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

NCT04777760 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-07-01

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

one dose of surfactant replacement

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

DRUG

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

Sponsors & Collaborators

  • Children's Hospital of Chongqing Medical University

    collaborator OTHER

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

    lead OTHER

Eligibility

Min Age
1 Minute
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04777760 on ClinicalTrials.gov