Intratracheal budesonide improves survival in preterm infants with bronchopulmonary dysplasia: Study

A recent clinical trial published in the Journal of American Medical Association found the potential of early intratracheal budesonide administration to improve outcomes in extremely preterm infants at risk of bronchopulmonary dysplasia (BPD). The study spanned across neonatal units in Australia, New Zealand, Canada, and Singapore on infants born before 28 weeks of gestation to evaluate whether adding budesonide to surfactant treatment could enhance survival without BPD.

This study was conducted between January 2018 and March 2023, and involved a total of 1059 infants under 48 hours old. The participants, who were on mechanical ventilation or receiving noninvasive respiratory support requiring surfactant, were randomly assigned to one of two groups. The intervention group received a mixture of budesonide (0.25 mg/kg) and surfactant (poractant alfa) via an endotracheal tube or thin catheter. The control group received surfactant alone.

Survival without BPD at 36 weeks’ postmenstrual age was the primary outcome and this showed modest results. Among the budesonide group, 25.6% of infants survived without BPD compared to 22.6% in the surfactant-only group. This yielded an adjusted risk difference of 2.7%, with a confidence interval indicating no statistically significant difference (-2.1% to 7.4%).

Survival rates at 36 weeks were slightly higher in the budesonide group (83.2%) versus the surfactant-only group (80.6%). However, rates of BPD among survivors were similar, with 69.3% of the budesonide group and 71.9% of the control group diagnosed with the condition.

Secondary safety analyses reviewed adverse events but did not show significant differences between groups. The findings suggest that while the intratracheal administration of budesonide is safe and offers limited improvement in clinical outcomes regarding BPD prevention.

While the addition of budesonide to surfactant therapy demonstrated safety, its marginal effect on reducing BPD suggests that alternative strategies may be necessary to improve outcomes in this vulnerable population. Overall, the study illuminates the complexities of treating respiratory distress syndrome in preterm infants and the need for further exploration of effective therapies.

Reference:

Manley, B. J., Kamlin, C. O. F., Donath, S. M., Francis, K. L., Cheong, J. L. Y., Dargaville, P. A., Dawson, J. A., Jacobs, S. E., Birch, P., Resnick, S. M., Schmölzer, G. M., Law, B., Bhatia, R., Bach, K. P., de Waal, K., Travadi, J. N., Koorts, P. J., Berry, M. J., Lui, K., … Jeong, W. (2024). Intratracheal Budesonide Mixed With Surfactant for Extremely Preterm Infants. In JAMA (Vol. 332, Issue 22, p. 1889). American Medical Association (AMA). https://doi.org/10.1001/jama.2024.17380