Budesonide Surfactant Study: Impact on Preterm Infant BPD

Research conducted by the Royal Women's Hospital in Australia has provided new insights into the effectiveness of early intratracheal administration of budesonide, a steroid, mixed with surfactant in preventing bronchopulmonary dysplasia (BPD) in extremely preterm infants. This study is pivotal as BPD remains a common respiratory complication among this vulnerable population.

Understanding Bronchopulmonary Dysplasia

BPD is a severe lung condition that affects ~extremely preterm newborns, typically resulting from inadequate lung development and complications arising from respiratory distress syndrome (RDS). RDS itself affects preterm infants due to:

• Insufficient surfactant production: Surfactant is critical to reducing surface tension in the lungs, preventing collapse.
• Need for mechanical ventilation: Often required for survival, this can further contribute to lung injury and inflammation.
• Inflammatory responses: Interventions aimed at establishing adequate breathing can inadvertently cause damage to developing lungs.

Study Overview

The study, titled "Intratracheal Budesonide Mixed With Surfactant for Extremely Preterm Infants: The PLUSS Randomized Clinical Trial," published in JAMA, aimed to assess whether the combination of budesonide and surfactant improves survival rates free from BPD. Conducted as a double-masked randomized clinical trial, the research involved 1,059 infants born at less than 28 weeks of gestation across 21 neonatal units in Australia, New Zealand, Canada, and Singapore.

Methodology

Participants were randomized to receive either:

• Budesonide (0.25 mg/kg) combined with surfactant
• Surfactant alone

Administration occurred via an endotracheal tube or thin catheter shortly after birth, with the primary outcome measuring survival free of BPD by the 36-week postmenstrual age.

Results and Discussion

Results revealed that the incidence of BPD among participants was not significantly different. Specifically:

The adjusted risk difference was 2.7%, with a 95% confidence interval (–2.1% to 7.4%), indicating that the addition of budesonide did not provide a statistically significant benefit.

Both treatment groups exhibited high rates of BPD incidence among survivors, with 69.3% in the budesonide group and 71.9% in the surfactant-only group.

These findings diverge from earlier, smaller studies which hinted at potential advantages of budesonide in reducing BPD risk, underscoring the significance of larger sample sizes for a more accurate representation of treatment outcomes.

Implications for Clinical Practice

This research highlights a critical need for ongoing investigations into effective treatments for RDS and BPD as preterm birth rates continue to rise. The results indicate that while interventions have progressed, there remains a gap in effective strategies for improving outcomes in extremely preterm infants.

“As preterm births become more successful, we must pursue better and safer treatments for RDS and BPD to enhance the survival and quality of life for these infants.” – Dr. Brett J. Manley, Lead Researcher

Conclusion and Future Directions

The findings suggest that while the addition of intratracheal budesonide has yet to demonstrate effectiveness in preventing BPD, further research is essential. Future studies should aim to:

• Explore alternative combinations of therapies.
• Investigate long-term effects of current interventions on lung health.
• Assess other treatment windows that may yield better outcomes.

Ultimately, continued innovation and examination of therapeutic approaches are vital to improving care standards for extremely preterm infants facing significant health challenges.

References

[1] Manley, B. J., et al. (2024). Intratracheal Budesonide Mixed With Surfactant for Extremely Preterm Infants. JAMA.

[2] Jensen, E. A. (2024). Intratracheal Budesonide Combined With Surfactant in Extremely Preterm Infants. JAMA.

[3] Lifespan.io