NHFOV as Primary Support in Very Preterm Infants With RDS
Description
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.
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Study detailes are available at: - Clinicaltrials.gov: NCT05141435 - Protocol was published at：Li Y, Zhu X, Shi Y, et al. Non-invasive high-frequency oscillatory ventilation versus nasal continuous positive airway pressure in extremely preterm infants with respiratory distress syndrome: study protocol for a multicentre randomised controlled, superiority trial. BMJ Open 2023;13:e068450.
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Funding
Chongqing Science and Technology Commission
CSTB2024NSCQ-MSX0158
National Key Research and Development Program of China
No.2022YFC2704803