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Budesonide and Surfactant Therapy Versus Surfactant Alone on Incidence of Lung Disease in Preterm Infants (BEST

James X Sotiropoulos1, Brett J Manley2,3,4, Sol Libesman1

  • 1NHMRC Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.

Acta Paediatrica (Oslo, Norway : 1992)
|June 15, 2026
PubMed

Insights

This study will analyze individual patient data from randomized controlled trials to determine if surfactant combined with budesonide effectively prevents bronchopulmonary dysplasia (BPD) in preterm infants. The goal is to clarify conflicting results and improve infant survival rates.

Area of Science:

  • Neonatal Medicine
  • Pediatric Pulmonology
  • Evidence Synthesis

Background:

  • Bronchopulmonary dysplasia (BPD) significantly impacts preterm infant morbidity and mortality.
  • Current randomized controlled trials (RCTs) on surfactant plus budesonide for BPD prevention show conflicting results.
  • Individual participant data meta-analysis (IPD-MA) offers enhanced precision and subgroup analysis capabilities.

Purpose of the Study:

  • To conduct an IPD-MA investigating the efficacy of surfactant plus budesonide versus surfactant alone in preventing BPD.
  • To analyze raw data from RCTs for improved accuracy and data quality assessment.
  • To explore potential subgroup effects and treatment-covariate interactions.

Main Methods:

  • Systematic search of medical databases and trial registers for relevant RCTs.
  • Inclusion of preterm infants (<32 weeks gestation) randomized to surfactant alone or surfactant plus budesonide.
  • Exclusion of studies with major quality concerns; risk of bias assessed using Cochrane's RoB 2 tool.
  • Two-stage fixed-effects IPD-MA with co-primary outcomes: mortality and BPD at 36 weeks postmenstrual age.
  • GRADE assessment for certainty of evidence and a nested prospective meta-analysis.

Main Results:

  • The IPD-MA will provide precise estimates of treatment effects.
  • Subgroup analyses will identify patient populations who benefit most from surfactant plus budesonide.
  • The study aims to resolve conflicting findings from previous RCTs.

Conclusions:

  • Surfactant plus budesonide, if effective, represents a low-cost intervention to reduce BPD and improve survival in preterm infants.
  • IPD-MA will offer deeper insights into the treatment's effectiveness and potential benefits.
Abstract

Keywords:
bronchopulmonary dysplasiabudesonideindividual participant data meta‐analysissteroidssurfactant

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