Comparison of Intratracheal Administration of Surfactant With or Without Budesonide to Prevent Bronchopulmonary Dysplasia: A Parallel Randomized Pilot Study

Abstract

Background: While advancements in premature neonatal care have led to a reduction in mortality and respiratory distress syndrome (RDS), the incidence of bronchopulmonary dysplasia (BPD) has remained unchanged over the past few decades. Few small, randomized trials have shown intratracheal budesonide in a surfactant vehicle as a promising treatment to reduce the incidence of BPD. Objective: To investigate whether intratracheal administration of surfactant combined with budesonide results in decreased incidence of BPD, death, and other morbidities in preterm infants who were born <28 weeks and <1 kg. Study Design: Prospective two-arm pilot randomized controlled trial with concurrent parallel design. Participants and Methods: This study included extreme preterm (<28 weeks) and extreme low birth weight newborns with severe RDS. Neonates were randomly allocated to one of two groups (60 intervention and 61 control). The intervention group received intratracheal surfactant and budesonide, while the control group received only surfactant. Results: The study population had a mean gestational age of 26.1 ± 0.2 weeks and birth weight of 766.1 ± 29.1 g. Death (RR 0.61 (0.1-3.62); P = 1.00) and combined BPD or death (RR 0.86 (0.55-1.33); P = .88) exhibited a nonsignificant decreasing trend. However, any intraventricular hemorrhage (IVH), severe brain injury (≥III IVH or periventricular leukomalacia), oxygen requirement at 24 h of life, and ventilation days were significantly lower in the intervention group. Conclusion: Intratracheal budesonide and surfactant did not reduce BPD or death. As a pilot study, this study speaks about the trend and was not powered to comment on the significance of the result. Oxygen, ventilation needs, and preterm brain injury are considerably lesser with when budesonide is combined with surfactant among extreme preterm newborns.