NHFOV as Primary Support in Very Preterm Infants With RDS

Study Design
This was a prospective, multicenter, superiority-design RCT conducted in China (Aug 2022–Aug 2024) comparing NHFOV vs. nCPAP as primary NIV for RDS in infants <28 weeks’ GA.

Primary Outcome
Respiratory support failure (need for IMV within 72h), defined by:

Severe respiratory acidosis (PaCO₂ >60 mmHg + pH <7.2, ≥1h)

Refractory hypoxia (SpO₂ <90% at FiO₂ 0.4, ≥1h post-surfactant)

Severe apnea (>3 episodes/hr with HR <100/min or bag-mask rescue)

Clinician-determined urgent intubation

Secondary Outcomes
IMV need within 7 days

BPD at 36 weeks, hsPDA, ROP >stage 2, NEC ≥stage 2, IVH ≥grade 3

Composite mortality/BPD, weight gain, respiratory/O₂ support duration

Safety & Adverse Events
Death, pneumothorax, airway obstruction, severe nasal injury (grade III–IV)

No protocol modifications or treatment-related SAEs observed

Participants
Screened: 729 → Eligible: 405 → Randomized: 360 → Final cohort: 342 (18 excluded due to consent withdrawal)

Balanced baseline characteristics

Key Finding
NHFOV significantly reduced early treatment failure vs. nCPAP, with comparable safety.

Dataset
Includes patient/center IDs, baseline characteristics, primary/secondary outcomes, and SAEs.