Non-invasive high frequency oscillatory ventilation for primary respiratory support in extremely preterm infants: multicentre randomised controlled trial.

Summary

In 342 extremely preterm infants with respiratory distress syndrome, NHFOV reduced the need for invasive ventilation within 72 hours compared with NCPAP (15.9% vs 27.9%; risk difference −12.0 percentage points; P=0.007). Benefits persisted through seven days, with no increase in adverse neonatal outcomes, supporting NHFOV as a primary non-invasive strategy.

Key Findings

• NHFOV lowered treatment failure within 72 hours versus NCPAP (15.9% vs 27.9%; risk difference −12.0 percentage points; 95% CI −20.7 to −3.4; P=0.007).
• Treatment failure within seven days was also reduced in the NHFOV group (risk difference −12.5 percentage points; 95% CI −21.9 to −3.2; P=0.008).
• No significant differences were observed in other neonatal adverse events; results were robust in sensitivity analyses accounting for sites and antenatal steroids.

Clinical Implications

Consider NHFOV as a primary non-invasive respiratory support option for extremely preterm infants to reduce early intubation, while monitoring for equivalent safety profiles to NCPAP.

Limitations

• Open-label design may introduce performance bias
• Conducted in Chinese NICUs; generalizability to other settings and long-term outcomes (e.g., BPD, neurodevelopment) were not established

Future Directions

Evaluate NHFOV in broader healthcare settings, assess long-term respiratory and neurodevelopmental outcomes, and optimize device settings for efficacy and safety.