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Updated: Sep 27, 2025
The Perinatal Asphyxiated Lamb Model: A Model for Newborn Resuscitation
Published on: August 15, 2018
Delivery Room Respiratory Stabilization of Preterm Neonates: A Randomized, Controlled Trial
Rajat Grover1, Poonam Singh1, Shantanu Shubham1
1Department of Neonatology, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, 249203, India.
Objective:
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.
Methods:
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 24 h. 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 72 h, need for surfactant, intubation, duration of respiratory support, and incidences of adverse events including mortality. Intention-to-treat analysis was done in Stata software.
Results:
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.
Conclusions:
HHHFNC showed similar efficacy and safety as NCPAP irrespective of gestational age, though its noninferiority to NCPAP remained inconclusive.
Trial Registration:
Clinical Trial Registry of India, Registration no: CTRI/2019/10/021633, https://ctri.icmr.org.in/.
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