Early Surfactant Administration at FiO₂ >0.25 Under NIPPV for RDS in Very Preterm Infants

Comparing Different Oxygen Thresholds for Surfactant Administration During Nasal IPPV in Very Preterm Neonates With Respiratory Distress Syndrome: A Superiority RCT

This multicenter randomized controlled trial investigates whether initiating pulmonary surfactant (PS) at a lower oxygen threshold (FiO₂ >0.25) during nasal intermittent positive pressure ventilation (NIPPV) for very preterm infants with respiratory distress syndrome (RDS) reduces noninvasive ventilation failure rates (primary outcome: intubation requirement), compared to the standard threshold (FiO₂ >0.3). By establishing the clinical superiority of early PS administration, this study aims to refine evidence-based guidelines for RDS management in preterm neonates.

Inclusion Criteria:

• (1) Gestational Age: 26 weeks +0 day to 31 weeks+6days at birth (inclusive). (2) Clinical Diagnosis of NRDS: Symptoms: Tachypnea, grunting, and/or progressive respiratory distress. Imaging Findings: Chest X-ray showing at least one of: Ground-glass opacity, Air bronchograms, Diffuse "white lung" pattern, Lung Ultrasound (recommended).

  (3) Admission to NICU within 3 hours of birth. Requirement for non-invasive nasal intermittent positive pressure ventilation (NIPPV) at enrollment.

  (4) Signed informed consent obtained from parent(s) or legal guardian(s).

Exclusion Criteria:

1. Invasive mechanical ventilation during delivery or transport to NICU.

2. Structural upper airway abnormalities precluding non-invasive ventilation.

3. Confirmed diagnosis of major congenital malformations

4. Endotracheal intubation for indications unrelated to NRDS (e.g., surgery, sepsis management)

5. Initiation of non-invasive ventilation >3 hours post-birth.

6. Voluntary discharge or treatment withdrawal within 72 hours post-enrollment.

7. Parental/guardian refusal to Sign informed consent or Authorize surfactant administration

8. Incomplete clinical records or missing key outcome variables

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