Heated humidified high flow nasal cannula with individualized flow titration (8–12 l/min) versus nasal cpap as primary respiratory support in preterm neonates of 28–36 weeks’ gestation with respiratory distress syndrome: a pilot randomised controlled trial

This is parallel group pilot randomised controlled trial (RCT) which will be conducted from 15th February 2025 until 15th March 2027, in a level 3 NICU centre in Hyderabad, India.  Neonates born between 28 0/7 – 36 6/7 weeks’ gestation and meeting the inclusion criteria will be eligible for inclusion after obtaining informed consent from the parent or the caretaker. The protocol has taken the respective Institutional Ethical Committee approval. Enrolled neonates will be randomized into two groups namely, Heated Humidified High Flow Nasal Cannula (HHHFNC) at 8–12 L/min versus nasal CPAP (NCPAP). Baseline characteristics will be recorded after enrolment using a pre-determined structured proforma. The primary outcome will be a composite of receipt of surfactant therapy or treatment failure or requirement of invasive mechanical ventilation (IMV) within 72 hours of life.