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

Jiulongpo No.1 People's Hospital

Status: Not yet enrolling

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

Treatments: Procedure: Threshold FiO₂

Study type: Interventional

Funder types: Other

Identifiers

NCT07100652

Jiangxi Maternal and Child

Details and patient eligibility

About

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.

Enrollment: 384 estimated patients

Sex: All

Ages: Under 3 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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384 participants in 2 patient groups

Lower oxygen threshold group (FiO₂ >0.25)

Experimental group

Description:

Surfactant was administered as a single initial dose when the fraction of inspired oxygen (FiO₂) exceeded 0.25

Treatment:

Procedure: Threshold FiO₂

Higer oxygen threshold group (FiO₂ >0.3)

Active Comparator group

Description:

Surfactant was administered as a single initial dose when the fraction of inspired oxygen (FiO₂) exceeded 0.3

Treatment:

Procedure: Threshold FiO₂