Threshold FiO₂: Group 1 (Intervention Group) received the initial dose of pulmonary surfactant immediately upon reaching an inhaled oxygen concentration (FiO₂) \>0.25.
Group 2 (Control Group) received the initial dose of pulmonary surfactant as early as possible within 48 hours, but only when FiO₂ was titrated to \>0.3 based on the infant's clinical condition.
Study summary
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.
Eligibility
Sex
ALL
Min age
—
Max age
3 Hours
Healthy volunteers
No
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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Primary outcome measure(s)
Non-invasive respiratory support failure, defined by the need for IMV within 72 after birth — 72 hours after birth
Trial sites (1)
Facility
City
Region
Status
Jiangxi Maternal and Child Health Hospital
Nanchang
Jiangxi
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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