NCT05204719

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 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.

Trial Health

78
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
3 countries

5 active sites

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Aug 2023May 2027

First Submitted

Initial submission to the registry

November 23, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 4, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2025

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

November 23, 2021

Last Update Submit

March 26, 2026

Conditions

Premature Birth

Keywords

Neonatal ResuscitationClinical TrialLate Preterm InfantsLung AerationRespiratory Transition

Outcome Measures

Primary Outcomes (2)

  • Effectiveness

    Duration of respiratory support including supplemental oxygen

    up to 30 days or hospital discharge

  • Adverse outcomes

    Proportion of air leaks and any other safety related adverse outcomes

    first 24 hours after birth

Study Arms (2)

Prophylactic Delivery Room Continuous Positive Airway Pressure

EXPERIMENTAL

If the infant is spontaneously breathing and allocated to the experimental arm, s/he will receive 20 min of 5 cm H2O of prophylactic continuous airway pressure using either a face mask or the appropriate size of nasal prong.

Procedure: Prophylactic Delivery Room Continuous Positive Airway Pressure

No Prophylactic Delivery Room Continuous Positive Airway Pressure

NO INTERVENTION

Alternatively, spontaneously breathing infants assigned to control group will receive the standard of care with no prophylactic delivery room continuous positive airway pressure (CPAP). In both groups, CPAP can be used to help babies with persistent labored breathing or cyanosis after the initial steps as per the participating institution's neonatal resuscitation protocol. At any time, if the patient does not present spontaneous breathing, an escalation on the resuscitation measures will be performed and the study intervention will be terminated.

Interventions

Prophylactic Delivery Room Continuous Positive Airway PressurePROCEDURE

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.

Also known as: DR-CPAP
Prophylactic Delivery Room Continuous Positive Airway Pressure

Eligibility Criteria

Age1 Minute - 5 Minutes
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

The University of Oklahoma Health Campus

Oklahoma City, Oklahoma, 73104, United States

Location

University of Alberta

Edmonton, Alberta, T5H 3V9, Canada

Location

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, 8331150, Chile

Location

Related Publications (1)

  • Shah BA, Fabres JG, Leone TA, Schmolzer GM, Szyld EG; International Liaison Committee on Resuscitation Neonatal Life Support Task Force. Continuous positive airway pressure for term and >/=34+0 weeks' gestation newborns at birth: A systematic review. Resusc Plus. 2022 Nov 8;12:100320. doi: 10.1016/j.resplu.2022.100320. eCollection 2022 Dec.

    PMID: 36386766BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Birju A Shah, MD

    Univeristy of Oklahoma Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2021

First Posted

January 24, 2022

Study Start

August 4, 2023

Primary Completion

January 23, 2025

Study Completion (Estimated)

May 1, 2027

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)US(3)CA(1)