Intratracheal Administration of Budesonide with Surfactant for Prevention of Death or Bronchopulmonary Dysplasia in Extremely Low Birth Weight Infants: A before–after Study

Abstract

Objective

Previous studies have suggested a potential role for inhaled corticosteroids, such as budesonide, in reducing bronchopulmonary dysplasia (BPD) among preterm infants. The objective of our study was to investigate the effectiveness of intratracheal administration of corticosteroid with surfactant on the composite outcome of death or BPD at 36 weeks in extremely low birth weight (ELBW) infants.

Study Design

This before–after cohort study compared outcomes in ELBW infants with respiratory distress syndrome (RDS) who received intratracheal surfactant with budesonide to a historical cohort who received surfactant alone. Data were collected retrospectively for neonates in the surfactant group and prospectively for those receiving surfactant plus budesonide.

Results

A total of 385 ELBW infants were included. Death or BPD occurred in 123/203 (60.5%) in the surfactant with budesonide group versus 105/182 (57.6%) in the surfactant group; adjusted odds ratio 1.10 (95% CI: 0.69–1.75; p = 0.69). Statistical analysis revealed no significant difference in the incidence of the composite primary outcome (death or BPD at 36 weeks of postmenstrual gestational age), and its components, between the two study groups.

Conclusion

In our study, coadministration of budesonide and surfactant was deemed safe and feasible among ELBW infants with RDS. However, we did not observe a significant reduction in the rates of composite or individual outcomes of death or BPD. Larger, randomized controlled trials are necessary to explore the potential advantages of this intervention.

Key Points

• Small clinical trials have shown promising benefits of intratracheal administration of budesonide with surfactant for improving respiratory outcomes in preterm infants.

• This before–after intervention study showed that intratracheal budesonide with surfactant was safe and feasible in ELBW infants.

• However, coadministration of budesonide and surfactant did not reduce the composite outcome of death or BPD in the study population.

Keywords

premature - bronchopulmonary dysplasia - BPD - budesonide

Authors' Contributions

A.P. and N.K. contributed to the study conception and design. Material preparation and data collection were done by S.K., A.C., and R.C. Data analysis was performed by D.T., S.S., and H.B. The first draft of the manuscript was written by S.K. and A.C. N.K. and A.P. supervised the data collection and statistical analysis. All authors reviewed the manuscript and commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Publication History

Received: 22 October 2024

Accepted: 18 December 2024

Accepted Manuscript online:
19 December 2024

Article published online:
21 January 2025

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