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NCT Number: NCT07100652

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

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.

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Key information

Conditions

Respiratory Distress Syndrome (&Amp; [Hyaline Membrane Disease]) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyaline Membrane Disease Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases

Age range

Up to 3 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

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Treatment and study plan

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.

Primary outcomes

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

    Time frame: 72 hours after birth

Secondary outcomes

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

    Time frame: 7 days after birth

  2. BPD, defined according to the NICHD definition

    Time frame: 3 months after birth

  3. airleaks occurred after the extubation

    Time frame: 3 months after birth

  4. retinopathy of prematurity (ROP) > 2nd stage

    Time frame: 3 months after birth

  5. necrotizing enterocolitis (NEC) ≥ 2nd stage

    Time frame: 3 months after birth

  6. IVH > 2nd grade

    Time frame: 3 mionths after birth

  7. hemodynamically significant patent ductus arteriosus (PDA)

    Time frame: 3 months after birth

  8. weekly weight gain (in grams/d) for the first 4 weeks of life or until NICU discharge, whichever comes first.

    Time frame: 3 months after birth

  9. Duration of non-invasive respiratory support

    Time frame: 3 months after birth

  10. total hospitalization cost

    Time frame: 6 months after birth

  11. nasal skin injury

    Time frame: 3 months after birth

  12. in-hospital mortality

    Time frame: 6 months after birth

  13. ventilator-free days

    Time frame: 3 months after birth

Study contacts

Contact information is provided by the study sponsor or research team.

Yuan Shi, PhD

CONTACT

[email protected]

0791-86224432

Sponsors and collaborators

Lead sponsor

Jiulongpo No.1 People's Hospital

Other

Collaborators

  • Jiangxi Maternal and Child Health Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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