NCT01996670

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
683

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
Last Updated

November 27, 2013

Status Verified

January 1, 2007

Enrollment Period

5.9 years

First QC Date

November 21, 2013

Last Update Submit

November 21, 2013

Conditions

Nasal Continuous Positive Airway Pressure,Preterm Infants,Surfactant Treatment,Respiratory Distress Syndrome,Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

  • death or bronchopulmonary dysplasia

    24 hours after birth

Study Arms (3)

<2h group

2-4h group

>4h group

Eligibility Criteria

Age30 Minutes - 2 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Distress SyndromeBronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersVentilator-Induced Lung InjuryLung InjuryInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Neonatology

Study Record Dates

First Submitted

November 21, 2013

First Posted

November 27, 2013

Study Start

January 1, 2007

Primary Completion

December 1, 2012

Last Updated

November 27, 2013

Record last verified: 2007-01