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NCT01996670 Clinical Trial

Early NCPAP Before Surfactant Treatment in Very Preterm Infants With RDS

Bronchopulmonary Dysplasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01996670
Other study ID # huohuiyi20131121
Secondary ID huo20131121
Status Completed
Phase N/A
First received November 21, 2013
Last updated November 21, 2013
Start date January 2007

Study information
Verified date January 2007
Source Xiangya Hospital of Central South University
Contact n/a
Is FDA regulated No
Health authority Ethics Committee: China
Study type Observational

Clinical Trial Summary

We hypothesis a period of early NCPAP before surfactant treatment is effective for treating RDS and preventing BPD in very premature infants.

Recruitment information / eligibility
Status Completed
Enrollment 683
Est. completion date
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group N/A to 2 Hours
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Xiangya Hospital of Central South University

Outcome
Type Measure Description Time frame Safety issue
Primary death or bronchopulmonary dysplasia 24 hours after birth Yes
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