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Supplemental Oxygen Strategies in children with BronchoPulmonary Dysplasia (the SOS BPD study): statistical analysis

Rosemarie de Ridder1,2, Maruschka P Merkus3,4, Elianne J L E Vrijlandt5

  • 1Department of Paediatrics, Division of Neonatology, Emma Children's Hospital, Amsterdam University Medical Centers, Amsterdam, The Netherlands.

Trials
|June 12, 2026
PubMed

Insights

This study compares higher versus lower oxygen saturation targets in preterm infants with bronchopulmonary dysplasia (BPD). It aims to determine the impact on infant growth and respiratory outcomes.

Area of Science:

  • Neonatology
  • Pediatric Pulmonology
  • Clinical Trials

Background:

  • Bronchopulmonary dysplasia (BPD) is a chronic lung disease in preterm infants.
  • Supplemental oxygen is the main treatment for BPD.
  • Current evidence on optimal oxygen saturation targets in BPD beyond 36 weeks postmenstrual age is limited.

Purpose of the Study:

  • To evaluate the effect of higher (95%) versus lower (90%) oxygen saturation targets on lung growth in infants with BPD.
  • To assess the impact on weight standard deviation score (SDS) at 6 months corrected age.
  • To analyze secondary outcomes including anthropometrics and respiratory rehospitalizations.

Main Methods:

  • A multicenter, pragmatic, non-blinded randomized trial involving preterm infants with moderate to severe BPD.
  • Infants randomized between 36-38 weeks postmenstrual age to either 95% or 90% oxygen saturation lower limit.
  • Primary outcome: weight SDS at 6 months corrected age; secondary outcomes: anthropometrics, rehospitalizations.

Main Results:

  • This document outlines the statistical analysis plan and does not contain results.
  • The study is registered (NL-OMON54694) and data analysis will be performed without prior knowledge of the data.

Conclusions:

  • The statistical analysis plan is detailed to ensure rigorous evaluation of the study's primary and secondary outcomes.
  • Findings will inform optimal oxygenation strategies for preterm infants with BPD, potentially improving long-term respiratory health.
Abstract

Keywords:
Bronchopulmonary dysplasiaNeonatal intensive care unitOxygen saturation limitPrematurityStatistical analysis planSupplemental oxygen

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