Background: Bronchopulmonary dysplasia (BPD) remains a major problem in preterm infants that occurs in up to 50% of infants who are born at less than 28 weeks gestational age. The inflammation plays an important role in the pathogenesis of BPD. This study was conducted to evaluate the efficacy of intratracheal budesonide administration in combination with surfactant in the prevention of BPD in preterm infants. Materials and methods: In a randomized clinical trial, 128 preterm infants at less than 30 weeks gestational age and birth weight less than 1500 g were studied. All of them had respiratory distress syndrome (RDS) and needed surfactant replacement therapy. They were randomly allocated in two groups, surfactant group (n=64) and surfactant+budesonide group (n=64). Neonates in surfactant group received intratracheal Curosurf 200mg/kg/dose. Patients in surfactant+ budesonide group treated with an intratracheal instillation of a mixed suspension of budesonide 0.25 mg / kg and Curosurf 200mg/kg/dose. Neonates were followed till discharge for the primary outcome which was BPD and secondary outcome including sepsis, patent ductus arteriosus (PDA), retinopathy of prematurity (ROP) and necrotizing enterocolitis (NEC). Results: The mean gestational age and birth weight of studied neonates were 28.3±1.6 weeks and 1072±180 grams, respectively. The demographic characteristics and RDS score were similar in the two groups. BPD occurred in 24 (37.5%) neonates in surfactant + budesonide group and 38 (59.4%) neonates in surfactant group, p=0.04. Hospital stay was 29.7±19.2 (median 30) days in surfactant group and 23.3±18.1 (median 20) days in surfactant +budesonide group, p=0.05. The rate of sepsis, PDA, ROP and NEC were not significantly different in two groups. Conclusion: Based on our findings, the use of budesonide in addition to surfactant for rescue therapy of RDS in preterm infants decreases the incidence of BPD and duration of respiratory support significantly. Large adequately powered clinical trials with long term safety assessment are needed to confirm our findings before its routine use can be recommended.

Background: Bronchopulmonary dysplasia (BPD) remains a major problem in preterm infants that occurs in up to 50% of infants who are born at less than 28 weeks gestational age. The inflammation plays an important role in the pathogenesis of BPD. This study was conducted to evaluate the efficacy of...