{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T13:28:16Z","timestamp":1791206896035,"version":"4.1.0"},"reference-count":8,"publisher":"American Academy of Pediatrics (AAP)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2012,3,1]]},"abstract":"\n BACKGROUND AND OBJECTIVE:<\/jats:title>\n The Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial (SUPPORT) antenatal consent study demonstrated that mothers of infants enrolled in the SUPPORT trial had significantly different demographics and exposure to antenatal steroids compared with mothers of eligible, but not enrolled infants. The objective of this analysis was to compare the outcomes of bronchopulmonary dysplasia, severe retinopathy of prematurity, severe intraventricular hemorrhage or periventricular leukomalacia (IVH\/PVL), death, and death\/severe IVH\/PVL for infants enrolled in SUPPORT in comparison with eligible, but not enrolled infants.<\/jats:p>\n <\/jats:sec>\n \n METHODS:<\/jats:title>\n Perinatal characteristics and neonatal outcomes were compared for enrolled and eligible but not enrolled infants in bivariate analyses. Models were created to test the effect of enrollment in SUPPORT on outcomes, controlling for perinatal characteristics.<\/jats:p>\n <\/jats:sec>\n \n RESULTS:<\/jats:title>\n There were 1316 infants enrolled in SUPPORT; 3053 infants were eligible, but not enrolled. In unadjusted analyses, enrolled infants had significantly lower rates of death before discharge, severe IVH\/PVL, death\/severe IVH\/PVL (all &lt; 0.001), and bronchopulmonary dysplasia (P = .003) in comparison with eligible, but not enrolled infants. The rate of severe retinopathy of prematurity was not significantly different. After adjustment for perinatal factors, enrollment in the trial was not a significant predictor of any of the tested clinical outcomes.<\/jats:p>\n <\/jats:sec>\n \n CONCLUSIONS:<\/jats:title>\n The results of this analysis demonstrate significant outcome differences between enrolled and eligible but not enrolled infants in a trial using antenatal consent, which were likely due to enrollment bias resulting from the antenatal consent process. Additional research and regulatory review need to be conducted to ensure that large moderate-risk trials that require antenatal consent can be conducted in such a way as to ensure the generalizability of results.<\/jats:p>\n <\/jats:sec>","DOI":"10.1542\/peds.2011-2121","type":"journal-article","created":{"date-parts":[[2012,2,28]],"date-time":"2012-02-28T03:54:11Z","timestamp":1330401251000},"page":"480-484","source":"Crossref","is-referenced-by-count":95,"title":["Enrollment of Extremely Low Birth Weight Infants in a Clinical Research Study May Not Be Representative"],"prefix":"10.1542","volume":"129","author":[{"given":"Wade","family":"Rich","sequence":"first","affiliation":[{"name":"University of California at San Diego, San Diego, California;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neil N.","family":"Finer","sequence":"additional","affiliation":[{"name":"University of California at San Diego, San Diego, California;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie G.","family":"Gantz","sequence":"additional","affiliation":[{"name":"Statistics and Epidemiology Unit, RTI International, Rockville, Maryland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nancy S.","family":"Newman","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Rainbow Babies & Children\u2019s Hospital, Case Western Reserve University, Cleveland, Ohio;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angelita M.","family":"Hensman","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Women & Infants Hospital, Brown University, Providence, Rhode Island;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellen C.","family":"Hale","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Emory University School of Medicine, and Children\u2019s Healthcare of Atlanta, Atlanta, Georgia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathy J.","family":"Auten","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Duke University, Durham, North Carolina;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kurt","family":"Schibler","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Cincinnati Children\u2019s Hospital Medical Center and University of Cincinnati, Cincinnati, Ohio;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger G.","family":"Faix","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City, Utah; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abbot R.","family":"Laptook","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Emory University School of Medicine, and Children\u2019s Healthcare of Atlanta, Atlanta, Georgia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bradley A.","family":"Yoder","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City, Utah; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abhik","family":"Das","sequence":"additional","affiliation":[{"name":"Statistics and Epidemiology Unit, RTI International, Rockville, Maryland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seetha","family":"Shankaran","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Wayne State University, Detroit, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the SUPPORT and Generic Database Subcommittees of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"417","published-online":{"date-parts":[[2012,3,1]]},"reference":[{"issue":"21","key":"2021120903033769000_B1","doi-asserted-by":"crossref","first-page":"1970","DOI":"10.1056\/NEJMoa0911783","article-title":"Early CPAP versus surfactant in extremely preterm infants","volume":"362","author":"Finer","year":"2010","journal-title":"N Engl J Med"},{"issue":"21","key":"2021120903033769000_B2","doi-asserted-by":"crossref","first-page":"1959","DOI":"10.1056\/NEJMoa0911781","article-title":"Target ranges of oxygen saturation in extremely preterm infants","volume":"362","author":"Carlo","year":"2010","journal-title":"N Engl J Med"},{"issue":"1","key":"2021120903033769000_B3","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2009-3353","article-title":"Antenatal consent in the SUPPORT trial: challenges, costs, and representative enrollment","volume":"126","author":"Rich","year":"2010","journal-title":"Pediatrics"},{"issue":"2","key":"2021120903033769000_B4","doi-asserted-by":"crossref","first-page":"151","DOI":"10.1016\/S0022-3476(99)70428-2","article-title":"Do sick newborn infants benefit from participation in a randomized clinical trial?","volume":"134","author":"Schmidt","year":"1999","journal-title":"J Pediatr"},{"issue":"7","key":"2021120903033769000_B5","doi-asserted-by":"crossref","first-page":"1710","DOI":"10.1002\/1097-0142(19851001)56:7<1710::AID-CNCR2820560741>3.0.CO;2-T","article-title":"Participants in prospective, randomized clinical trials for resected non-small cell lung cancer have improved survival compared with nonparticipants in such trials","volume":"56","author":"Davis","year":"1985","journal-title":"Cancer"},{"key":"2021120903033769000_B6"},{"issue":"10","key":"2021120903033769000_B7","doi-asserted-by":"crossref","first-page":"804","DOI":"10.1056\/NEJM199903113401013","article-title":"Is informed consent always necessary for randomized, controlled trials?","volume":"340","author":"Truog","year":"1999","journal-title":"N Engl J Med"},{"key":"2021120903033769000_B8","doi-asserted-by":"crossref","first-page":"S153","DOI":"10.1097\/01.CCM.0000054901.80339.01","article-title":"Is the concept of informed consent applicable to clinical research involving critically ill patients?","volume":"31","author":"Luce","year":"2003","journal-title":"Crit Care Med"}],"container-title":["Pediatrics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/publications.aap.org\/pediatrics\/article-pdf\/129\/3\/480\/1057544\/peds_2011-2121.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/publications.aap.org\/pediatrics\/article-pdf\/129\/3\/480\/1057544\/peds_2011-2121.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,12,9]],"date-time":"2021-12-09T16:42:19Z","timestamp":1639068139000},"score":1,"resource":{"primary":{"URL":"https:\/\/publications.aap.org\/pediatrics\/article\/129\/3\/480\/31727\/Enrollment-of-Extremely-Low-Birth-Weight-Infants"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,3,1]]},"references-count":8,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2012,3,1]]},"published-print":{"date-parts":[[2012,3,1]]}},"URL":"https:\/\/doi.org\/10.1542\/peds.2011-2121","relation":{},"ISSN":["0031-4005","1098-4275"],"issn-type":[{"value":"0031-4005","type":"print"},{"value":"1098-4275","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,3,1]]}}}