A randomized clinical trial has found that intratracheal budesonide, when mixed with surfactant, does not significantly improve survival free of bronchopulmonary dysplasia (BPD) in extremely preterm infants. The study, published in JAMA, challenges the potential benefits of early corticosteroid administration directly into the lungs of these vulnerable newborns.
The double-blind trial, conducted across 21 neonatal units in Australia, New Zealand, Canada, and Singapore, enrolled 1059 infants born at less than 28 weeks’ gestation. These infants were either mechanically ventilated or receiving noninvasive respiratory support and were being considered for surfactant treatment. Participants were randomized to receive either budesonide (0.25 mg/kg) mixed with surfactant (poractant alfa) or surfactant alone.
The primary outcome, survival free of BPD at 36 weeks’ postmenstrual age, occurred in 25.6% of infants in the budesonide and surfactant group and 22.6% in the surfactant-only group. This difference yielded an adjusted risk difference of 2.7% (95% CI, −2.1% to 7.4%), which was not statistically significant. Secondary outcomes, including survival at 36 weeks and BPD among survivors, also showed no significant differences between the two groups. Specifically, at 36 weeks’ postmenstrual age, 83.2% of infants were alive in the budesonide and surfactant group, compared to 80.6% in the surfactant-only group. Of these survivors, 69.3% and 71.9% were diagnosed with BPD, respectively.
The study's findings indicate that early intratracheal budesonide may have little to no effect on survival free of BPD in extremely preterm infants already receiving surfactant for respiratory distress syndrome. This suggests that the potential benefits of early intratracheal corticosteroid administration may be limited in this population.
BPD remains a significant challenge in extremely preterm infants, with systemic corticosteroids being an effective but potentially risky treatment option. While corticosteroids delivered directly to the lungs were hypothesized to be a safer alternative, this trial's results do not support this approach. The research team, led by investigators across the participating countries, emphasizes the need for continued research to identify effective strategies for preventing and managing BPD in this vulnerable population.
