Early NCPAP Before Surfactant Treatment in Very Preterm Infants With RDS

November 21, 2013 updated by: Huiyi Huo, Xiangya Hospital of Central South University
We hypothesis a period of early NCPAP before surfactant treatment is effective for treating RDS and preventing BPD in very premature infants.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

683

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 minutes to 2 hours (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

inborn infants at 26-32 weeks gestation with RDS, whom received NCPAP as the initial treatment, followed by surfactant treatment within 24 h after birth

Description

Inclusion Criteria:

  • All enrolled infants were able to breathe at 5 min of age, had evidence of respiratory distress, unable to receive surfactant therapy, and were administrated with early NCPAP as the initial treatment

Exclusion Criteria:

  • Exclusion criteria were endotracheal intubation for resuscitation or insufficient respiratory drive, died in the first 24 hours after birth, known genetic disorders, potentially life-threatening conditions unrelated to prematurity, and premature rupture of membranes (PROM) for >3 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
<2h group
2-4h group
>4h group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
death or bronchopulmonary dysplasia
Time Frame: 24 hours after birth
24 hours after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 21, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (Estimate)

November 27, 2013

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

January 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • huohuiyi20131121
  • huo20131121 (Registry Identifier: huohuoyi)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bronchopulmonary Dysplasia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe