Sustained inflation and chest compression versus 3:1 chest compression to ventilation ratio during cardiopulmonary resuscitation of asphyxiated newborns (SURV1VE): A cluster randomised controlled trial

Objective In newborn infants requiring chest compression (CC) in the delivery room (DR) does continuous CC superimposed by a sustained inflation (CC+SI) compared with a 3:1 compression:ventilation (3:1 C:V) ratio decreases time to return of spontaneous circulation (ROSC).Design International, multicenter, prospective, cluster cross-over randomised trial.Setting DR in four hospitals in Canada and Austria,Participants Newborn infants >28 weeks' gestation who required CC.Interventions Hospitals were randomised to CC+SI or 3:1 C:V then crossed over to the other intervention.Main outcome measure The primary outcome was time to ROSC, defined as the duration of CC until an increase in heart rate >60/min determined by auscultation of the heart, which was maintained for 60 s. Sample size of 218 infants (109/group) was sufficient to detect a clinically important 33% reduction (282 vs 420 s of CC) in time to ROSC. Analysis was intention-to-treat.Results Patient recruitment occurred between 19 October 2017 and 22 September 2022 and randomised 27 infants (CC+SI (n=12), 3:1 C:V (n=15), two (one per group) declined consent). All 11 infants in the CC+SI group and 12/14 infants in the 3:1 C:V group achieved ROSC in the DR. The median (IQR) time to ROSC was 90 (60-270) s and 615 (174-780) s (p=0.0502 (log rank), p=0.16 (cox proportional hazards regression)) with CC+SI and 3:1 C:V, respectively. Mortality was 2/11 (18.2%) with CC+SI versus 8/14 (57.1%) with 3:1 C:V (p=0.10 (Fisher's exact test), OR (95% CI) 0.17; (0.03 to 1.07)). The trial was stopped due to issues with ethics approval and securing trial insurance as well as funding reasons.Conclusion The time to ROSC and mortality was not statistical different between CC+SI and 3:1 C:V.Trial registration NCT02858583.