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

Abstract

The ideal choice of initial fraction of inspired oxygen (FiO₂) to stabilize preterm neonates in the delivery room (DR) is not well-established. To compare the effects of different initial FiO₂ in neonates < 34 weeks' gestation requiring respiratory support for DR stabilization. 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) FiO₂, followed by titration to peripheral oxygen saturation (SpO₂) targets. The primary outcome was the proportion of neonates achieving a target SpO₂ of ≥ 80 % at 5 min of life. Secondary outcomes were minute-specific SpO₂, heart rate (HR) and FiO₂ 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. The proportion of neonates achieving SpO₂ ≥ 80 % at 5 min was 58 (73.3 %) with 60 % compared to 38 (50.7 %) with 30 % FiO₂ [relative risk (95 % confidence interval), 1.53 (1.18, 1.97); p < 0.001]. Though minute-specific SpO₂ and FiO₂ 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. A significantly higher number of preterm neonates < 34 weeks' gestation requiring DR stabilization achieved a 5-minute SpO₂ of ≥ 80 % with higher minute-specific SpO₂ trends when stabilized with an initial FiO₂ of 60 % compared to 30 %.