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

N/ANot Yet RecruitingNCT07100652

Jiulongpo No.1 People's Hospital384 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

384

Conditions

Respiratory Distress Syndrome (&Amp; [Hyaline Membrane Disease])

Interventions

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.

Eligibility

Sex: ALLMax age: 3 Hours

Medical Language ↔ Plain English

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 \-

Outcomes

Primary Outcomes

Non-invasive respiratory support failure, defined by the need for IMV within 72 after birth

Time frame: 72 hours after birth

Secondary Outcomes

The requirement for repeated pulmonary surfactant administration, including the total number of doses utilized

Time frame: 7 days after birth

BPD, defined according to the NICHD definition