Early Surfactant Administration at FiO₂ >0.25 Under NIPPV for RDS in Very Preterm Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Threshold FiO₂.
- Who it may be relevant to
- Registry conditions: Respiratory Distress Syndrome (&Amp; [Hyaline Membrane Disease]). Basic parameters: up to 3 Hours · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparing Different Oxygen Thresholds for Surfactant Administration During Nasal IPPV in Very Preterm Neonates With Respiratory Distress Syndrome: A Superiority RCT
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.
Interventions
- Procedure 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.
Primary outcome measures
- Non-invasive respiratory support failure, defined by the need for IMV within 72 after birth [Time frame: 72 hours after birth]
Secondary outcome measures (12)
- 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 [Time frame: 3 months after birth]
- airleaks occurred after the extubation [Time frame: 3 months after birth]
- retinopathy of prematurity (ROP) > 2nd stage [Time frame: 3 months after birth]
- necrotizing enterocolitis (NEC) ≥ 2nd stage [Time frame: 3 months after birth]
- IVH > 2nd grade [Time frame: 3 mionths after birth]
- hemodynamically significant patent ductus arteriosus (PDA) [Time frame: 3 months after birth]
- 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]
- Duration of non-invasive respiratory support [Time frame: 3 months after birth]
- total hospitalization cost [Time frame: 6 months after birth]
- nasal skin injury [Time frame: 3 months after birth]
- in-hospital mortality [Time frame: 6 months after birth]
Eligibility criteria
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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Jiangxi Maternal and Child Health Hospital — Nanchang
Publications
- 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. PMID 41213831
Identifiers
NCT: NCT07100652 · Jiangxi Maternal and Child