{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T05:09:09Z","timestamp":1777612149802,"version":"3.51.4"},"reference-count":26,"publisher":"American Academy of Pediatrics (AAP)","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2018,1,1]]},"abstract":"<jats:sec>\n                  <jats:title>BACKGROUND AND OBJECTIVES:<\/jats:title>\n                  <jats:p>The requirement for prospective consent in clinical trials in acute settings may result in samples unrepresentative of the study population, potentially altering study findings. However, using retrospective consent may raise ethical issues. We assessed whether using retrospective consent affected recruitment, participant characteristics, and outcomes within a randomized controlled trial.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>METHODS:<\/jats:title>\n                  <jats:p>We conducted a secondary analysis of a randomized trial, which compared nasal high flow (nHF) with nasal continuous positive airway pressure (CPAP) for primary respiratory support in preterm infants. In Era 1, all infants were consented prospectively; in Era 2, retrospective consent was available. We assessed inclusion rates of eligible infants, demographic data, and primary trial outcome (treatment failure within 72 hours).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS:<\/jats:title>\n                  <jats:p>In Era 1, recruitment of eligible infants was lower than in Era 2: 111 of 220 (50%) versus 171 of 209 (82%), P &amp;lt; .001; intrapartum antibiotic administration was lower: 23 of 111 (21%) versus 84 of 165 (51%), P &amp;lt; .001; full courses of antenatal steroids were higher: 86 of 111 (78%) versus 103 of 170 (61%), P = .004; and more infants received pre-randomization CPAP: 77 of 111 (69%) versus 48 of 171 (28%), P &amp;lt; .001. In Era 1, nHF failure (15 of 56, 27%) and CPAP failure (14 of 55, 26%) rates were similar, P = .9. In Era 2, failure rates differed: 24 of 85 (28%) nHF infants versus 13 of 86 (15%) CPAP infants, P = .04. The \u03c72 interaction test was nonsignificant (P = .20).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS:<\/jats:title>\n                  <jats:p>The use of retrospective consent resulted in greater recruitment and differences in risk factors between eras. Using retrospective consent altered the study sample, which may be more representative of the whole population. This may improve scientific validity but requires further ethical evaluation.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1542\/peds.2017-2092","type":"journal-article","created":{"date-parts":[[2017,12,29]],"date-time":"2017-12-29T08:30:17Z","timestamp":1514536217000},"source":"Crossref","is-referenced-by-count":30,"title":["Retrospective Consent in a Neonatal Randomized Controlled Trial"],"prefix":"10.1542","volume":"141","author":[{"given":"Nils T.","family":"Songstad","sequence":"first","affiliation":[{"name":"Newborn Research Centre and"},{"name":"Department of Pediatrics and Adolescent Medicine, University Hospital of North Norway, Troms\u00f8, Norway;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Calum T.","family":"Roberts","sequence":"additional","affiliation":[{"name":"Newborn Research Centre and"},{"name":"Neonatal Services, The Royal Women\u2019s Hospital, Melbourne, Australia;"},{"name":"Department of Obstetrics and Gynaecology, The University of Melbourne, Melbourne, Australia; and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brett J.","family":"Manley","sequence":"additional","affiliation":[{"name":"Newborn Research Centre and"},{"name":"Neonatal Services, The Royal Women\u2019s Hospital, Melbourne, Australia;"},{"name":"Department of Obstetrics and Gynaecology, The University of Melbourne, Melbourne, Australia; and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Louise S.","family":"Owen","sequence":"additional","affiliation":[{"name":"Newborn Research Centre and"},{"name":"Neonatal Services, The Royal Women\u2019s Hospital, Melbourne, Australia;"},{"name":"Department of Obstetrics and Gynaecology, The University of Melbourne, Melbourne, Australia; and"},{"name":"Murdoch Children\u2019s Research Institute, Melbourne, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter G.","family":"Davis","sequence":"additional","affiliation":[{"name":"Newborn Research Centre and"},{"name":"Neonatal Services, The Royal Women\u2019s Hospital, Melbourne, Australia;"},{"name":"Department of Obstetrics and Gynaecology, The University of Melbourne, Melbourne, Australia; and"},{"name":"Murdoch Children\u2019s Research Institute, Melbourne, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"on behalf of the HIPSTER trial investigators","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"417","published-online":{"date-parts":[[2018,1,1]]},"reference":[{"issue":"8","key":"2021120916295346400_B1","doi-asserted-by":"crossref","first-page":"822","DOI":"10.1111\/acem.12180","article-title":"Waiver of informed consent in pediatric resuscitation research: a systematic review.","volume":"20","author":"Eltorki","year":"2013","journal-title":"Acad Emerg Med"},{"issue":"5","key":"2021120916295346400_B2","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2015-0546A","article-title":"Delivery room research: when does poor quality evidence become an ethical issue?","volume":"135","author":"Foglia","year":"2015","journal-title":"Pediatrics"},{"issue":"20","key":"2021120916295346400_B3","doi-asserted-by":"crossref","first-page":"2191","DOI":"10.1001\/jama.2013.281053","article-title":"World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.","volume":"310","author":"World Medical Association","year":"2013","journal-title":"JAMA"},{"issue":"1","key":"2021120916295346400_B4","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":"3","key":"2021120916295346400_B5","doi-asserted-by":"crossref","first-page":"480","DOI":"10.1542\/peds.2011-2121","article-title":"Enrollment of extremely low birth weight infants in a clinical research study may not be representative.","volume":"129","author":"Rich","year":"2012","journal-title":"Pediatrics"},{"issue":"21","key":"2021120916295346400_B6","first-page":"1970","article-title":"Early CPAP versus surfactant in extremely preterm infants [published correction appears in N Engl J Med. 2010;362(23):2235].","volume":"362","author":"Finer","year":"2010","journal-title":"N Engl J Med"},{"issue":"5","key":"2021120916295346400_B7","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2015-0512","article-title":"Deferred consent for randomized controlled trials in emergency care settings.","volume":"136","author":"Harron","year":"2015","journal-title":"Pediatrics"},{"issue":"12","key":"2021120916295346400_B8","doi-asserted-by":"crossref","first-page":"1142","DOI":"10.1056\/NEJMoa1603694","article-title":"Nasal high-flow therapy for primary respiratory support in preterm infants.","volume":"375","author":"Roberts","year":"2016","journal-title":"N Engl J Med"},{"key":"2021120916295346400_B9","volume-title":"National Statement on Ethical Conduct in Human Research 2007 (Updated May 2015)","author":"National Health and Medical Research Council","year":"2015"},{"issue":"6","key":"2021120916295346400_B10","doi-asserted-by":"crossref","first-page":"e008483","DOI":"10.1136\/bmjopen-2015-008483","article-title":"A multicentre, randomised controlled, non-inferiority trial, comparing high flow therapy with nasal continuous positive airway pressure as primary support for preterm infants with respiratory distress (the HIPSTER trial): study protocol.","volume":"5","author":"Roberts","year":"2015","journal-title":"BMJ Open"},{"issue":"9","key":"2021120916295346400_B11","doi-asserted-by":"crossref","first-page":"1024","DOI":"10.1136\/hrt.2007.120113","article-title":"Consent bias in research: how to avoid it.","volume":"93","author":"Junghans","year":"2007","journal-title":"Heart"},{"issue":"5","key":"2021120916295346400_B12","doi-asserted-by":"crossref","first-page":"1006","DOI":"10.1542\/peds.2014-0207","article-title":"When is waiver of consent appropriate in a neonatal clinical trial?","volume":"134","author":"Schreiner","year":"2014","journal-title":"Pediatrics"},{"issue":"1","key":"2021120916295346400_B13","doi-asserted-by":"crossref","first-page":"F90","DOI":"10.1136\/archdischild-2016-310934","article-title":"Obtaining informed consent for delivery room research: the investigators\u2019 perspective.","volume":"102","author":"Foglia","year":"2017","journal-title":"Arch Dis Child Fetal Neonatal Ed"},{"issue":"4","key":"2021120916295346400_B14","doi-asserted-by":"crossref","first-page":"F291","DOI":"10.1136\/archdischild-2016-310935","article-title":"Research ethics committee decision-making in relation to an efficient neonatal trial.","volume":"102","author":"Gale","year":"2017","journal-title":"Arch Dis Child Fetal Neonatal Ed"},{"key":"2021120916295346400_B15","unstructured":"US Department of Health and Human Services\n          . Guidance for institutional review boards, clinical investigators, and sponsors: exception from informed consent requirements for emergency research. 2013. Available at: https:\/\/www.fda.gov\/downloads\/regulatoryinformation\/guidances\/ucm249673.pdf. Accessed November 15, 2017"},{"issue":"2","key":"2021120916295346400_B16","doi-asserted-by":"crossref","first-page":"98","DOI":"10.1016\/S0146-0005(05)80030-8","article-title":"Use of unproven therapies in clinical practice and research: how can we better serve our patients and their families?","volume":"19","author":"Tyson","year":"1995","journal-title":"Semin Perinatol"},{"issue":"1","key":"2021120916295346400_B17","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2012-0802","article-title":"A randomized trial of stylets for intubating newborn infants.","volume":"131","author":"Kamlin","year":"2013","journal-title":"Pediatrics"},{"issue":"2","key":"2021120916295346400_B18","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2013-0361","article-title":"Mask versus nasal tube for stabilization of preterm infants at birth: a randomized controlled trial.","volume":"132","author":"Kamlin","year":"2013","journal-title":"Pediatrics"},{"issue":"1","key":"2021120916295346400_B19","doi-asserted-by":"crossref","first-page":"61","DOI":"10.1542\/peds.2015-0368","article-title":"Umbilical cord milking versus delayed cord clamping in preterm infants.","volume":"136","author":"Katheria","year":"2015","journal-title":"Pediatrics"},{"issue":"1","key":"2021120916295346400_B20","doi-asserted-by":"crossref","DOI":"10.1542\/peds.102.1.e1","article-title":"Resuscitation of asphyxiated newborn infants with room air or oxygen: an international controlled trial: the Resair 2 study.","volume":"102","author":"Saugstad","year":"1998","journal-title":"Pediatrics"},{"issue":"5","key":"2021120916295346400_B21","doi-asserted-by":"crossref","first-page":"912","DOI":"10.1542\/peds.2015-1028","article-title":"Videolaryngoscopy to teach neonatal intubation: a randomized trial.","volume":"136","author":"O\u2019Shea","year":"2015","journal-title":"Pediatrics"},{"key":"2021120916295346400_B22","doi-asserted-by":"crossref","first-page":"56","DOI":"10.3389\/fped.2017.00056","article-title":"Waiver of consent in a trial intervention occurring at birth-how do parents feel?","volume":"5","author":"Rich","year":"2017","journal-title":"Front Pediatr"},{"issue":"9","key":"2021120916295346400_B23","doi-asserted-by":"crossref","first-page":"e008522","DOI":"10.1136\/bmjopen-2015-008522","article-title":"How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study.","volume":"5","author":"Woolfall","year":"2015","journal-title":"BMJ Open"},{"issue":"18","key":"2021120916295346400_B24","doi-asserted-by":"crossref","first-page":"vii","DOI":"10.3310\/hta20180","article-title":"CATheter Infections in CHildren (CATCH): a randomised controlled trial and economic evaluation comparing impregnated and standard central venous catheters in children.","volume":"20","author":"Harron","year":"2016","journal-title":"Health Technol Assess"},{"issue":"12","key":"2021120916295346400_B25","doi-asserted-by":"crossref","first-page":"721","DOI":"10.1136\/jme.2004.011247","article-title":"Parental preferences for neonatal resuscitation research consent: a pilot study.","volume":"31","author":"Culbert","year":"2005","journal-title":"J Med Ethics"},{"issue":"4","key":"2021120916295346400_B26","doi-asserted-by":"crossref","first-page":"F321","DOI":"10.1136\/adc.2002.021931","article-title":"Neonatal research: the parental perspective.","volume":"89","author":"Stenson","year":"2004","journal-title":"Arch Dis Child Fetal Neonatal Ed"}],"container-title":["Pediatrics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/publications.aap.org\/pediatrics\/article-pdf\/doi\/10.1542\/peds.2017-2092\/1065418\/peds_20172092.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/publications.aap.org\/pediatrics\/article-pdf\/doi\/10.1542\/peds.2017-2092\/1065418\/peds_20172092.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,12,10]],"date-time":"2021-12-10T04:43:16Z","timestamp":1639111396000},"score":1,"resource":{"primary":{"URL":"https:\/\/publications.aap.org\/pediatrics\/article\/141\/1\/e20172092\/37686\/Retrospective-Consent-in-a-Neonatal-Randomized"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,1,1]]},"references-count":26,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2018,1,1]]},"published-print":{"date-parts":[[2018,1,1]]}},"URL":"https:\/\/doi.org\/10.1542\/peds.2017-2092","relation":{},"ISSN":["0031-4005","1098-4275"],"issn-type":[{"value":"0031-4005","type":"print"},{"value":"1098-4275","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,1,1]]},"article-number":"e20172092"}}