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Higher (40%) versus lower (30%) FiO

European journal of pediatrics2025-11-25PubMed
Total: 82.5Innovation: 8Impact: 0Rigor: 0Citation: 0

Summary

In a non-inferiority RCT of 205 preterm infants (26–32 weeks) on CPAP, initiating surfactant at FiO2 40% was non-inferior to 30% for total respiratory support time. The 40% threshold significantly reduced surfactant exposure without increasing BPD, air leaks, hsPDA, mortality, or length of stay.

Key Findings

  • A 40% FiO2 threshold was non-inferior to 30% for total duration of respiratory support.
  • Use of the 40% threshold significantly reduced surfactant exposure within 6 hours of birth.
  • No increase in adverse outcomes (BPD ≥2, air leaks, hsPDA requiring treatment, all-cause mortality, or hospital stay) was observed.
  • Subgroup analysis for 26–29 weeks' gestation was conducted.

Clinical Implications

For preterm infants (26–32 weeks) stabilized on CPAP, clinicians may consider a 40% FiO2 threshold for surfactant to reduce exposure without compromising outcomes, particularly in resource-limited settings.

Why It Matters

This trial directly tests a long-standing guideline threshold and shows a strategy to safely reduce surfactant use and workload. It is the first head-to-head RCT on FiO2 thresholds for surfactant.

Limitations

  • Modest sample size (N=205) may limit precision for rare adverse events.
  • Generalizability limited to CPAP-stabilized infants at 26–32 weeks' gestation.
  • Longer-term outcomes beyond hospitalization are not reported in the abstract.

Future Directions

Multicenter RCTs across broader gestational ages and care settings, with long-term respiratory and neurodevelopmental outcomes, to inform guideline updates.

Study Information

Study Type
RCT
Research Domain
Treatment
Evidence Level
I - Randomized controlled trial providing high-level evidence for intervention efficacy.
Study Design
OTHER