Comparison Of Intratracheal Administration Of Surfactant With Or Without Budesonide To Prevent Bronchopulmonary Dysplasia – A Parallel Randomized Pilot Study

Abstract Purpose : Despite improvements in preterm neonatal care, the incidence of bronchopulmonary dysplasia (BPD) has not decreased. Systemic glucocorticoids minimize BPD, but they may interfere with brain development. The impact of intratracheal budesonide along with surfactant on the incidence of BPD in extremely preterm infants is unknown. Methods: This two arm parallel pilot trial over a period of 18 months recruited extreme preterm (<28 weeks) and extreme low birth weight (ELBW) neonates who were diagnosed with severe RDS (respiratory distress syndrome). Neonates were randomly allocated to one of two groups (54 intervention and 55 control). Intratracheal surfactant and budesonide were administered to the intervention group, while surfactant alone was administered to the control group. Results: The study population had a mean gestational age of 26.1 ± 0.2 weeks and birth weight of 770.5 ± 31.5 grams. Death ( RR 0.65 [0.30-1.38]; p = 0.267) and combined BPD or death (RR 0.88 [0.73-1.06]; p = 0.211) exhibited a non-significant decreasing trend; however, a significant reduction in the combined outcome of severe BPD or death (RR 0.57(0.33-0.97);p=0.040) was observed in the intervention group. Conclusion: Intratracheal budesonide with surfactant administration is feasible . This may minimize severe BPD or death in extremely preterm infants with severe RDS without any harm.