Delivery Room Respiratory Stabilization of Preterm Neonates: A Randomized, Controlled Trial.

Abstract

To determine whether heated humidified high-flow nasal cannula (HHHFNC) is noninferior to NCPAP to provide DR respiratory support to preterm neonates of gestational age (GA) 28-36 wk. This randomized, controlled, noninferiority trial included 124 spontaneously breathing preterm neonates who developed respiratory distress soon after birth and/or had a FiO2 requirement > 0.3. Primary outcome measure was treatment failure within 24h. The absolute risk difference with 95% confidence interval (CI) were calculated with a noninferiority margin of 10%. Secondary outcome variables were temperature at admission, time to treatment failure, treatment failure at 72h, need for surfactant, intubation, duration of respiratory support, and incidences of adverse events including mortality. Intention-to-treat analysis was done in Stata software. Both the groups were similar in baseline characteristics. There was no statistically significant difference between the treatment failure rates with HHHFNC (13.1%, n = 61) and NCPAP (11.1%, n = 63) (risk difference 2.0%, 95% CI - 9.9% to 14.07%, p = 0.73). However, noninferiority of HHHFNC to NCPAP could not be conclusively proved as the 95% CI crossed both 0 and the noninferiority margin of 10%. There were no significant differences in secondary outcomes. HHHFNC showed similar efficacy and safety as NCPAP irrespective of gestational age, though its noninferiority to NCPAP remained inconclusive. Clinical Trial Registry of India, Registration no: CTRI/2019/10/021633, https://ctri.icmr.org.in/.