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Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome

NCT04984057 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-10-14

No results posted yet for this study

Summary

In preterm infants with neonatal respiratory distress syndrome (RDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal incidences of bronchopulmonary dysplasia(BPD) and/or death. But not all preterm infants with RDS can be beneficial. Otherwise, the international neonatal acute RDS (NARDS) collaborative group provides the first consensus definition for NARDS in 2017. And whether or not PS being beneficial in preterm infants with NARDS remains unknown.

Conditions

  • Respiratory Distress Syndrome, Newborn
  • Patent Ductus Arteriosus
  • Bronchopulmonary Dysplasia
  • Preterm

Interventions

DRUG

PS is stopped when the pressure is equal between bPDA and aPDA.

PS is given and stopped when the pressure is equal between bPDA and aPDA. the pressure is measured using ultrasound

DRUG

PS is given according to the 2019 European RDS management guideline

PS is given according to the 2019 European RDS management guideline

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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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 NCT04984057 on ClinicalTrials.gov