Perinatal Outcomes of Subjects Enrolled in a Multicenter Trial with a Waiver of Antenatal Consent.
Objective This 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. Study Design The multicenter PREMOD2 (PREmature infants receiving Milking Or Dela...
| Publicado en: | American Journal of Perinatology Vol. 39; no. 8; pp. 904 - 909 |
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| Autores principales: | , , , , , , , , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Thieme Medical Publishing Inc.
2022
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=157896093&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 157896093 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 07351631 GQK jtl: American Journal of Perinatology issn: 07351631 maglogo: N pubinfo: dt: 2022 vid: 39 iid: 8 pid: 2811 pub: Thieme Medical Publishing Inc. place: New York, New York artinfo: ui: 157896093 157896093 157896093 10.1055/s-0040-1719184 157896093 ppf: 904 ppct: 5 formats: tig: atl: Perinatal Outcomes of Subjects Enrolled in a Multicenter Trial with a Waiver of Antenatal Consent. aug: au: Katheria, Anup C. Allman, Phillip Szychowski, Jeff M. Essers, Jochen Carlo, Waldemar A. Schmölzer, Georg M. Dempsey, Eugene Yanowitz, Toby Kaempf, Joseph Vora, Farha Bhat, Shazia Arnell, Kathy Rich, Wade Varner, Michael affil: Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, 3003 Health Center Drive, San Diego, CA 92123 sug: subj: Perinatal Care Pregnancy Outcomes Consent (Research) Umbilical Cord Clamping Research Subjects Multicenter Studies Human Milk Infant, Premature Random Sample Apgar Score Positive Pressure Ventilation Bronchopulmonary Dysplasia Cerebral Hemorrhage Death Descriptive Statistics Family Pregnancy Female Female ab: Objective This 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. Study Design The 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. Results Enrolled 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 = 2.54, p < 0.001). 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 15–74% across six sites) of the time. Conclusion PREMOD2 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. Clinical Trial Registration ClinicalTrials.gov identifier: NCT03019367. Key Points Waiver of consent is when informed consent cannot be obtained prior to delivery. Cord milking is a procedure in which blood is pushed (stripped) two to four times towards the newborn. Delayed clamping means the umbilical cord is not clamped immediately after birth. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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