Nasal Continuous Positive Airway Pressure vs Nasal Intermittent Positive Pressure Ventilation in Preterm Infants With Respiratory Distress Syndrome: A Randomized Clinical Trial.

Summary

In a multicenter noninferiority RCT of 312 extremely preterm infants with RDS receiving early MISA, initial NIPPV halved NIV failure within 72 hours versus NCPAP and remained superior at 7 days, without excess complications. Early stopping on prespecified criteria supports robustness, but long-term outcomes remain to be assessed.

Key Findings

• NIV failure within 72 hours: 26.1% with NCPAP vs 13.2% with NIPPV; adjusted risk difference 12.8% (95% CI, 4.2%-21.6%; P=.004).
• NIV failure within 7 days: 27.5% with NCPAP vs 15.1% with NIPPV; risk difference 12.4% (95% CI, 3.4%-21.4%; P=.008).
• No significant between-group differences in major complications (e.g., pneumothorax, BPD).
• Trial stopped early at 312 of planned 960 based on prespecified O'Brien-Fleming criteria; registered (NCT05137340).

Clinical Implications

For extremely preterm infants with RDS receiving early MISA, NIPPV should be preferred over NCPAP as initial respiratory support to reduce early intubation; clinicians should still monitor for long-term outcomes given early trial termination.

Limitations

• Early termination may limit precision and assessment of longer-term outcomes.
• Open-label nature and setting limited to Chinese tertiary NICUs may affect generalizability.

Future Directions

Assess neurodevelopmental and respiratory outcomes beyond discharge, evaluate protocolized NIPPV settings, and replicate in diverse health systems.