by Justin Jackson , Medical Xpress

Credit: Pixabay/CC0 Public Domain

Research led by the Royal Women's Hospital, Australia, has found that early intratracheal administration of budesonide mixed with surfactant may have little to no effect on improving survival free of bronchopulmonary dysplasia (BPD) in extremely preterm infants.

BPD is a respiratory complication of extremely preterm newborns due to reduced blood flow and gas exchange of oxygen and carbon dioxide as the lungs develop, often resulting from lung injury during the treatment of respiratory distress syndrome (RDS).

RDS is a breathing problem that can affect preterm babies born six weeks or more prematurely. Since their lungs are not developed enough to make surfactant, a liquid coating inside of the lungs, they struggle to keep them open. Common treatments for RDS are ventilators or surfactant replacement to get things started in the right direction.

RDS and the interventions to get the child breathing properly can cause some damage and inflammation to the lungs, resulting in BPD. While RDS typically develops within the first 24 hours, BPD can show up a week or two later.

In a paper titled "Intratracheal Budesonide Mixed With Surfactant for Extremely Preterm Infants: The PLUSS Randomized Clinical Trial," published in JAMA, researchers investigated the effectiveness of early intratracheal corticosteroid administration on survival free of BPD in extremely preterm infants in a double-masked randomized clinical trial. An Editorial on the study by Erik Jensen is published in the same journal issue.

The multi-site Preventing Lung Disease Using Surfactant + Steroid (PLUSS) trial took place at 21 neonatal units in four countries (Australia, New Zealand, Canada, and Singapore), with 1,059 infants. All were born at less than 28 weeks gestation and were less than 48 hours old. Some were mechanically ventilated, while others received noninvasive respiratory support and had a clinical decision to treat with surfactant.

Participants were randomly assigned to receive either a steroid (budesonide, 0.25 mg/kg) mixed with surfactant or surfactant alone, administered via an endotracheal tube or thin catheter. The primary outcome measured was survival free of BPD at their expected 36-week postmenstrual mark.

Results indicated that 25.6% of infants in the budesonide and surfactant group survived without BPD, compared to 22.6% in the surfactant-only group. The adjusted risk difference was 2.7%, with a 95% confidence interval ranging from –2.1% to 7.4%. Since the confidence interval includes zero, there is no statistically significant difference between the two groups.

At the 36-week postmenstrual point, survival rates were similar, with 83.2% in the budesonide group and 80.6% in the surfactant-only group. Among survivors, the incidence of BPD remained high in both groups, at 69.3% and 71.9%, respectively.

These findings contrast with earlier, smaller studies that suggested a potential benefit of intratracheal budesonide in reducing BPD risk. The current study's larger sample size and inclusion of infants receiving noninvasive respiratory support provide a more comprehensive assessment of the intervention's effectiveness.

Preterm births are far more successful now than ever before, and with better infant survival rates comes the need for better RDS and BPD treatments. Unfortunately, this study indicates we have not yet found that better solution.

More information: Brett J. Manley et al, Intratracheal Budesonide Mixed With Surfactant for Extremely Preterm Infants, JAMA (2024). DOI: 10.1001/jama.2024.17380

Erik A. Jensen, Intratracheal Budesonide Combined With Surfactant in Extremely Preterm Infants, JAMA (2024). DOI: 10.1001/jama.2024.19641

Journal information: Journal of the American Medical Association 

© 2024 Science X Network