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

NCT04777760 | Recruiting DMC

• 1 other identifier: surfactant for NRDS and ARDS
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Distress Syndrome; Preterm Birth; Acute Respiratory Distress Syndrome; Surfactant Dysfunction

Outcome Measures

Primary Outcomes (5)

• bronchopulmonary dysplasia(BPD)

  the preterm infants will be diagnosed with BPD

  at 36 weeks' gestational age or before discharge from hospital

• death

  the preterm infants die

  at 36 weeks' gestational age or before discharge from hospital

• BPD and/or death

  the preterm infants will be diagnosed with BPD and/or death

  at 36 weeks' gestational age or before discharge from hospital

• the predictive powers of one dose of surfactant to diagnose NRDS

  the sensitivity and accuracy of one dose of surfactant to diagnose NRDS

  seven days after birth

• the predictive powers of two and more doses of surfactant to diagnose NARDS

  the sensitivity and accuracy of two and more doses of surfactant to diagnose NARDS

  seven days after birth

Secondary Outcomes (6)

• intraventricular hemorrhage(IVH)

  before discharge or 36 weeks' gestational age

• air leak

  at 36 weeks' gestational age or before discharge from hospital

• periventricular leukomalacia(PVL)

  at 36 weeks' gestational age or before discharge from hospital

• necrotizing enterocolitis(NEC)

  at 36 weeks' gestational age or before discharge from hospital

• patent ductus arteriosis(PDA)

  at 36 weeks' gestational age or before discharge from hospital

Study Arms (2)

one dose of surfactant

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

Drug: one dose of surfactant replacement

two and more doses of surfactant

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

Drug: two and more doses of surfactant replacement

Interventions

one dose of surfactant replacement DRUG

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

one dose of surfactant

two and more doses of surfactant replacement DRUG

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

two and more doses of surfactant

Eligibility Criteria

• Age: 1 Minute - 24 Hours
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Preterm infants diagnosed with NRDS or NARDS were eligible. The diagnosis of NARDS was according to the criteria established by Montreux conference in 2017.The diagnosis of NRDS was according to the criteria established by European Consensus Guideline for the management of NRDS in 2019

You may qualify if:

• 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

You may not qualify if:

• one of the following criteria will be needed
• major congenital anomalies
• chromosomal abnormalities
• upper respiratory tract abnormalities

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead
• Children's Hospital of Chongqing Medical University: collaborator

Study Sites (1)

Chen

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Premature Birth; Surfactant Dysfunction

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Chen Long, MD, PhD

CONTACT

+8613883559467; neuroclong@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 2, 2021
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: preliminary estimate in 2025

Locations

CN (1)