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

NCT07100652 | Not Yet Recruiting DMC

• 1 other identifier: Jiangxi Maternal and Child
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  72 hours after birth

Secondary Outcomes (13)

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

  7 days after birth

• BPD, defined according to the NICHD definition

  3 months after birth

• airleaks occurred after the extubation

  3 months after birth

• retinopathy of prematurity (ROP) > 2nd stage

  3 months after birth

• necrotizing enterocolitis (NEC) ≥ 2nd stage

  3 months after birth

Study Arms (2)

Lower oxygen threshold group (FiO₂ >0.25)

EXPERIMENTAL

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

Procedure: Threshold FiO₂

Higer oxygen threshold group (FiO₂ >0.3)

ACTIVE COMPARATOR

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

Procedure: Threshold FiO₂

Interventions

Threshold FiO₂ PROCEDURE

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.

Higer oxygen threshold group (FiO₂ >0.3); Lower oxygen threshold group (FiO₂ >0.25)

Eligibility Criteria

• Age: Up to 3 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• (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).

You may not qualify if:

• Invasive mechanical ventilation during delivery or transport to NICU.
• Structural upper airway abnormalities precluding non-invasive ventilation.
• Confirmed diagnosis of major congenital malformations
• Endotracheal intubation for indications unrelated to NRDS (e.g., surgery, sepsis management)
• Initiation of non-invasive ventilation \>3 hours post-birth.
• Voluntary discharge or treatment withdrawal within 72 hours post-enrollment.
• Parental/guardian refusal to Sign informed consent or Authorize surfactant administration
• Incomplete clinical records or missing key outcome variables

Sponsors & Collaborators

• Jiulongpo No.1 People's Hospital: lead
• Jiangxi Maternal and Child Health Hospital: collaborator

Study Sites (1)

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, China

Location

Related Publications (1)

• Yang R, Fang Z, Liu KZ, Zhu X, Ding XP, Luo Q, Zhou WJ, Hu XW, Zhou JL, Tang WY, Shi Y. Comparison of two fractions of inspired oxygen thresholds (0.25 vs 0.30) for surfactant administration in very preterm infants with respiratory distress syndrome under nasal intermittent positive pressure ventilation: study protocol for a multicentre randomised controlled, superiority trial. BMJ Paediatr Open. 2025 Nov 10;9(1):e003998. doi: 10.1136/bmjpo-2025-003998.

  PMID: 41213831 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Hyaline Membrane Disease

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Distress Syndrome, Newborn; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Yuan Shi, PhD

CONTACT

0791-86224432; shiyuan@hospital.cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jiangxi Maternal and Child Health Hospital, Jiangxi, 337000, China

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 3, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)