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Intratracheal Budesonide Mixed With Surfactant for Extremely Preterm Infants: The PLUSS Randomized Clinical Trial
Brett J Manley1,2,3, C Omar F Kamlin1,2, Susan M Donath3,4
1Newborn Research, The Royal Women's Hospital, Melbourne, Victoria, Australia.
JAMA
|November 11, 2024
Summary
Early intratracheal budesonide in extremely preterm infants did not significantly improve survival free of bronchopulmonary dysplasia (BPD). This study suggests limited benefit for this intervention in preventing BPD in high-risk newborns.
Area of Science:
- Neonatal Medicine
- Pediatric Pulmonology
- Clinical Trials
Background:
- Bronchopulmonary dysplasia (BPD) is a frequent complication in extremely preterm infants.
- Systemic corticosteroids are effective for BPD but carry risks.
- Intrapulmonary corticosteroids offer a potential safer alternative.
Purpose of the Study:
- To evaluate the efficacy of early intratracheal budesonide administration.
- To assess the impact on survival free of BPD at 36 weeks' postmenstrual age.
- To investigate safety outcomes of this intervention.
Main Methods:
- A double-blind, randomized clinical trial involving 1059 extremely preterm infants (<28 weeks' gestation).
- Infants received either budesonide with surfactant or surfactant alone.
- The primary outcome was survival free of BPD at 36 weeks' postmenstrual age.
Main Results:
- Survival free of BPD occurred in 25.6% with budesonide vs. 22.6% without (adjusted risk difference: 2.7%; 95% CI, -2.1% to 7.4%).
- Overall survival at 36 weeks' postmenstrual age was 83.2% with budesonide and 80.6% without.
- No significant difference in BPD rates among survivors was observed.
Conclusions:
- Early intratracheal budesonide administration showed little to no effect on survival free of BPD in extremely preterm infants.
- The findings suggest that this intervention may not be beneficial for preventing BPD.
- Further research may be needed to explore alternative strategies for BPD prevention.
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