Comparison of the Effect of Surfactant Administration During Nasal Continuous Positive Airway Pressure with that of Nasal Continuous Positive Airway Pressure Alone on Complications of Respiratory Distress Syndrome: A Randomized Controlled Study

Abstract

Studies on early surfactant administration during nasal continuous positive airway pressure (NCPAP) [intubate-surfactant-extubate (INSURE)] have used continuous positive airway pressure and INSURE in the first hours after birth, but in many centers patients are transported from far away hospitals, reaching the center at a later time. The aim of this study was to compare the effect of INSURE with only NCPAP in the management of respiratory distress syndrome (RDS) in an outborn hospital. This study was a controlled randomized clinical trial on 60 neonates who were transported to the neonatal intensive care unit of Boo-Ali Sina Hospital. Neonates born at 27(0)/7 to 34(6)/7 weeks of gestation, aged ≤12 hours, and diagnosed with RDS were placed on NCPAP and then randomly assigned to INSURE or NCPAP alone. The primary outcome was the need for intubation and mechanical ventilation on the basis of the criteria defined by us, and the secondary outcomes were neonatal mortality and other complications of RDS. In 13 months, 60 eligible neonates were enrolled. Our participants in INSURE group received surfactant at the mean age of 5.1 hours. The relative risk of need for mechanical ventilation was 0.55 (95% confidence interval: 0.15-1.9, p=0.53), and the rate of mortality or other complications of RDS was statistically similar between the two groups. After the first few hours of life (mean age of 5.1 hours), the rate of mortality and chronic lung disease and the need for mechanical ventilation were not statistically different between patients receiving INSURE and those in receipt of NCPAP alone.