Ontology highlight
ABSTRACT: Background
Optimal starting oxygen concentration for delivery room resuscitation of extremely preterm infants (<29 weeks) remains unknown, with recommendations of 21-30% based on uncertain evidence. Individual patient randomized trials designed to answer this question have been hampered by poor enrolment.Hypothesis
It is feasible to compare 30% vs. 60% starting oxygen for delivery room resuscitation of extremely preterm infants using a change in local hospital policy and deferred consent approach.Study design
Prospective, single-center, feasibility study, with each starting oxygen concentration used for two months for all eligible infants.Population
Infants born at 23 + 0-28 + 6 weeks' gestation who received delivery room resuscitation. Study interventions: Initial oxygen at 30% or 60%, increasing by 10-20% every minute for heart rate < 100 bpm, or increase to 100% for chest compressions.Primary outcome
Feasibility, defined by (i) achieving difference in cumulative supplied oxygen concentration between groups, and (ii) post-intervention rate consent >50%.Results
Thirty-four infants were born during a 4-month period; consent was obtained in 63%. Thirty (n = 12, 30% group; n = 18, 60% group) were analyzed, including limited data from eight who died or were transferred before parents could be approached. Median cumulative oxygen concentrations were significantly different between the two groups in the first 5 min.Conclusion
Randomized control trial of 30% or 60% oxygen at the initiation of resuscitation of extremely preterm neonates with deferred consent is feasible.Trial registration
Clinicaltrials.gov NCT03706586.
SUBMITTER: Law BHY
PROVIDER: S-EPMC8625238 | biostudies-literature |
REPOSITORIES: biostudies-literature