Status:

ACTIVE_NOT_RECRUITING

Prophylactic DR-CPAP on Late Preterm Infants Born by C-section: an RCT

Lead Sponsor:

University of Oklahoma

Collaborating Sponsors:

Pontificia Universidad Catolica de Chile

Columbia University

Conditions:

Premature Birth

Eligibility:

All Genders

1-5 years

Phase:

NA

Brief Summary

A Pragmatic Randomized Controlled Pilot Trial to Evaluate the Impact of Early Prophylactic Continuous Positive Airway Pressure with or without Supplemental Oxygen in Spontaneously Breathing Late Prete...

Detailed Description

A prospective multicenter randomized controlled trial of prophylactic delivery room continuous positive airway pressure (DR-CPAP) versus no prophylactic DR-CPAP will be conducted. Neonates with an obs...

Eligibility Criteria

Inclusion

  • Inborn newborns delivered by Cesarean section, gestational age between 34 weeks and \< 37 weeks.

Exclusion

  • Major congenital anomalies including pulmonary hypoplasia and lethal life-limiting conditions.

Key Trial Info

Start Date :

August 4 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2025

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT05204719

Start Date

August 4 2023

End Date

December 1 2025

Last Update

October 17 2025

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Indiana University

Indianapolis, Indiana, United States, 46202

2

Saint Louis University

St Louis, Missouri, United States, 63104

3

The University of Oklahoma Health Campus

Oklahoma City, Oklahoma, United States, 73104

4

University of Alberta

Edmonton, Alberta, Canada, T5H 3V9