Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)

NCT04777760 · tracked via the Priya Life Science China tracker

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Phase

Observational

Started

2021-01-01

Last updated

2025-07-01

Condition(s) studied

Respiratory Distress SyndromePreterm BirthAcute Respiratory Distress SyndromeSurfactant Dysfunction

Investigational drug(s) / intervention(s)

one dose of surfactant replacementtwo and more doses of surfactant replacement

one dose of surfactant replacement: the preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant

two and more doses of surfactant replacement: the preterm infants diagnosed with NRDS and/or NARDS will be administrated with two and more doses of surfactant

Study summary

In preterm infants with neonatal respiratory distress syndrome (NRDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal mortality. Nowadays, PS is commonly used in newborn infants with respiratory distress, but the incidences of bronchopulmonary dysplasia(BPD) and/or death are inconsistent. The result indicates that not all preterm infants with respiratory distress can be beneficial from PS.

In 2017, the international neonatal ARDS (NARDS) collaborative group provides the first consensus definition for NARDS. And whether or not PS being beneficial for preterm infants with NARDS remains unknown.

Eligibility

Sex

ALL

Min age

1 Minute

Max age

24 Hours

Healthy volunteers

Inclusion Criteria: Eligibility requirements for neonates were as follows: * The gestational age is less than 37 weeks and admitted to neonatal intensive care unit(NICU) in 24 h after birth * The neonates will be diagnosed with NRDS or NARDS * The neonates will be at least administrated one dose of surfactant Exclusion Criteria: one of the following criteria will be needed * major congenital anomalies * chromosomal abnormalities * upper respiratory tract abnormalities

Primary outcome measure(s)

bronchopulmonary dysplasia(BPD) — at 36 weeks' gestational age or before discharge from hospital
the preterm infants will be diagnosed with BPD
death — at 36 weeks' gestational age or before discharge from hospital
the preterm infants die
BPD and/or death — at 36 weeks' gestational age or before discharge from hospital
the preterm infants will be diagnosed with BPD and/or death
the predictive powers of one dose of surfactant to diagnose NRDS — seven days after birth
the sensitivity and accuracy of one dose of surfactant to diagnose NRDS
the predictive powers of two and more doses of surfactant to diagnose NARDS — seven days after birth
the sensitivity and accuracy of two and more doses of surfactant to diagnose NARDS

Trial sites (1)

Facility	City	Region	Status
Chen	Chongqing	Chongqing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04777760 on ClinicalTrials.gov ↗ ← All trials in China