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Comparison of Respiratory Support After Delivery in Infants Born Before 28 Weeks' Gestational Age: The CORSAD Randomized Clinical Trial.
- Source :
-
JAMA pediatrics [JAMA Pediatr] 2021 Sep 01; Vol. 175 (9), pp. 911-918. - Publication Year :
- 2021
-
Abstract
- Importance: Establishing stable breathing is a key event for preterm infants after birth. Delivery of pressure-stable continuous positive airway pressure and avoiding face mask use could be of importance in the delivery room.<br />Objective: To determine whether using a new respiratory support system with low imposed work of breathing and short binasal prongs decreases delivery room intubations or death compared with a standard T-piece system with a face mask.<br />Design, Setting, and Participants: In this unblinded randomized clinical trial, mothers threatening preterm delivery before week 28 of gestation were screened. A total of 365 mothers were enrolled, and 250 infants were randomized before birth and 246 liveborn infants were treated. The trial was conducted in 7 neonatal intensive care units in 5 European countries from March 2016 to May 2020. The follow-up period was 72 hours after intervention.<br />Interventions: Infants were randomized to either the new respiratory support system with short binasal prongs (n = 124 infants) or the standard T-piece system with face mask (n = 122 infants). The intervention was providing continuous positive airway pressure for 10 to 30 minutes and positive pressure ventilation, if needed, with the randomized system.<br />Main Outcomes and Measures: The primary outcome was delivery room intubation or death within 30 minutes of birth. Secondary outcomes included respiratory and safety variables.<br />Results: Of 246 liveborn infants treated, the mean (SD) gestational age was 25.9 (1.3) weeks, and 127 (51.6%) were female. A total of 41 infants (33.1%) receiving the new respiratory support system were intubated or died in the delivery room compared with 55 infants (45.1%) receiving standard care. The adjusted odds ratio was statistically significant after adjusting for stratification variables (adjusted odds ratio, 0.53; 95% CI, 0.30-0.94; P = .03). No significant differences were seen in secondary outcomes or safety variables.<br />Conclusions and Relevance: In this study, using the new respiratory support system reduced delivery room intubation in extremely preterm infants. Stabilizing preterm infants with a system that has low imposed work of breathing and binasal prongs as interface is safe and feasible.<br />Trial Registration: ClinicalTrials.gov Identifier: NCT02563717.
- Subjects :
- Delivery, Obstetric adverse effects
Delivery, Obstetric instrumentation
Delivery, Obstetric methods
Female
Humans
Infant, Newborn
Intensive Care Units, Neonatal organization & administration
Intensive Care Units, Neonatal statistics & numerical data
Male
Odds Ratio
Outcome Assessment, Health Care methods
Respiratory Therapy methods
Respiratory Therapy statistics & numerical data
Sweden
Gestational Age
Outcome Assessment, Health Care statistics & numerical data
Respiratory Therapy standards
Subjects
Details
- Language :
- English
- ISSN :
- 2168-6211
- Volume :
- 175
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- JAMA pediatrics
- Publication Type :
- Academic Journal
- Accession number :
- 34125148
- Full Text :
- https://doi.org/10.1001/jamapediatrics.2021.1497