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