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

NCT05204719 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-01

No results posted yet for this study

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 Preterm Newborn Infants Born by Cesarean Delivery, Compared to No Early Prophylactic Continuous Positive Airway Pressure with or without Supplemental Oxygen, on the Need for Further Respiratory Support Leading to NICU Admissions.

Conditions

  • Premature Birth

Interventions

PROCEDURE

Prophylactic Delivery Room Continuous Positive Airway Pressure

Prophylactic Delivery Room Continuous Positive Airway Pressure (DR-CPAP) of 5-6 cm H20 will be provided for 20 minutes through the face mask or the appropriate size of nasal prong after the initial steps as per the participating institution's neonatal resuscitation protocol.

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    collaborator OTHER

  • Columbia University

    collaborator OTHER

  • St. Louis University

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • Indiana University

    collaborator OTHER

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Birju A Shah, MD · Univeristy of Oklahoma Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
5 Minutes
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-04
Primary Completion
2025-01-23
Completion
2027-05-31

Countries

  • United States
  • Canada
  • Chile

Study Locations

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Entities

Companies

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 NCT05204719 on ClinicalTrials.gov