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

NCT07100652 — Not applicable, Not yet recruiting, 384 participants, Jiulongpo No.1 People's Hospital

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

Registry	NCT07100652
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	384 (Estimated)
Sponsor	Jiulongpo No.1 People's Hospital (Other); collaborators: Jiangxi Maternal and Child Health Hospital
Conditions	Respiratory Distress Syndrome (&Amp; [Hyaline Membrane Disease])
Interventions	Threshold FiO₂ (Procedure)
Dates	start 2026-01-01 (estimated), primary completion 2027-02-01 (estimated), completion 2027-02-01 (estimated), first posted 2025-08-03, last updated 2025-08-03
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Lower oxygen threshold group (FiO₂ >0.25)	Experimental	Procedure: Threshold FiO₂	Surfactant was administered as a single initial dose when the fraction of inspired oxygen (FiO₂) exceeded 0.25
Higer oxygen threshold group (FiO₂ >0.3)	Active comparator	Procedure: Threshold FiO₂	Surfactant was administered as a single initial dose when the fraction of inspired oxygen (FiO₂) exceeded 0.3

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.

+Outcome measures

Primary outcomes

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

Secondary outcomes

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]
IVH > 2nd grade [3 mionths after birth]
hemodynamically significant patent ductus arteriosus (PDA) [3 months after birth]
weekly weight gain (in grams/d) for the first 4 weeks of life or until NICU discharge, whichever comes first. [3 months after birth]
Duration of non-invasive respiratory support [3 months after birth]
total hospitalization cost [6 months after birth]
nasal skin injury [3 months after birth]
in-hospital mortality [6 months after birth]
ventilator-free days [3 months after birth]

+Eligibility

Sex: All, ages: any to 3 Hours

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

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+Locations (1)

Facility	City	Country	Status
Jiangxi Maternal and Child Health Hospital	Nanchang, Jiangxi	China

+Publications

Results publication: 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