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Supplemental oxygen strategies in infants with bronchopulmonary dysplasia after the neonatal intensive care unit
Stephanie Balink1, Wes Onland2,3, Elianne J L E Vrijlandt4
1Department of Paediatrics/Paediatric Respiratory Medicine, Erasmus MC Sophia Children Hospital, Rotterdam, The Netherlands.
Insights
This study investigates optimal oxygen saturation levels for preterm infants with bronchopulmonary dysplasia (BPD) after 36 weeks postmenstrual age. Comparing higher (≥95%) versus lower (≥90%) limits aims to improve infant outcomes and guide treatment strategies.
Area of Science:
- Neonatology
- Pediatric Pulmonology
- Critical Care Medicine
Background:
- Supplemental oxygen is crucial for preterm infants with bronchopulmonary dysplasia (BPD).
- Optimal oxygen saturation targets for infants with established BPD from 36 weeks postmenstrual age (PMA) onwards remain unclear.
- This uncertainty impacts clinical management and long-term infant outcomes.
Purpose of the Study:
- To compare the efficacy of a higher oxygen saturation limit (≥95%) versus a lower limit (≥90%) in preterm infants with moderate to severe BPD after 36 weeks PMA.
- To determine the optimal oxygen saturation threshold for improving outcomes in this vulnerable population.
- To inform evidence-based guidelines for respiratory support in infants with BPD.
Main Methods:
- A non-blinded, multicentre, randomized controlled trial involving 198 preterm infants (36-38 weeks PMA) with moderate or severe BPD.
- Infants randomized to either a lower saturation limit of 95% or 90%.
- Primary outcome: weight standard deviation (SD) score at 6 months corrected age; secondary outcomes: anthropometrics, rehospitalizations, respiratory symptoms, infant stress, parental quality of life, and cost-effectiveness.
Main Results:
- Data on primary and secondary outcomes are currently being collected and analyzed.
- The study aims to provide robust evidence on the impact of different oxygen saturation targets.
- Findings will elucidate the effects on growth, morbidity, and overall well-being.
Conclusions:
- The study is expected to establish optimal oxygen saturation targets for preterm infants with BPD beyond 36 weeks PMA.
- Results will guide clinical practice, potentially improving long-term respiratory and developmental outcomes.
- This research addresses a critical knowledge gap in neonatal respiratory care.
Introduction:
Supplemental oxygen is the most important treatment for preterm born infants with established bronchopulmonary dysplasia (BPD). However, it is unknown what oxygen saturation levels are optimal to improve outcomes in infants with established BPD from 36 weeks postmenstrual age (PMA) onwards. The aim of this study is to compare the use of a higher oxygen saturation limit (≥95%) to a lower oxygen saturation limit (≥90%) after 36 weeks PMA in infants diagnosed with moderate or severe BPD.
Methods And Analysis:
This non-blinded, multicentre, randomised controlled trial will recruit 198 preterm born infants with moderate or severe BPD between 36 and 38 weeks PMA. Infants will be randomised to either a lower oxygen saturation limit of 95% or to a lower limit of 90%; supplemental oxygen and/or respiratory support will be weaned based on the assigned lower oxygen saturation limit. Adherence to the oxygen saturation limit will be assessed by extracting oxygen saturation profiles from pulse oximeters regularly, until respiratory support is stopped. The primary outcome is the weight SD score at 6 months of corrected age. Secondary outcomes include anthropometrics collected at 6 and 12 months of corrected age, rehospitalisations, respiratory complaints, infant stress, parental quality of life and cost-effectiveness.
Ethics And Dissemination:
Ethical approval for the trial was obtained from the Medical Ethics Review Committee of the Erasmus University Medical Centre, Rotterdam, the Netherlands (MEC-2018-1515). Local approval for conducting the trial in the participating hospitals has been or will be obtained from the local institutional review boards. Informed consent will be obtained from the parents or legal guardians of all study participants.
Trial Registration Number:
NL7149/NTR7347.
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