{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T11:55:55Z","timestamp":1786449355736,"version":"build-2736575974"},"reference-count":13,"publisher":"Georg Thieme Verlag KG","issue":"08","funder":[{"name":"National Institutes of Health and Child Development","award":["1R01HD088646-01A1"],"award-info":[{"award-number":["1R01HD088646-01A1"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Am J Perinatol"],"published-print":{"date-parts":[[2022,6]]},"abstract":"<jats:p>\n            Objective\u2003This study aimed to determine whether outcomes differed between infants enrolled in the PREMOD2 trial and those otherwise eligible but not enrolled, and whether the use of waiver effected these differences.<\/jats:p><jats:p>\n            Study Design\u2003The multicenter PREMOD2 (PREmature infants receiving Milking Or Delayed cord clamping) trial was approved for waiver of antenatal consent by six of the nine sites institutional review boards, while three sites exclusively used antenatal consent. Every randomized subject delivered at a site with a waiver of consent was approached for postnatal consent to allow for data collection. Four of those six sites IRBs required the study team to attempt antenatal consent when possible. Three sites exclusively used antenatal consent.<\/jats:p><jats:p>\n            Results\u2003Enrolled subjects had higher Apgar scores, less use of positive pressure ventilation, a lower rate of bronchopulmonary dysplasia, and a less frequent occurrence of the combined outcome of severe intraventricular hemorrhage or death. A significantly greater number of infants were enrolled at sites with an option of waiver of consent (66 vs. 26%, risk ratio\u2009=\u20092.54, p\u2009&lt;\u20090.001). At sites with an option of either approaching families before delivery or after delivery with a waiver of antenatal consent, those approached prior to delivery refused consent 40% (range 15\u201374% across six sites) of the time.<\/jats:p><jats:p>\n            Conclusion\u2003PREMOD2 trial demonstrated analytical validity limitations because of the variable mix of antenatal consent and waiver of consent. A waiver of antenatal consent for minimal risk interventional trials conducted during the intrapartum period will be more successful in enrolling a representative sample of low and high-risk infants if investigators are able to enroll all eligible subjects.<\/jats:p><jats:p>\n            Clinical Trial Registration\u2003ClinicalTrials.gov identifier: NCT03019367.<\/jats:p><jats:p>\n            Key Points\n          <\/jats:p>","DOI":"10.1055\/s-0040-1719184","type":"journal-article","created":{"date-parts":[[2020,11,3]],"date-time":"2020-11-03T23:42:15Z","timestamp":1604446935000},"page":"904-908","source":"Crossref","is-referenced-by-count":9,"title":["Perinatal Outcomes of Subjects Enrolled in a Multicenter Trial with a Waiver of Antenatal Consent"],"prefix":"10.1055","volume":"39","author":[{"given":"Anup C.","family":"Katheria","sequence":"additional","affiliation":[{"name":"Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phillip","family":"Allman","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, The UAB School of Public Health, Birmingham, Alabama"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeff M.","family":"Szychowski","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, The UAB School of Public Health, Birmingham, Alabama"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jochen","family":"Essers","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Ulm, Ulm, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Waldemar A.","family":"Carlo","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Alabama, Birmingham, Alabama"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georg M.","family":"Schm\u00f6lzer","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eugene","family":"Dempsey","sequence":"additional","affiliation":[{"name":"Department of Paediatrics and INFANT Centre, University College Cork, Cork, Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toby","family":"Yanowitz","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Kaempf","sequence":"additional","affiliation":[{"name":"Women and Children's Services, Providence St. Vincent Medical Center, Portland, Oregon"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Farha","family":"Vora","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Loma Linda University, Loma Linda, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shazia","family":"Bhat","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, ChristianaCare Health System, Newark, Delaware"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathy","family":"Arnell","sequence":"additional","affiliation":[{"name":"Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wade","family":"Rich","sequence":"additional","affiliation":[{"name":"Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Varner","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, 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