The efficacy of intra-tracheal budesonide with surfactant in treatment of respiratory distress syndrome and prevention of bronchopulmonary dysplasia

Background: Premature birth is an important issue in developed and developing countries. Surfactant replacement therapy of respiratory distress syndrome (RDS) causes a change in the normal pattern of the disease and increases the likelihood of survival of more premature newborns with chronic pulmonary damage. The purpose of this study was to investigate the effects of budesonide and surfactant on the treatment of respiratory distress syndrome and the prevention of bronchopulmonary dysplasia. Methods: In a randomized clinical trial, 128 preterm infants less than 1250 g or gestational age of 26-30 weeks that were admitted to Al-Zahra Hospital from 2017 to 2018 with RDS and needed surfactant replacement therapy were enrolled. They were randomly allocated into two groups. In one group (group Surfactant), the surfactant was administered intratracheally 2.5 cc/kg and in the second group (group Surfactant + Budesonide), budesonide was administered 0.25 mg/kg in addition to the intratracheal surfactant. The primary outcome was bronchopulmonary dysplasia and the secondary outcome was complications of prematurity. Results: In this study 128 neonates including 48 (60.9%) boys and 50 (39.1%) girls were studied. The mean gestational ages of studied neonates were 28.32±1.60 weeks. The mean duration of mechanical ventilation, continuous positive airway pressure (CPAP), high flow nasal cannulae (HFNC), and need for supplemental oxygen were significantly shorter in the group that received surfactant and budesonide combination. The required FiO2 at four hours after surfactant treatment was significantly lower in group Surfactant + Budesonide than the Surfactant group (p = 0.01). In the group Surfactant, 38 neonates (59.4%) and in group S+B, 24 cases (37.5%) developed bronchopulmonary dysplasia (BPD), (p = 0.04). The mortality rate was 15 neonates that 6 cases were in group S+B (p =0.29). Conclusion: In our study, using surfactant with budesonide combination in comparison with surfactant alone is associated with less respiratory support and BPD rate. Future studies with a larger number of patients before routine use of surfactant and budesonide combination is recommended.