Maureen C Reilly1, Sunita Vohra2, Valeria E Rac3, Michael Dunn4, Karla Ferrelli5, Alex Kiss6, Michael Vincer7, John Wimmer8, Denise Zayack1, Roger F Soll9. 1. Women and Babies Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. 2. Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada; Women's and Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada. Electronic address: svohra@ualberta.ca. 3. Women and Babies Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; The Toronto Health Economics and Technology Assessment (THETA) Collaborative, Institute of Health Policy, Management and Evaluation (IHPME), Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada. 4. Women and Babies Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Division of Neonatology, Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada. 5. Vermont Oxford Network, Burlington, VT. 6. Department of Research Design and Biostatistics, Sunnybrook Research Institute, Toronto, Ontario, Canada. 7. Neonatal Perinatal Medicine, Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada. 8. Neonatology, Women's Hospital, Greensboro, NC. 9. Vermont Oxford Network, Burlington, VT; Department of Pediatrics, University of Vermont, Burlington, VT.
Abstract
OBJECTIVE: To determine whether the application of occlusive wrap applied immediately after birth will reduce mortality in very preterm infants. STUDY DESIGN: This was a prospective randomized controlled trial of infants born 24 0/7 to 27 6/7 weeks' gestation who were assigned randomly to occlusive wrap or no wrap. The primary outcome was all cause mortality at discharge or 6 months' corrected age. Secondary outcomes included temperature, Apgar scores, pH, base deficit, blood pressure and glucose, respiratory distress syndrome, bronchopulmonary dysplasia, seizures, patent ductus arteriosus, necrotizing enterocolitis, gastrointestinal perforation, intraventricular hemorrhage, cystic periventricular leukomalacia, pulmonary hemorrhage, retinopathy of prematurity, sepsis, hearing screen, and pneumothorax. RESULTS:Eight hundred one infants were enrolled. There was no difference in baseline population characteristics. There were no significant differences in mortality (OR 1.0, 95% CI 0.7-1.5). Wrap infants had statistically significant greater baseline temperatures (36.3°C wrap vs 35.7°C no wrap, P < .0001) and poststabilization temperatures (36.6°C vs 36.2°C, P < .001) than nonwrap infants. For the secondary outcomes, there was a significant decrease in pulmonary hemorrhage (OR 0.6, 95% CI 0.3-0.9) in the wrap group and a significant lower mean one minute Apgar score (P = .007) in the wrap group. The study was stopped early because continued enrollment would not result in the attainment of a significant difference in the primary outcome. CONCLUSION: Application of occlusive wrap to very preterm infants immediately after birth results in greater mean body temperature but does not reduce mortality.
RCT Entities:
OBJECTIVE: To determine whether the application of occlusive wrap applied immediately after birth will reduce mortality in very preterm infants. STUDY DESIGN: This was a prospective randomized controlled trial of infants born 24 0/7 to 27 6/7 weeks' gestation who were assigned randomly to occlusive wrap or no wrap. The primary outcome was all cause mortality at discharge or 6 months' corrected age. Secondary outcomes included temperature, Apgar scores, pH, base deficit, blood pressure and glucose, respiratory distress syndrome, bronchopulmonary dysplasia, seizures, patent ductus arteriosus, necrotizing enterocolitis, gastrointestinal perforation, intraventricular hemorrhage, cystic periventricular leukomalacia, pulmonary hemorrhage, retinopathy of prematurity, sepsis, hearing screen, and pneumothorax. RESULTS: Eight hundred one infants were enrolled. There was no difference in baseline population characteristics. There were no significant differences in mortality (OR 1.0, 95% CI 0.7-1.5). Wrap infants had statistically significant greater baseline temperatures (36.3°C wrap vs 35.7°C no wrap, P < .0001) and poststabilization temperatures (36.6°C vs 36.2°C, P < .001) than nonwrap infants. For the secondary outcomes, there was a significant decrease in pulmonary hemorrhage (OR 0.6, 95% CI 0.3-0.9) in the wrap group and a significant lower mean one minute Apgar score (P = .007) in the wrap group. The study was stopped early because continued enrollment would not result in the attainment of a significant difference in the primary outcome. CONCLUSION: Application of occlusive wrap to very preterm infants immediately after birth results in greater mean body temperature but does not reduce mortality.
Authors: W Lapcharoensap; M V Bennett; R J Powers; N N Finer; L P Halamek; J B Gould; P J Sharek; H C Lee Journal: J Perinatol Date: 2016-12-22 Impact factor: 2.521
Authors: Leeann R Pavlek; Brian K Rivera; Charles V Smith; Joanie Randle; Cory Hanlon; Kristi Small; Edward F Bell; Matthew A Rysavy; Sara Conroy; Carl H Backes Journal: J Pediatr Date: 2021-04-21 Impact factor: 6.314