Study Comparing Nasal High Flow Therapy and Nasal Continuous Positive Airway Pressure for Breathing Support in Stable Preterm Infants up to 31 Weeks

What this Trial Is About

Researchers are investigating whether nasal high flow therapy NHF is as effective as the traditional nasal continuous positive airway pressure NCPAP for helping stable premature babies breathe. This study focuses on preterm infants with respiratory distress syndrome who require prolonged breathing support. The goal is to compare how well two NHF flow rates perform in maintaining cardiorespiratory stability, while also considering comfort and potential benefits for the infants. The trial randomly assigns preterm infants to one of three groups NHF at 8Lmin, NHF at 6Lmin, or NCPAP at 6 cm H2O. All infants are stable on NCPAP before randomization. The study takes place at two neonatal centers and monitors infants during the intervention and follow-up periods, which may last from 7 days up to about 10 weeks. Researchers assess breathing support effectiveness and comfort using various clinical measures and scoring systems. During the trial, babies are closely monitored for treatment failure within 24 hours and other vital signs such as apnea episodes, heart rate, oxygen levels, and respiratory rate. Comfort assessments, cerebral oxygen saturation, lung function, and growth measurements are also collected. Parental observations of comfort and bonding are evaluated. The study tracks outcomes until discharge, estimated around 38 to 40 weeks postmenstrual age, ensuring thorough safety and effectiveness monitoring throughout the participation period.

Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants