ANCS to those who had none or only one dose, a","text_display":" mothers who had two doses of ANCS to those who had none or only one dose, a","confidence":0.9507074356079102,"confidence_rate":0.9993683383016129},{"cnt":[[309,529],[1577,529],[1577,578],[309,578]],"region":{"top_left_x":309,"top_left_y":528,"width":1268,"height":50},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0ffee10ccb204e2bba437f5ad4f4f994","type":"text","conversion_output":true,"parent_id":"aade0d6f6eff48d5aca3b0a5d6b4ef19","text":"dose response relationship is seen such that the latter have a much higher","text_display":" dose response relationship is seen such that the latter have a much higher","confidence":1,"confidence_rate":1},{"cnt":[[309,580],[967,580],[967,638],[309,638]],"region":{"top_left_x":309,"top_left_y":580,"width":658,"height":59},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd8f21856164450b8843f3ca91fa6ddd","type":"text","conversion_output":true,"parent_id":"aade0d6f6eff48d5aca3b0a5d6b4ef19","text":"proportion of infants < GA 30 weeks. \\({ }^{24}\\)","text_display":" proportion of infants < GA 30 weeks. \\({ }^{24}\\)","confidence":0.9647444781863896,"confidence_rate":0.9993230216655647},{"cnt":[[168,681],[1914,681],[1914,733],[168,733]],"region":{"top_left_x":167,"top_left_y":681,"width":1748,"height":52},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f61db7f626db41dfb21758b33c8ad304","type":"text","conversion_output":true,"text":"Finally, there is a serious potential for selection bias of the antenatal consent process, as noted by Rich","text_display":"\n\nFinally, there is a serious potential for selection bias of the antenatal consent process, as noted by Rich","confidence":1,"confidence_rate":1},{"cnt":[[168,730],[1901,730],[1901,788],[168,788]],"region":{"top_left_x":167,"top_left_y":730,"width":1735,"height":59},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b560df23224844a1a1bdab3f0bbe6c5b","type":"text","conversion_output":true,"text":"W, et al. \\({ }^{17,18}\\) This paper outlines the major problems of generalizabilty, and it is acknowledged by the","text_display":" W, et al. \\({ }^{17,18}\\) This paper outlines the major problems of generalizabilty, and it is acknowledged by the","confidence":0.9912109375,"confidence_rate":0.9999258185992773},{"cnt":[[168,791],[1893,791],[1893,849],[168,849]],"region":{"top_left_x":167,"top_left_y":790,"width":1726,"height":59},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26b5456bb44949fbaa85d6ab3aac70db","type":"text","conversion_output":true,"text":"authors of the SUPPORT trial that this has affected its findings. \\({ }^{2}\\) Nonetheless, after careful discussion","text_display":" authors of the SUPPORT trial that this has affected its findings. \\({ }^{2}\\) Nonetheless, after careful discussion","confidence":1,"confidence_rate":1},{"cnt":[[168,855],[1951,855],[1951,907],[168,907]],"region":{"top_left_x":167,"top_left_y":855,"width":1784,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"acc5f22c27464cebbe0cdf10d00690a7","type":"text","conversion_output":true,"text":"with the IRB, we will adopt the full informed antenatal consent procedures. This is largely because of the","text_display":" with the IRB, we will adopt the full informed antenatal consent procedures. This is largely because of the","confidence":1,"confidence_rate":1},{"cnt":[[168,915],[1919,915],[1919,965],[168,965]],"region":{"top_left_x":167,"top_left_y":915,"width":1752,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7fec059c8f4c481584e2123247f68da5","type":"text","conversion_output":true,"text":"uncertainty surrounding the currrent point estimates of potential risk. This is discussed in detail below.","text_display":" uncertainty surrounding the currrent point estimates of potential risk. This is discussed in detail below.","confidence":0.9990234375,"confidence_rate":0.9999911978797494},{"cnt":[[163,1005],[1164,1005],[1164,1063],[163,1063]],"region":{"top_left_x":163,"top_left_y":1005,"width":1002,"height":59},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b25dc6d88954711b80f6a71d4276e6b","type":"section_header","conversion_output":false,"children_ids":["3a82d171b2214df6a0fb7c187d35dbe4"],"text":"","text_display":""},{"cnt":[[168,1010],[1158,1010],[1158,1057],[168,1057]],"region":{"top_left_x":167,"top_left_y":1009,"width":992,"height":49},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a82d171b2214df6a0fb7c187d35dbe4","type":"text","conversion_output":true,"parent_id":"6b25dc6d88954711b80f6a71d4276e6b","text":"8.1.1. Consent Approach and Consent Form For Families","text_display":"\n\n\\subsection*{8.1.1. Consent Approach and Consent Form For Families}","confidence":0.6649410658297106,"confidence_rate":0.9929892277423786},{"cnt":[[232,1083],[1283,1083],[1283,1128],[232,1128]],"region":{"top_left_x":232,"top_left_y":1082,"width":1051,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"995b024243f24f769bdf34868735b248","type":"text","conversion_output":true,"text":"The diagram below explains the practical sequence of events.","text_display":"\n\nThe diagram below explains the practical sequence of events.","confidence":1,"confidence_rate":1},{"cnt":[[1904,2643],[1957,2643],[1957,2696],[1904,2696]],"region":{"top_left_x":1903,"top_left_y":2642,"width":55,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b35d4afb67d94bb3b4c071b8263c65c3","type":"page_info","conversion_output":false,"text":"39","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-40","page":40,"lines":[{"cnt":[[168,62],[1222,62],[1222,116],[168,116]],"region":{"top_left_x":167,"top_left_y":62,"width":1056,"height":55},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bcfe7d2e3f8d4ab9a55bc7c81bedc8f0","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) Study","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1491,62],[1916,62],[1916,116],[1491,116]],"region":{"top_left_x":1491,"top_left_y":62,"width":426,"height":55},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b394ad563b540dcae5b979a9bec4652","type":"page_info","conversion_output":false,"text":"Version 2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[198,196],[1167,196],[1167,251],[198,251]],"region":{"top_left_x":197,"top_left_y":195,"width":970,"height":57},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2270577d8a1d48588ec3fb47514ad698","type":"figure_label","conversion_output":false,"text":"Figure 3: Screening and Consent Process Outline","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[185,301],[1884,301],[1884,2344],[185,2344]],"region":{"top_left_x":184,"top_left_y":300,"width":1701,"height":2044},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"03cc32e9cfbc4ec39453bdebc216ed01","type":"table","conversion_output":true,"children_ids":["b897dd15f88c4f0a9a1e03d2bb6ccb33","aa087e7e9b9b420e90743f0d7880d948","48efdc216c0441d592e75fd099de2361","88eb9c15905942688e87616adb7e0200","d5bc1f7666a94a9e88505961864e90b2","e296cf767b3e49d197048fa1bcf4b896","1f21aad68888409b8e67eafdd07b29ec","729a1650b6f14ce6861042fa8f013c9a","9562c681c9e54bdebabca3c255bd1325","ba0fc3ed68be410d82b8dc26e7ed1ebb","27871c54661743e691e6300524c7d589","daf4f2f8bfd045a9be52858406ee8c3a"],"selected_labels":["2270577d8a1d48588ec3fb47514ad698"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline \\multicolumn{2}{|l|}{\\multirow{2}{*}{\\begin{tabular}{l}\nScreening for Potential Mothers of Eligible Infants (GA \\(23-26 \\frac{6}{7}\\) wks): mothers who present in preterm labour \\\\\n1. Neonatal Fellows are asked by clinical obstetric team to consult mothers who present with threatening preterm labour or due to maternal/fetal reason may deliver prematurely \\\\\n2. Neonatal Fellows will contact Study Team \\\\\n3. Study Team has a discussion with mother/family seeking full, informed consent for DR randomization\n\\end{tabular}}} & \\begin{tabular}{l}\nMothers Entering Preterm Labor within 23-26 week eligibility window (delivery is imminent) \\\\\n1. Due to time restraints, these mothers will not be approached for consent \\\\\n2. Routine data collection (no PHI). ***\n\\end{tabular} \\\\\n\\hline & & \\\\\n\\hline \\multicolumn{3}{|r|}{\\begin{tabular}{l}\n![](https://cdn.mathpix.com/cropped/0acb697e-f405-4a6e-b315-cce91483f079-40.jpg?height=167\\&width=860\\&top_left_y=876\\&top_left_x=567) \\\\\nConsent for SAIL Study Granted \\\\\nConsent for SAIL Study Granted \\\\\nL \\\\\n1. Research team assesses whether preterm delivery proceeds or is halted. \\\\\n2. Progress of pregnancy followed as per clinical routine : L\\&D as well Neo Fellows locked offices will include the Fellows locked offices will include the date in which the fetus/infant will reach 27 wks GA, thereby becoming ineligible. \\\\\n3. There are 3 possible scenarios: L\n\\[\n\\begin{aligned}\n& \\text { Refusal of Consent } \\\\\n& \\text { 1. There will be no further interaction of study team } \\\\\n& \\text { members with family. } \\\\\n& \\text { 2. The Neonatal Team as well as L\\&D team will be } \\\\\n& \\text { notified if consent was obtained/refused. There will } \\\\\n& \\text { be a note placed in mother's chart as well as the } \\\\\n& \\text { bulletin board in the Neonatal Fellows office (locked } \\\\\n& \\text { office) } \\\\\n& \\text { 3. If infant delivers < } 27 \\text { weeks GA, routine data } \\\\\n& \\text { collection (no PHI) }{ }^{* * *}\n\\end{aligned}\n\\]\n\\end{tabular}} \\\\\n\\hline ![](https://cdn.mathpix.com/cropped/0acb697e-f405-4a6e-b315-cce91483f079-40.jpg?height=568\\&width=573\\&top_left_y=1725\\&top_left_x=190) & & \\begin{tabular}{l}\nScenario C: Mothers who are admitted, released and readmitted within the window of eligibility \\\\\n1.If time permits, the study team will meet with mother to re-affirm her decision to participate in the study. \\\\\n2.Study team will document discussions in medical chart \\\\\n3.Study team will remind L\\&D and Neo Fellows of mother's enrollment in study enolinent study\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Figure 3: Screening and Consent Process Outline}\n\\begin{tabular}{|l|l|l|}\n\\hline \\multicolumn{2}{|l|}{\\multirow{2}{*}{\\begin{tabular}{l}\nScreening for Potential Mothers of Eligible Infants (GA \\(23-26 \\frac{6}{7}\\) wks): mothers who present in preterm labour \\\\\n1. Neonatal Fellows are asked by clinical obstetric team to consult mothers who present with threatening preterm labour or due to maternal/fetal reason may deliver prematurely \\\\\n2. Neonatal Fellows will contact Study Team \\\\\n3. Study Team has a discussion with mother/family seeking full, informed consent for DR randomization\n\\end{tabular}}} & \\begin{tabular}{l}\nMothers Entering Preterm Labor within 23-26 week eligibility window (delivery is imminent) \\\\\n1. Due to time restraints, these mothers will not be approached for consent \\\\\n2. Routine data collection (no PHI). ***\n\\end{tabular} \\\\\n\\hline & & \\\\\n\\hline \\multicolumn{3}{|r|}{\\begin{tabular}{l}\n![](https://cdn.mathpix.com/cropped/0acb697e-f405-4a6e-b315-cce91483f079-40.jpg?height=167\\&width=860\\&top_left_y=876\\&top_left_x=567) \\\\\nConsent for SAIL Study Granted \\\\\nConsent for SAIL Study Granted \\\\\nL \\\\\n1. Research team assesses whether preterm delivery proceeds or is halted. \\\\\n2. Progress of pregnancy followed as per clinical routine : L\\&D as well Neo Fellows locked offices will include the Fellows locked offices will include the date in which the fetus/infant will reach 27 wks GA, thereby becoming ineligible. \\\\\n3. There are 3 possible scenarios: L\n\\[\n\\begin{aligned}\n& \\text { Refusal of Consent } \\\\\n& \\text { 1. There will be no further interaction of study team } \\\\\n& \\text { members with family. } \\\\\n& \\text { 2. The Neonatal Team as well as L\\&D team will be } \\\\\n& \\text { notified if consent was obtained/refused. There will } \\\\\n& \\text { be a note placed in mother's chart as well as the } \\\\\n& \\text { bulletin board in the Neonatal Fellows office (locked } \\\\\n& \\text { office) } \\\\\n& \\text { 3. If infant delivers < } 27 \\text { weeks GA, routine data } \\\\\n& \\text { collection (no PHI) }{ }^{* * *}\n\\end{aligned}\n\\]\n\\end{tabular}} \\\\\n\\hline ![](https://cdn.mathpix.com/cropped/0acb697e-f405-4a6e-b315-cce91483f079-40.jpg?height=568\\&width=573\\&top_left_y=1725\\&top_left_x=190) & & \\begin{tabular}{l}\nScenario C: Mothers who are admitted, released and readmitted within the window of eligibility \\\\\n1.If time permits, the study team will meet with mother to re-affirm her decision to participate in the study. \\\\\n2.Study team will document discussions in medical chart \\\\\n3.Study team will remind L\\&D and Neo Fellows of mother's enrollment in study enolinent study\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.614933967590332,"confidence_rate":0.998200730308814},{"cnt":[[195,300],[754,300],[754,2342],[195,2342]],"region":{"top_left_x":194,"top_left_y":300,"width":560,"height":2043},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b897dd15f88c4f0a9a1e03d2bb6ccb33","type":"table_column","conversion_output":false,"parent_id":"03cc32e9cfbc4ec39453bdebc216ed01","text":"","text_display":""},{"cnt":[[784,300],[1219,300],[1222,2342],[787,2342]],"region":{"top_left_x":784,"top_left_y":299,"width":438,"height":2044},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aa087e7e9b9b420e90743f0d7880d948","type":"table_column","conversion_output":false,"parent_id":"03cc32e9cfbc4ec39453bdebc216ed01","text":"","text_display":""},{"cnt":[[1332,300],[1856,300],[1856,2344],[1332,2344]],"region":{"top_left_x":1331,"top_left_y":300,"width":525,"height":2045},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"48efdc216c0441d592e75fd099de2361","type":"table_column","conversion_output":false,"parent_id":"03cc32e9cfbc4ec39453bdebc216ed01","text":"","text_display":""},{"cnt":[[184,309],[1884,309],[1884,783],[184,783]],"region":{"top_left_x":184,"top_left_y":308,"width":1700,"height":475},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"88eb9c15905942688e87616adb7e0200","type":"table_row","conversion_output":false,"parent_id":"03cc32e9cfbc4ec39453bdebc216ed01","text":"","text_display":""},{"cnt":[[184,776],[1884,776],[1884,883],[184,883]],"region":{"top_left_x":184,"top_left_y":776,"width":1700,"height":107},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d5bc1f7666a94a9e88505961864e90b2","type":"table_row","conversion_output":false,"parent_id":"03cc32e9cfbc4ec39453bdebc216ed01","text":"","text_display":""},{"cnt":[[184,1030],[1884,1030],[1884,1491],[184,1491]],"region":{"top_left_x":184,"top_left_y":1029,"width":1700,"height":463},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e296cf767b3e49d197048fa1bcf4b896","type":"table_row","conversion_output":false,"parent_id":"03cc32e9cfbc4ec39453bdebc216ed01","text":"","text_display":""},{"cnt":[[184,1725],[1884,1725],[1884,2323],[184,2323]],"region":{"top_left_x":184,"top_left_y":1724,"width":1700,"height":599},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1f21aad68888409b8e67eafdd07b29ec","type":"table_row","conversion_output":false,"parent_id":"03cc32e9cfbc4ec39453bdebc216ed01","text":"","text_display":""},{"cnt":[[206,317],[1115,317],[1115,878],[206,878]],"region":{"top_left_x":205,"top_left_y":317,"width":911,"height":562},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"729a1650b6f14ce6861042fa8f013c9a","type":"table_spanning_cell","conversion_output":false,"parent_id":"03cc32e9cfbc4ec39453bdebc216ed01","children_ids":["00a135c96afa4826b558a2ad43d96901"],"text":"","text_display":"\\begin{tabular}{l}\nScreening for Potential Mothers of Eligible Infants (GA \\(23-26 \\frac{6}{7}\\) wks): mothers who present in preterm labour \\\\\n1. Neonatal Fellows are asked by clinical obstetric team to consult mothers who present with threatening preterm labour or due to maternal/fetal reason may deliver prematurely \\\\\n2. Neonatal Fellows will contact Study Team \\\\\n3. Study Team has a discussion with mother/family seeking full, informed consent for DR randomization\n\\end{tabular}","cell_row":0,"cell_column":0,"cell_row_span":2,"cell_col_span":2},{"cnt":[[206,319],[1113,319],[1113,876],[206,876]],"region":{"top_left_x":205,"top_left_y":319,"width":908,"height":558},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"00a135c96afa4826b558a2ad43d96901","type":"complex_cell","conversion_output":false,"parent_id":"729a1650b6f14ce6861042fa8f013c9a","children_ids":["bb9751747e7e467481ffd4d833328cb8","9130cdb715694fd0b8a69b71fc9caff9","ed568e2781814518a37cc65122eda145","b6f3f35d183348248faf54294bdb72a3","227bb81186954df2bedc54c304adf874","4231ebec388247bf9e9328e82ff7f94b","800c2cd15acc4dfabb6ee428d721a84a","22455fdebebe4096bedf255674aa9657","34afaa580da348949b3ff969ee72689d","c69f349f8c50453c85602b72d9943f96"],"text":"\\begin{tabular}{l}\nScreening for Potential Mothers of Eligible Infants (GA \\(23-26 \\frac{6}{7}\\) wks): mothers who present in preterm labour \\\\\n1. Neonatal Fellows are asked by clinical obstetric team to consult mothers who present with threatening preterm labour or due to maternal/fetal reason may deliver prematurely \\\\\n2. Neonatal Fellows will contact Study Team \\\\\n3. Study Team has a discussion with mother/family seeking full, informed consent for DR randomization\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nScreening for Potential Mothers of Eligible Infants (GA \\(23-26 \\frac{6}{7}\\) wks): mothers who present in preterm labour \\\\\n1. Neonatal Fellows are asked by clinical obstetric team to consult mothers who present with threatening preterm labour or due to maternal/fetal reason may deliver prematurely \\\\\n2. Neonatal Fellows will contact Study Team \\\\\n3. Study Team has a discussion with mother/family seeking full, informed consent for DR randomization\n\\end{tabular}","cell_row":0,"cell_column":0,"cell_row_span":2,"cell_col_span":2,"confidence":0.48878317460314225,"confidence_rate":0.9986462118832139},{"cnt":[[210,322],[1087,322],[1087,365],[210,365]],"region":{"top_left_x":209,"top_left_y":321,"width":879,"height":44},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bb9751747e7e467481ffd4d833328cb8","type":"text","conversion_output":false,"parent_id":"00a135c96afa4826b558a2ad43d96901","text":"Screening for Potential Mothers of Eligible Infants (GA","text_display":"Screening for Potential Mothers of Eligible Infants (GA","confidence":0.9975605006329715,"confidence_rate":0.9999592928319966},{"cnt":[[210,365],[1026,365],[1026,408],[210,408]],"region":{"top_left_x":209,"top_left_y":364,"width":818,"height":45},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9130cdb715694fd0b8a69b71fc9caff9","type":"text","conversion_output":false,"parent_id":"00a135c96afa4826b558a2ad43d96901","text":"\\(23-26 \\frac{6}{7}\\) wks): mothers who present in preterm","text_display":" \\(23-26 \\frac{6}{7}\\) wks): mothers who present in preterm","confidence":0.48878317460314225,"confidence_rate":0.9865844562601508},{"cnt":[[210,413],[325,413],[325,447],[210,447]],"region":{"top_left_x":209,"top_left_y":412,"width":116,"height":36},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ed568e2781814518a37cc65122eda145","type":"text","conversion_output":false,"parent_id":"00a135c96afa4826b558a2ad43d96901","text":"labour","text_display":" labour","confidence":1,"confidence_rate":1},{"cnt":[[210,491],[1087,491],[1087,534],[210,534]],"region":{"top_left_x":209,"top_left_y":490,"width":879,"height":44},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b6f3f35d183348248faf54294bdb72a3","type":"text","conversion_output":false,"parent_id":"00a135c96afa4826b558a2ad43d96901","text":"1. Neonatal Fellows are asked by clinical obstetric team","text_display":"\n1. Neonatal Fellows are asked by clinical obstetric team","confidence":1,"confidence_rate":1},{"cnt":[[210,534],[1070,534],[1070,579],[210,579]],"region":{"top_left_x":209,"top_left_y":533,"width":861,"height":47},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"227bb81186954df2bedc54c304adf874","type":"text","conversion_output":false,"parent_id":"00a135c96afa4826b558a2ad43d96901","text":"to consult mothers who present with threatening pre-","text_display":" to consult mothers who present with threatening pre","confidence":1,"confidence_rate":1},{"cnt":[[210,579],[1109,579],[1109,623],[210,623]],"region":{"top_left_x":209,"top_left_y":579,"width":900,"height":44},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4231ebec388247bf9e9328e82ff7f94b","type":"text","conversion_output":false,"parent_id":"00a135c96afa4826b558a2ad43d96901","text":"term labour or due to maternal/fetal reason may deliver","text_display":"term labour or due to maternal/fetal reason may deliver","confidence":1,"confidence_rate":1},{"cnt":[[210,625],[420,625],[420,670],[210,670]],"region":{"top_left_x":209,"top_left_y":624,"width":212,"height":47},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"800c2cd15acc4dfabb6ee428d721a84a","type":"text","conversion_output":false,"parent_id":"00a135c96afa4826b558a2ad43d96901","text":"prematurely","text_display":" prematurely","confidence":1,"confidence_rate":1},{"cnt":[[210,705],[914,705],[914,748],[210,748]],"region":{"top_left_x":209,"top_left_y":704,"width":705,"height":45},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"22455fdebebe4096bedf255674aa9657","type":"text","conversion_output":false,"parent_id":"00a135c96afa4826b558a2ad43d96901","text":"2. 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Study Team has a discussion with mother/family","confidence":1,"confidence_rate":1},{"cnt":[[210,828],[1039,828],[1039,874],[210,874]],"region":{"top_left_x":209,"top_left_y":828,"width":831,"height":46},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c69f349f8c50453c85602b72d9943f96","type":"text","conversion_output":false,"parent_id":"00a135c96afa4826b558a2ad43d96901","text":"seeking full, informed consent for DR randomization","text_display":" seeking full, informed consent for DR randomization","confidence":1,"confidence_rate":1},{"cnt":[[1410,335],[1849,335],[1849,746],[1410,746]],"region":{"top_left_x":1409,"top_left_y":334,"width":441,"height":413},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9562c681c9e54bdebabca3c255bd1325","type":"complex_cell","conversion_output":false,"parent_id":"03cc32e9cfbc4ec39453bdebc216ed01","children_ids":["68deefd9e91c4004a4ae8d66e7dfc7af","719629e6af59437ca2cb3565389011fc","5063854d95514650a3c2eea58ea4cd1f","84316dab29fb45a5ac859a499fbb125b","2eed44bd9b4845fc8cc932832225da40","050e151b5eef486e9228a7ebc0db4445","fcf00ff421354a18a0f2d5fa8fdf3e04","8ae454d415c64c9cad1ca4f942cdb3cc","b93ec4ba47d14ae08e73d7ee8e747dfc"],"text":"\\begin{tabular}{l}\nMothers Entering Preterm Labor within 23-26 week eligibility window (delivery is imminent) \\\\\n1. Due to time restraints, these mothers will not be approached for consent \\\\\n2. Routine data collection (no PHI). ***\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nMothers Entering Preterm Labor within 23-26 week eligibility window (delivery is imminent) \\\\\n1. Due to time restraints, these mothers will not be approached for consent \\\\\n2. 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Research team assesses whether preterm delivery proceeds or is halted. \\\\\n2. Progress of pregnancy followed as per clinical routine : L\\&D as well Neo Fellows locked offices will include the Fellows locked offices will include the date in which the fetus/infant will reach 27 wks GA, thereby becoming ineligible. \\\\\n3. There are 3 possible scenarios: L\n\\[\n\\begin{aligned}\n& \\text { Refusal of Consent } \\\\\n& \\text { 1. There will be no further interaction of study team } \\\\\n& \\text { members with family. } \\\\\n& \\text { 2. The Neonatal Team as well as L\\&D team will be } \\\\\n& \\text { notified if consent was obtained/refused. There will } \\\\\n& \\text { be a note placed in mother's chart as well as the } \\\\\n& \\text { bulletin board in the Neonatal Fellows office (locked } \\\\\n& \\text { office) } \\\\\n& \\text { 3. If infant delivers < } 27 \\text { weeks GA, routine data } \\\\\n& \\text { collection (no PHI) }{ }^{* * *}\n\\end{aligned}\n\\]\n\\end{tabular}","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":3},{"cnt":[[248,876],[1845,876],[1845,1489],[248,1489]],"region":{"top_left_x":248,"top_left_y":876,"width":1597,"height":613},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d25fc26feac441ea2a885c834bd309e","type":"complex_cell","conversion_output":false,"parent_id":"ba0fc3ed68be410d82b8dc26e7ed1ebb","children_ids":["ad1fec8a85b244feac363485b27551ef","1fe4e30e8f554e14ad7a535badf59000","b6565da04322400bb29bd8cb410af198","2c63873b7a6945e88c63346d35b57c2b","4182264539f94ae8825ba1a374a0e2e3","ec5c35dfb9904f0580c18aa62944a28c"],"text":"\\begin{tabular}{l}\n![](https://cdn.mathpix.com/cropped/0acb697e-f405-4a6e-b315-cce91483f079-40.jpg?height=167\\&width=860\\&top_left_y=876\\&top_left_x=567) \\\\\nConsent for SAIL Study Granted \\\\\nConsent for SAIL Study Granted \\\\\nL \\\\\n1. Research team assesses whether preterm delivery proceeds or is halted. \\\\\n2. Progress of pregnancy followed as per clinical routine : L\\&D as well Neo Fellows locked offices will include the Fellows locked offices will include the date in which the fetus/infant will reach 27 wks GA, thereby becoming ineligible. \\\\\n3. There are 3 possible scenarios: L\n\\[\n\\begin{aligned}\n& \\text { Refusal of Consent } \\\\\n& \\text { 1. There will be no further interaction of study team } \\\\\n& \\text { members with family. } \\\\\n& \\text { 2. The Neonatal Team as well as L\\&D team will be } \\\\\n& \\text { notified if consent was obtained/refused. There will } \\\\\n& \\text { be a note placed in mother's chart as well as the } \\\\\n& \\text { bulletin board in the Neonatal Fellows office (locked } \\\\\n& \\text { office) } \\\\\n& \\text { 3. If infant delivers < } 27 \\text { weeks GA, routine data } \\\\\n& \\text { collection (no PHI) }{ }^{* * *}\n\\end{aligned}\n\\]\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n![](https://cdn.mathpix.com/cropped/0acb697e-f405-4a6e-b315-cce91483f079-40.jpg?height=167\\&width=860\\&top_left_y=876\\&top_left_x=567) \\\\\nConsent for SAIL Study Granted \\\\\nConsent for SAIL Study Granted \\\\\nL \\\\\n1. Research team assesses whether preterm delivery proceeds or is halted. \\\\\n2. Progress of pregnancy followed as per clinical routine : L\\&D as well Neo Fellows locked offices will include the Fellows locked offices will include the date in which the fetus/infant will reach 27 wks GA, thereby becoming ineligible. \\\\\n3. There are 3 possible scenarios: L\n\\[\n\\begin{aligned}\n& \\text { Refusal of Consent } \\\\\n& \\text { 1. There will be no further interaction of study team } \\\\\n& \\text { members with family. } \\\\\n& \\text { 2. The Neonatal Team as well as L\\&D team will be } \\\\\n& \\text { notified if consent was obtained/refused. There will } \\\\\n& \\text { be a note placed in mother's chart as well as the } \\\\\n& \\text { bulletin board in the Neonatal Fellows office (locked } \\\\\n& \\text { office) } \\\\\n& \\text { 3. If infant delivers < } 27 \\text { weeks GA, routine data } \\\\\n& \\text { collection (no PHI) }{ }^{* * *}\n\\end{aligned}\n\\]\n\\end{tabular}","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":3,"confidence":0.08953324811714936,"confidence_rate":0.903878656500598},{"cnt":[[567,876],[1427,876],[1427,1043],[567,1043]],"region":{"top_left_x":567,"top_left_y":876,"width":860,"height":167},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ad1fec8a85b244feac363485b27551ef","type":"diagram","conversion_output":false,"parent_id":"4d25fc26feac441ea2a885c834bd309e","text":"","text_display":"![](https://cdn.mathpix.com/cropped/0acb697e-f405-4a6e-b315-cce91483f079-40.jpg?height=167\\&width=860\\&top_left_y=876\\&top_left_x=567)"},{"cnt":[[258,1036],[767,1036],[767,1082],[258,1082]],"region":{"top_left_x":257,"top_left_y":1036,"width":510,"height":46},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1fe4e30e8f554e14ad7a535badf59000","type":"text","conversion_output":false,"parent_id":"4d25fc26feac441ea2a885c834bd309e","text":"Consent for SAIL Study Granted","text_display":"\nConsent for SAIL Study Granted","confidence":0.99951171875,"confidence_rate":0.9999860457974148},{"cnt":[[249,1036],[775,1036],[775,1082],[249,1082]],"region":{"top_left_x":248,"top_left_y":1036,"width":528,"height":46},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b6565da04322400bb29bd8cb410af198","type":"text","conversion_output":false,"parent_id":"4d25fc26feac441ea2a885c834bd309e","text":"Consent for SAIL Study Granted","text_display":"\nConsent for SAIL Study Granted","confidence":0.99951171875,"confidence_rate":0.9999860457974148},{"cnt":[[907,1038],[996,1038],[996,1060],[907,1060]],"region":{"top_left_x":907,"top_left_y":1038,"width":90,"height":23},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2c63873b7a6945e88c63346d35b57c2b","type":"text","conversion_output":false,"parent_id":"4d25fc26feac441ea2a885c834bd309e","text":"L","text_display":"\nL","confidence":0.08953324811714936,"confidence_rate":0.6688530678101869},{"cnt":[[255,1077],[878,1077],[878,1488],[255,1488]],"region":{"top_left_x":255,"top_left_y":1077,"width":623,"height":411},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4182264539f94ae8825ba1a374a0e2e3","type":"column","conversion_output":false,"parent_id":"4d25fc26feac441ea2a885c834bd309e","children_ids":["e33f552861b74c5cb8a1b1734c7b6e12","a57268c8eabe4df9bb88349ab27472ef","4792c9a95bdf4a0cba027bc9950a3f5b","8844afe9cd5d479b9904594761fc7571","428a23ad7be44672acb850be418abb7b","a4d8bc96f71b40a68c35c2d138c89ae5","952051fe652c43928877089666c6013a","4b25213fe42e4de49f8cac0e7c6f3903","db24c037fa37440194df0c706759e610","d8440a40569c469db1daef977fe54189","e5bbb8b3bf464cc58634ef4cc850b186"],"text":"","text_display":""},{"cnt":[[258,1080],[823,1080],[823,1116],[258,1116]],"region":{"top_left_x":257,"top_left_y":1079,"width":566,"height":38},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e33f552861b74c5cb8a1b1734c7b6e12","type":"text","conversion_output":false,"parent_id":"4182264539f94ae8825ba1a374a0e2e3","text":"1. 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There will be no further interaction of study team } \\\\\n& \\text { members with family. } \\\\\n& \\text { 2. The Neonatal Team as well as L\\&D team will be } \\\\\n& \\text { notified if consent was obtained/refused. There will } \\\\\n& \\text { be a note placed in mother's chart as well as the } \\\\\n& \\text { bulletin board in the Neonatal Fellows office (locked } \\\\\n& \\text { office) } \\\\\n& \\text { 3. If infant delivers < } 27 \\text { weeks GA, routine data } \\\\\n& \\text { collection (no PHI) }{ }^{* * *}\n\\end{aligned}\n\\]","text_display":"\n\\[\n\\begin{aligned}\n& \\text { Refusal of Consent } \\\\\n& \\text { 1. There will be no further interaction of study team } \\\\\n& \\text { members with family. } \\\\\n& \\text { 2. The Neonatal Team as well as L\\&D team will be } \\\\\n& \\text { notified if consent was obtained/refused. 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If infant delivers < } 27 \\text { weeks GA, routine data } \\\\\n& \\text { collection (no PHI) }{ }^{* * 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[ see Table in section 4.5.3]","text_display":"\n\n\\footnotetext{\n*** IRB approval will be obtained for data collection. [ see Table in section 4.5.3]\n}","confidence":0.9815403388347477,"confidence_rate":0.9997906717218761},{"cnt":[[1904,2643],[1959,2643],[1959,2696],[1904,2696]],"region":{"top_left_x":1903,"top_left_y":2642,"width":57,"height":55},"line":88,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"431129eb130d443eb1c8ece0d7329427","type":"page_info","conversion_output":false,"text":"40","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-41","page":41,"lines":[{"cnt":[[168,62],[1222,62],[1222,116],[168,116]],"region":{"top_left_x":167,"top_left_y":62,"width":1056,"height":55},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a6556958edc466794be2fd1c4e89e30","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) Study","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1491,62],[1916,62],[1916,114],[1491,114]],"region":{"top_left_x":1491,"top_left_y":62,"width":426,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aada763b0db24c22bc5c31b9a5362cd6","type":"page_info","conversion_output":false,"text":"Version 2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[161,168],[819,168],[819,236],[161,236]],"region":{"top_left_x":161,"top_left_y":167,"width":658,"height":70},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea1308412f1d4d28906f83ec558c4369","type":"section_header","conversion_output":false,"children_ids":["ad4ae3ccd7ed40b6bfc427f806bb62ba"],"text":"","text_display":""},{"cnt":[[168,176],[814,176],[814,230],[168,230]],"region":{"top_left_x":167,"top_left_y":176,"width":648,"height":54},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad4ae3ccd7ed40b6bfc427f806bb62ba","type":"text","conversion_output":true,"parent_id":"ea1308412f1d4d28906f83ec558c4369","text":"8.2. Risks of Study Participation","text_display":"\n\n\\subsection*{8.2. Risks of Study Participation}","confidence":0.9228515625,"confidence_rate":0.997889417835679},{"cnt":[[168,245],[1871,245],[1871,299],[168,299]],"region":{"top_left_x":167,"top_left_y":244,"width":1705,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d1c4d7710df41069ee7c0953a97ebf3","type":"text","conversion_output":true,"text":"The main risk of this maneuver is occurence of pneumothorax (air-leak). [Pneumothorax is the most","text_display":"\n\nThe main risk of this maneuver is occurence of pneumothorax (air-leak). 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While this risk is described in relation to the experimental","text_display":" as potential complications (see section 9.2.3)]. 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It is therefore explicitly acknowledged as a risk in the Newborn Resuscitation Program","text_display":" resuscitation. 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It is relevant","text_display":" Edition 2011; Editor J.Kattwinkel. \\({ }^{4}\\) [Page numbers in the next paragraph refer to this text]. It is relevant","confidence":1,"confidence_rate":1},{"cnt":[[165,655],[1940,655],[1940,709],[165,709]],"region":{"top_left_x":165,"top_left_y":655,"width":1776,"height":54},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2fdd3aabed842cab9846e371a35f2d0","type":"text","conversion_output":true,"text":"that all care-givers whether in the USA, Canada, Europe or Australia (where the SAIL recruiting sites are)","text_display":" that all care-givers whether in the USA, Canada, Europe or Australia (where the SAIL recruiting sites are)","confidence":1,"confidence_rate":1},{"cnt":[[168,715],[1871,715],[1871,767],[168,767]],"region":{"top_left_x":167,"top_left_y":715,"width":1705,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a90f7ed9b9094f94b2e9ef11a50728fe","type":"text","conversion_output":true,"text":"are required to have successfully completed an NRP course or equivalent, in order to deliver care to","text_display":" are required to have successfully completed an NRP course or equivalent, in order to deliver care to","confidence":1,"confidence_rate":1},{"cnt":[[168,773],[410,773],[410,821],[168,821]],"region":{"top_left_x":167,"top_left_y":773,"width":244,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"929cb58d48524325821afeaf993ec1ed","type":"text","conversion_output":true,"text":"these infants.","text_display":" these infants.","confidence":1,"confidence_rate":1},{"cnt":[[165,866],[1940,866],[1940,917],[165,917]],"region":{"top_left_x":165,"top_left_y":865,"width":1776,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"447f2ae2f9c64727a77df513c56982cd","type":"text","conversion_output":true,"text":"The main predisposing etiological factor for pneumothorax is widely acknowledged to be the amount of","text_display":"\n\nThe main predisposing etiological factor for pneumothorax is widely acknowledged to be the amount of","confidence":1,"confidence_rate":1},{"cnt":[[168,924],[1394,924],[1394,978],[168,978]],"region":{"top_left_x":167,"top_left_y":923,"width":1228,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f89dfa804022478ca86d81fb5ddf5675","type":"text","conversion_output":true,"text":"airway pressure delivered to the lungs. As written in the NRP Guideline:","text_display":" airway pressure delivered to the lungs. As written in the NRP Guideline:","confidence":1,"confidence_rate":1},{"cnt":[[296,1018],[1695,1018],[1695,1072],[296,1072]],"region":{"top_left_x":296,"top_left_y":1018,"width":1400,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1fbe6f98371f479fb5977b437e940af7","type":"text","conversion_output":true,"text":"\"inadvertent high-inflating pressures being delivered to the patient may result in a","text_display":"\n\"inadvertent high-inflating pressures being delivered to the patient may result in a","confidence":1,"confidence_rate":1},{"cnt":[[305,1079],[685,1079],[685,1130],[305,1130]],"region":{"top_left_x":305,"top_left_y":1078,"width":381,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a090a579d7c24787b4c3073f29ace74f","type":"text","conversion_output":true,"text":"pneumothorax\" p.82;","text_display":" pneumothorax\" p.82;","confidence":1,"confidence_rate":1},{"cnt":[[296,1169],[1682,1169],[1682,1222],[296,1222]],"region":{"top_left_x":296,"top_left_y":1168,"width":1387,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb2c9617c014402685fdbe7125ef48ac","type":"text","conversion_output":true,"text":"\"high pressure may be generated in the baby and cause a pneumothorax or other","text_display":"\n\"high pressure may be generated in the baby and cause a pneumothorax or other","confidence":1,"confidence_rate":1},{"cnt":[[305,1229],[587,1229],[587,1278],[305,1278]],"region":{"top_left_x":305,"top_left_y":1228,"width":282,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"540a24f674294704b13fce6afe45f9c7","type":"text","conversion_output":true,"text":"air-leak\" p.117;","text_display":" air-leak\" p.117;","confidence":0.99755859375,"confidence_rate":0.9998836071864655},{"cnt":[[296,1319],[1695,1319],[1695,1373],[296,1373]],"region":{"top_left_x":296,"top_left_y":1319,"width":1400,"height":54},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"75093745bb2b478a9376d4021994449b","type":"text","conversion_output":true,"text":"\"Sufficient pressure to achieve a rise in heart rate and adequate ventilation should","text_display":"\n\"Sufficient pressure to achieve a rise in heart rate and adequate ventilation should","confidence":1,"confidence_rate":1},{"cnt":[[305,1379],[1626,1379],[1626,1433],[305,1433]],"region":{"top_left_x":305,"top_left_y":1379,"width":1322,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"683a04dd63394554939af0c660e64f81","type":"text","conversion_output":true,"text":"be provided, but excessive inflation pressure or too much CPAP can... create a","text_display":" be provided, but excessive inflation pressure or too much CPAP can... create a","confidence":0.9951171875,"confidence_rate":0.9999410285777173},{"cnt":[[305,1439],[703,1439],[703,1491],[305,1491]],"region":{"top_left_x":305,"top_left_y":1439,"width":398,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ae77c5b1a944664a68b56c7156d8447","type":"text","conversion_output":true,"text":"pneumothorax\" p.277.","text_display":" pneumothorax\" p.277.","confidence":0.7657392024993896,"confidence_rate":0.9893802466595254},{"cnt":[[168,1532],[1772,1532],[1772,1583],[168,1583]],"region":{"top_left_x":167,"top_left_y":1531,"width":1606,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f60e94f53d27489aa31f8613b1d93e51","type":"text","conversion_output":true,"text":"NRP also therefore has to proffer a standard treatment for pneumothorax which is outlined in","text_display":"\n\nNRP also therefore has to proffer a standard treatment for pneumothorax which is outlined in","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[168,1590],[518,1590],[518,1644],[168,1644]],"region":{"top_left_x":167,"top_left_y":1589,"width":351,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"087e25389d214c28beed2e87c6b41492","type":"text","conversion_output":true,"text":"considerable depth.","text_display":" considerable depth.","confidence":1,"confidence_rate":1},{"cnt":[[168,1684],[1888,1684],[1888,1738],[168,1738]],"region":{"top_left_x":167,"top_left_y":1684,"width":1722,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"632e7edae6304cb4a9e7b4bd3793b120","type":"text","conversion_output":true,"text":"Accordingly, the NRP recommends that there be pressure limits on the degree of inflation to be used","text_display":"\n\nAccordingly, the NRP recommends that there be pressure limits on the degree of inflation to be used","confidence":1,"confidence_rate":1},{"cnt":[[168,1742],[801,1742],[801,1794],[168,1794]],"region":{"top_left_x":167,"top_left_y":1742,"width":635,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b73e5a562fc4a9cb5d38a06e4115cff","type":"text","conversion_output":true,"text":"during resuscitation of these infants:","text_display":" during resuscitation of these infants:","confidence":1,"confidence_rate":1},{"cnt":[[296,1835],[1586,1835],[1586,1888],[296,1888]],"region":{"top_left_x":296,"top_left_y":1834,"width":1290,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"237c102237c44121a176cf61d8a5fd09","type":"text","conversion_output":true,"text":"\"If positive pressure ventilation is required, use the lowest inflation pressure","text_display":"\n\"If positive pressure ventilation is required, use the lowest inflation pressure","confidence":0.9990234375,"confidence_rate":0.9999885054819704},{"cnt":[[305,1895],[1669,1895],[1669,1949],[305,1949]],"region":{"top_left_x":305,"top_left_y":1894,"width":1365,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a90e3afef354f9283235b3575076833","type":"text","conversion_output":true,"text":"necessary to achieve an adequate response. An initial inflation pressure of 20 to","text_display":" necessary to achieve an adequate response. 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The first SI given is of a pressure of 20 cm H 2 O and the second is a pressure of 25 cm H 2 O .","text_display":" study. The first SI given is of a pressure of 20 cm H 2 O and the second is a pressure of 25 cm H 2 O .","confidence":0.393634935724549,"confidence_rate":0.9926278533466678},{"cnt":[[1901,2643],[1959,2643],[1959,2696],[1901,2696]],"region":{"top_left_x":1901,"top_left_y":2642,"width":59,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb80c826a4b441b0b620a0ddabd1eacb","type":"page_info","conversion_output":false,"text":"41","text_display":"","confidence":0.99951171875,"confidence_rate":0.9997558295653994}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-42","page":42,"lines":[{"cnt":[[168,64],[1218,64],[1218,114],[168,114]],"region":{"top_left_x":167,"top_left_y":64,"width":1052,"height":50},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"415090327e2f4cdb915d79b071b5b308","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) Study","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1495,64],[1914,64],[1914,114],[1495,114]],"region":{"top_left_x":1495,"top_left_y":64,"width":420,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4000f82ebdbb43cfbfec208258b42f29","type":"page_info","conversion_output":false,"text":"Version 2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[172,180],[1858,180],[1858,226],[172,226]],"region":{"top_left_x":171,"top_left_y":180,"width":1688,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1b191838bbc48ef8be6e39726c625e0","type":"text","conversion_output":true,"text":"Finally, in the randomized studies to date there has not been any increase in serious outcomes, like","text_display":"\n\nFinally, in the randomized studies to date there has not been any increase in serious outcomes, like","confidence":1,"confidence_rate":1},{"cnt":[[168,236],[1927,236],[1927,286],[168,286]],"region":{"top_left_x":167,"top_left_y":236,"width":1761,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dacc0039644e47608420f9175bd18fa2","type":"text","conversion_output":true,"text":"death rates, from the sustained inflation maneuver. However, in regard to the main potential risk to be","text_display":" death rates, from the sustained inflation maneuver. However, in regard to the main potential risk to be","confidence":1,"confidence_rate":1},{"cnt":[[168,296],[1678,296],[1678,346],[168,346]],"region":{"top_left_x":167,"top_left_y":296,"width":1511,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3506e44bde0948c0aec730606bd0dd1a","type":"text","conversion_output":true,"text":"discussed, we tabulate below the conflicting data on the rates of airleak in these studies.","text_display":" discussed, we tabulate below the conflicting data on the rates of airleak in these studies.","confidence":1,"confidence_rate":1},{"cnt":[[163,382],[1480,382],[1480,443],[163,443]],"region":{"top_left_x":163,"top_left_y":382,"width":1318,"height":61},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b499112bfc1d41cf823c92dda5beaace","type":"figure_label","conversion_output":false,"text":"Risks of air-leak in randomized studies where two groups can be 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Study & Rates of pneumothorax in control group using standard NRP & Rates of pneumothorax in Sustained inflation group & P values reported \\\\\n\\hline Lindner 2005 & 4/30 (13\\%) & 3/31 (10\\%) & Ns \\\\\n\\hline Te-Pas 2007 & 7/103 (7\\%) & 1/104 (1\\%) & 0.069 \\\\\n\\hline Lista Unpublished 2013 (private communication) & 2/124 & 8/126 & 0.102 \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Risks of air-leak in randomized studies where two groups can be compared}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Study & Rates of pneumothorax in control group using standard NRP & Rates of pneumothorax in Sustained inflation group & P values reported \\\\\n\\hline Lindner 2005 & 4/30 (13\\%) & 3/31 (10\\%) & Ns \\\\\n\\hline Te-Pas 2007 & 7/103 (7\\%) & 1/104 (1\\%) & 0.069 \\\\\n\\hline Lista Unpublished 2013 (private communication) & 2/124 & 8/126 & 0.102 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The DCC reviews forms used at the sites to ensure that essential elements of consent are","text_display":" center. 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The DSMC can recommend further action and the DCC will be responsible for notification","text_display":" necessary. The DSMC can recommend further action and the DCC will be responsible for notification","confidence":1,"confidence_rate":1},{"cnt":[[232,1384],[1824,1384],[1824,1431],[232,1431]],"region":{"top_left_x":232,"top_left_y":1383,"width":1593,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"daa6308f1a8e48998b2510d6d1a8cc38","type":"text","conversion_output":true,"text":"to the local site team and NICHD. NICHD may request the DCC notify required parties through","text_display":" to the local site team and NICHD. NICHD may request the DCC notify required parties through","confidence":1,"confidence_rate":1},{"cnt":[[232,1439],[1291,1439],[1291,1485],[232,1485]],"region":{"top_left_x":232,"top_left_y":1439,"width":1060,"height":46},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aab0176e956642e9a4bdbb4f1ccf7975","type":"text","conversion_output":true,"text":"established communication mechanisms via technical memos.","text_display":" established communication mechanisms via technical memos.","confidence":1,"confidence_rate":1},{"cnt":[[232,1534],[1951,1534],[1951,1583],[232,1583]],"region":{"top_left_x":232,"top_left_y":1533,"width":1719,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2af8bc7286044ef9b5c29ba8a63deaa","type":"text","conversion_output":true,"text":"Reporting to the Food and Drug Administration will not be required for this trial as it involves no new","text_display":"\n\nReporting to the Food and Drug Administration will not be required for this trial as it involves no new","confidence":1,"confidence_rate":1},{"cnt":[[232,1592],[1102,1592],[1102,1639],[232,1639]],"region":{"top_left_x":232,"top_left_y":1591,"width":871,"height":49},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"877038820ca346689a8662465d43247f","type":"text","conversion_output":true,"text":"drug or device intervention mandating an IND/IDE.","text_display":" drug or device intervention mandating an IND/IDE.","confidence":1,"confidence_rate":1},{"cnt":[[168,1710],[505,1710],[505,1772],[168,1772]],"region":{"top_left_x":167,"top_left_y":1710,"width":338,"height":63},"line":24,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"d9b8663b6d9a491d820ed073919c5637","type":"section_header","conversion_output":false,"children_ids":["4ec3c9ee77f84da9ba9c6b0384edaf83"],"text":"","text_display":""},{"cnt":[[172,1714],[501,1714],[501,1772],[172,1772]],"region":{"top_left_x":171,"top_left_y":1714,"width":330,"height":59},"line":25,"column":0,"font_size":44,"is_printed":true,"is_handwritten":false,"id":"4ec3c9ee77f84da9ba9c6b0384edaf83","type":"text","conversion_output":true,"parent_id":"d9b8663b6d9a491d820ed073919c5637","text":"10. Synopsis","text_display":"\n\n\\section*{10. Synopsis}","confidence":1,"confidence_rate":1},{"cnt":[[172,1800],[1824,1800],[1824,1848],[172,1848]],"region":{"top_left_x":171,"top_left_y":1800,"width":1654,"height":48},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"433173eb79434557babfd85531ebf66c","type":"text","conversion_output":true,"text":"It is expected that trial completion in 12 sites will take 5 years, including 2.5 years of recruitment.","text_display":"\n\nIt is expected that trial completion in 12 sites will take 5 years, including 2.5 years of recruitment.","confidence":0.9970715045928955,"confidence_rate":0.9999749337172424},{"cnt":[[168,1893],[1794,1893],[1794,1940],[168,1940]],"region":{"top_left_x":167,"top_left_y":1892,"width":1627,"height":49},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fade2dfda1184c47aed5f7ea80c65699","type":"text","conversion_output":true,"text":"This project has huge public health implications due to large burden from death and BPD in this","text_display":"\nThis project has huge public health implications due to large burden from death and BPD in this","confidence":1,"confidence_rate":1},{"cnt":[[172,1951],[1867,1951],[1867,2000],[172,2000]],"region":{"top_left_x":171,"top_left_y":1950,"width":1696,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2846c7d334a4662bdbe16ed33b3cb52","type":"text","conversion_output":true,"text":"population. The study intervention \\(( SI )\\) is poised to reduce this burden, and the trial would be at the","text_display":" population. The study intervention \\(( SI )\\) is poised to reduce this burden, and the trial would be at the","confidence":0.9912149906158447,"confidence_rate":0.9999219161011211},{"cnt":[[172,2007],[1944,2007],[1944,2056],[172,2056]],"region":{"top_left_x":171,"top_left_y":2006,"width":1774,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b28b3ad8419244889b17a4c7de8d167f","type":"text","conversion_output":true,"text":"'right time', for a not-yet established therapy with promising pilot data. Moreover the potential benefits","text_display":" 'right time', for a not-yet established therapy with promising pilot data. Moreover the potential benefits","confidence":0.99853515625,"confidence_rate":0.9999867936215969},{"cnt":[[172,2067],[1931,2067],[1931,2116],[172,2116]],"region":{"top_left_x":171,"top_left_y":2066,"width":1761,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c366495dd6440e79b574595c5e74d1e","type":"text","conversion_output":true,"text":"are lifelong, if the strategy is successful. In addition to the outstanding track record and expertise of the","text_display":" are lifelong, if the strategy is successful. In addition to the outstanding track record and expertise of the","confidence":1,"confidence_rate":1},{"cnt":[[172,2127],[1940,2127],[1940,2176],[172,2176]],"region":{"top_left_x":171,"top_left_y":2126,"width":1770,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40ba8db3ccf0405bbcca47e1623638f7","type":"text","conversion_output":true,"text":"US based co-PIs, the overseas co-PIs are essential for successful trial completion. The key benefits of the","text_display":" US based co-PIs, the overseas co-PIs are essential for successful trial completion. The key benefits of the","confidence":0.5945062637329102,"confidence_rate":0.9953676907263612},{"cnt":[[170,2185],[1893,2185],[1893,2232],[170,2232]],"region":{"top_left_x":169,"top_left_y":2184,"width":1724,"height":49},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c789f37e35f14f768bf2774a4341382a","type":"text","conversion_output":true,"text":"foreign sites include content expertise in DR research and sustained inflation. Most of the animal and","text_display":" foreign sites include content expertise in DR research and sustained inflation. Most of the animal and","confidence":1,"confidence_rate":1},{"cnt":[[172,2243],[1910,2243],[1910,2292],[172,2292]],"region":{"top_left_x":171,"top_left_y":2242,"width":1739,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5c3e260936f42b6804db4890b1303c6","type":"text","conversion_output":true,"text":"human data on this novel technique comes almost exclusively from Europe and Australia. Similar large","text_display":" human data on this novel technique comes almost exclusively from Europe and Australia. Similar large","confidence":0.998046875,"confidence_rate":0.9999813807939509},{"cnt":[[172,2303],[1927,2303],[1927,2350],[172,2350]],"region":{"top_left_x":171,"top_left_y":2303,"width":1757,"height":48},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0200b851325d46de9471d8d901b94674","type":"text","conversion_output":true,"text":"scale RCTs (TIPP, CAP, PINT) have been completed internationally. In addition PD is a member of ILCOR,","text_display":" scale RCTs (TIPP, CAP, PINT) have been completed internationally. In addition PD is a member of ILCOR,","confidence":1,"confidence_rate":1},{"cnt":[[172,2359],[1916,2359],[1916,2408],[172,2408]],"region":{"top_left_x":171,"top_left_y":2358,"width":1746,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"156b25811d97430688f05140ba71df70","type":"text","conversion_output":true,"text":"confirming the critical importance of the question and guaranteeing translation to clinical practice. We","text_display":" confirming the critical importance of the question and guaranteeing translation to clinical practice. We","confidence":1,"confidence_rate":1},{"cnt":[[172,2419],[1919,2419],[1919,2469],[172,2469]],"region":{"top_left_x":171,"top_left_y":2419,"width":1748,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69900a97c5b1461387800ea773f90d92","type":"text","conversion_output":true,"text":"submit that the involvement of all these highly committed international sites, but under US leadership,","text_display":" submit that the involvement of all these highly committed international sites, but under US leadership,","confidence":1,"confidence_rate":1},{"cnt":[[172,2477],[1914,2477],[1914,2527],[172,2527]],"region":{"top_left_x":171,"top_left_y":2477,"width":1744,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"538206f8bcb14ffd969922838795a6d8","type":"text","conversion_output":true,"text":"and in collaboration with the US sites - can only further promote the currently high profile of neonatal","text_display":" and in collaboration with the US sites - can only further promote the currently high profile of neonatal","confidence":1,"confidence_rate":1},{"cnt":[[1904,2643],[1955,2643],[1955,2696],[1904,2696]],"region":{"top_left_x":1903,"top_left_y":2642,"width":53,"height":55},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"910a579503524f3f842b59197f3a0a81","type":"page_info","conversion_output":false,"text":"48","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"0acb697e-f405-4a6e-b315-cce91483f079-49","page":49,"lines":[{"cnt":[[168,62],[1222,62],[1222,116],[168,116]],"region":{"top_left_x":167,"top_left_y":62,"width":1056,"height":55},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9f5cfafefa646e39a9f760e0df40cee","type":"page_info","conversion_output":false,"text":"The Sustained Aeration of Infant Lungs (SAIL) Study","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1491,62],[1916,62],[1916,114],[1491,114]],"region":{"top_left_x":1491,"top_left_y":62,"width":426,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"22800bebd3454f3c937aa3ed99250507","type":"page_info","conversion_output":false,"text":"Version 2.7_2017315","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[168,176],[1936,176],[1936,230],[168,230]],"region":{"top_left_x":167,"top_left_y":176,"width":1769,"height":54},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"721f6e79f408456186b35fef3c2e0a8a","type":"text","conversion_output":true,"text":"trial research led by the US. A deserved field to further this is Delivery room resuscitation. This has been","text_display":"\ntrial research led by the US. A deserved field to further this is Delivery room resuscitation. This has been","confidence":0.9990234375,"confidence_rate":0.9999913536688149},{"cnt":[[168,234],[1474,234],[1474,286],[168,286]],"region":{"top_left_x":167,"top_left_y":234,"width":1307,"height":52},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36a2983e48b148ddaeef78f00a994b48","type":"text","conversion_output":true,"text":"for too long, a neglected area for randomized trial evidence based medicine.","text_display":" for too long, a neglected area for randomized trial evidence based medicine.","confidence":1,"confidence_rate":1},{"cnt":[[163,352],[561,352],[561,415],[163,415]],"region":{"top_left_x":163,"top_left_y":352,"width":398,"height":63},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3c33f3b981242ea9108337eac02ef34","type":"section_header","conversion_output":false,"children_ids":["bcb6a0a311f6444783e29508237dd509"],"text":"","text_display":""},{"cnt":[[172,357],[552,357],[552,410],[172,410]],"region":{"top_left_x":171,"top_left_y":356,"width":382,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bcb6a0a311f6444783e29508237dd509","type":"text","conversion_output":true,"parent_id":"d3c33f3b981242ea9108337eac02ef34","text":"11. References","text_display":"\n\n\\section*{11. References}","confidence":1,"confidence_rate":1},{"cnt":[[168,443],[1944,443],[1944,494],[168,494]],"region":{"top_left_x":167,"top_left_y":442,"width":1778,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d35723fe3124fa4aff95b8e41db28c0","type":"text","conversion_output":true,"text":"1. Walsh MC, Yao Q, Gettner P, et al. Impact of a physiologic definition on bronchopulmonary dysplasia","text_display":"\n1. Walsh MC, Yao Q, Gettner P, et al. Impact of a physiologic definition on bronchopulmonary dysplasia","confidence":0.955078125,"confidence_rate":0.9995705395757108},{"cnt":[[168,494],[810,494],[810,544],[168,544]],"region":{"top_left_x":167,"top_left_y":494,"width":643,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48f22c4e96bd42e493d221b71f67b858","type":"text","conversion_output":true,"text":"rates. Pediatrics. 2004; 114: 1305-11.","text_display":" rates. Pediatrics. 2004; 114: 1305-11.","confidence":1,"confidence_rate":1},{"cnt":[[168,587],[1910,587],[1910,638],[168,638]],"region":{"top_left_x":167,"top_left_y":586,"width":1743,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"502ffd407a5f4c958001b8c27c5175f0","type":"text","conversion_output":true,"text":"2. Network SSGotEKSNNR, Carlo WA, Finer NN, et al. Target ranges of oxygen saturation in extremely","text_display":"\n2. Network SSGotEKSNNR, Carlo WA, Finer NN, et al. Target ranges of oxygen saturation in extremely","confidence":1,"confidence_rate":1},{"cnt":[[168,638],[1452,638],[1452,690],[168,690]],"region":{"top_left_x":167,"top_left_y":638,"width":1286,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d33e3b396dc54c79aac9935c43402f18","type":"text","conversion_output":true,"text":"preterm infants. The New England journal of medicine. 2010; 362: 1959-69.","text_display":" preterm infants. The New England journal of medicine. 2010; 362: 1959-69.","confidence":1,"confidence_rate":1},{"cnt":[[168,730],[1884,730],[1884,782],[168,782]],"region":{"top_left_x":167,"top_left_y":730,"width":1718,"height":53},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19e2bfe835cc438d9f24b44eb27993c5","type":"text","conversion_output":true,"text":"3. Pfister RH and Soll RF. Initial respiratory support of preterm infants: the role of CPAP, the INSURE","text_display":"\n3. Pfister RH and Soll RF. Initial respiratory support of preterm infants: the role of CPAP, the INSURE","confidence":1,"confidence_rate":1},{"cnt":[[168,782],[1506,782],[1506,831],[168,831]],"region":{"top_left_x":167,"top_left_y":782,"width":1340,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5ba45e73a094d3e85435d12eac30704","type":"text","conversion_output":true,"text":"method, and noninvasive ventilation. Clinics in perinatology. 2012; 39: 459-81.","text_display":" method, and noninvasive ventilation. Clinics in perinatology. 2012; 39: 459-81.","confidence":1,"confidence_rate":1},{"cnt":[[168,872],[1914,872],[1914,926],[168,926]],"region":{"top_left_x":167,"top_left_y":872,"width":1748,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"45aa5ff95ecc402c8df89008416d6eb0","type":"text","conversion_output":true,"text":"4. Kattwinkel J. Neonatal Resuscitation (NRP) Textbook - 6th Edition (English version) - 2010 American","text_display":"\n4. Kattwinkel J. Neonatal Resuscitation (NRP) Textbook - 6th Edition (English version) - 2010 American","confidence":0.9990234375,"confidence_rate":0.9999911178608298},{"cnt":[[165,924],[1863,924],[1863,975],[165,975]],"region":{"top_left_x":165,"top_left_y":923,"width":1698,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f309e483d7b421883eabaeb98410498","type":"text","conversion_output":true,"text":"Academy of Pediatrics and American Heart Association Guidelines for Neonatal Resuscitation. 2011.","text_display":" Academy of Pediatrics and American Heart Association Guidelines for Neonatal Resuscitation. 2011.","confidence":0.9980480668600649,"confidence_rate":0.9999806552302407},{"cnt":[[168,1018],[1893,1018],[1893,1068],[168,1068]],"region":{"top_left_x":167,"top_left_y":1018,"width":1726,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"833b348a10cd4140a8904398b178c287","type":"text","conversion_output":true,"text":"5. Committee on F, Newborn and American Academy of P. Respiratory support in preterm infants at","text_display":"\n5. Committee on F, Newborn and American Academy of P. Respiratory support in preterm infants at","confidence":1,"confidence_rate":1},{"cnt":[[168,1070],[763,1070],[763,1119],[168,1119]],"region":{"top_left_x":167,"top_left_y":1069,"width":596,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0e36686162c4531beced5fd34cf3d19","type":"text","conversion_output":true,"text":"birth. Pediatrics. 2014; 133: 171-4.","text_display":" birth. Pediatrics. 2014; 133: 171-4.","confidence":1,"confidence_rate":1},{"cnt":[[168,1160],[1938,1160],[1938,1212],[168,1212]],"region":{"top_left_x":167,"top_left_y":1160,"width":1771,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"743aebb000534eb6aa2b6745b0a240f8","type":"text","conversion_output":true,"text":"6. 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