Parallel Exploratory RCT of Polyethylene Wrap for Heat Loss Prevention in Infants Born at Less than 24 Weeks’ Gestation
Autor: | John E Wimmer, Sunita Vohra, Roger F. Soll, Michael Vincer, Alex Kiss, Valeria E. Rac, Denise Zayack, Maureen Reilly, Michael Dunn, Karla R. Ferrelli |
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Rok vydání: | 2019 |
Předmět: |
Male
Canada Pediatrics medicine.medical_specialty Standard of care Population Gestational Age Hypothermia Infant Premature Diseases macromolecular substances Body Temperature law.invention Randomized controlled trial law medicine Humans Treatment effect education education.field_of_study business.industry Delivery Rooms Significant difference Infant Newborn technology industry and agriculture Heat losses Small sample equipment and supplies Bandages Polyethylene Infant Extremely Premature biological sciences Pediatrics Perinatology and Child Health Gestation Female business Developmental Biology |
Zdroj: | Neonatology. 116:37-41 |
ISSN: | 1661-7819 1661-7800 |
Popis: | Background: The treatment effect of occlusive wrap applied immediately after delivery in infants born 24–28 weeks’ gestation has been studied, but the effect is not known in infants born at less than 240/7 weeks’ gestation. Objectives: To determine if the use of occlusive wrap applied immediately after birth in infants born at less than 240/7 weeks’ gestation results in any differences in outcomes when compared to non-wrapped infants. Methods: Parallel exploratory randomized controlled trial with a convenience sample of 28 inborn infants born at less than 240/7 weeks’ gestation enrolled during the duration of the HeLP trial. Infants were randomized to either the wrap or standard of care (no wrap) group. Results: Twenty-eight infants (wrap n = 14; no wrap n = 14) were randomized and data on all infants was available for intention-to-treat analysis. There were no differences in baseline population characteristics. There was no statistically significant difference in mortality (n = 8/14 wrap, 8/14 no wrap). There was no statistically significant difference in baseline temperature (35.9°C, SD = 1.12, wrap vs. 35.1°C, SD = 1.16, no wrap, p = 0.16) or post-stabilization temperature (36.4°C, SD = 0.84, wrap vs. 36.1°C, SD = 1.2, no wrap, p = 0.56). There was a trend towards increased baseline temperature in the wrap group. Conclusion: Application of occlusive wrap to infants born at less than 240/7 weeks’ gestation immediately after birth did not reduce mortality or effect baseline or post-stabilization temperature in this small exploratory study. This small sample provides the first estimate of treatment effect for this high-risk population. |
Databáze: | OpenAIRE |
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