Optimum oxygen concentration for initiation of delivery room stabilization in preterm neonates: A Randomized Controlled Trial

Rationale The ideal choice of initial fraction of inspired oxygen (FiO(2)) to stabilize preterm neonates in the delivery room (DR) is not well-established. Objective To compare the effects of different initial FiO(2) in neonates < 34 weeks' gestation requiring respiratory support for DR stabilization. Methods In this open-labeled, assessor-blinded, parallel-group randomized controlled trial, 150 neonates were allocated to initiate DR-stabilization with 60 % (n = 75) versus 30 % (n = 75) FiO(2), followed by titration to peripheral oxygen saturation (SpO(2)) targets. The primary outcome was the proportion of neonates achieving a target SpO(2) of >= 80 % at 5 min of life. Secondary outcomes were minute-specific SpO(2), heart rate (HR) and FiO(2) trends till 10 min, regional cerebral oxygenation (CrSO2) at one hour, need for surfactant and caffeine, respiratory support duration, in-hospital adverse events, mortality, and duration of hospitalization. Stata 15 was used for an intention-to-treat analysis. Results The proportion of neonates achieving SpO(2) >= 80 % at 5 min was 58 (73.3 %) with 60 % compared to 38 (50.7 %) with 30 % FiO(2) [relative risk (95 % confidence interval), 1.53 (1.18, 1.97); p < 0.001]. Though minute-specific SpO(2) and FiO(2) were significantly higher in the 60 % group, HR trends were comparable. No difference was observed in CrSO2, need and duration of respiratory support, surfactant, and caffeine, incidences of adverse events including mortality, and the duration of hospital stay. Conclusion A significantly higher number of preterm neonates < 34 weeks' gestation requiring DR stabilization achieved a 5-minute SpO(2) of >= 80 % with higher minute-specific SpO(2) trends when stabilized with an initial FiO(2) of 60 % compared to 30 %.