Abstract
BACKGROUND: Bronchopulmonary dysplasia (BPD) remains a major problem in preterm infants that occurs in up to 50% of preterm infants. The inflammation plays an important role in its pathogenesis. This study was conducted to evaluate the efficacy intratracheal budesonide administration in combination with surfactant in the prevention of BPD in preterm infants. MATERIALS AND METHODS: In a randomized controlled clinical trial, 128 preterm infants with gestation age <30 weeks and birth weight <1250 g who had respiratory distress syndrome (RDS) and need surfactant replacement therapy were studied. They randomly allocated into two groups, surfactant group (n = 64) and surfactant + budesonide group (n = 64). Patients were followed till discharge for the primary outcome which was BPD. RESULTS: The mean gestation age and birth weight of studied neonates were 28.3 ± 1.6 weeks and 1072 ± 180 g, respectively. BPD was occurred in 20 (31.3%) neonates in surfactant + budesonide group and 38 (59.4%) patients in surfactant group, P = 0.02. Respiratory support was needed in two groups similarly, but the mean duration of respiratory support was significantly longer in surfactant group in comparison with surfactant + budesonide group (mechanical ventilation 2.8 ± 0.6 vs. 0.8 ± 0.1 days, P = 0.006, nasal continuous positive airway pressure 5.2 ± 3.0 vs. 4.0 ± 3.5 days, P = 0.04 and high flow nasal cannula 7.7 ± 0.9 vs. 4.1 ± 0.5 days, P = 0.001). CONCLUSION: Based on our findings, the use of budesonide in addition to surfactant for rescue therapy of RDS significantly decreases the incidence of BPD and duration of respiratory support. Future studies are recommended with a large number of patients before routine administration of surfactant and budesonide combination.