Recruiting

CPAP

Sponsor:

NICHD Neonatal Research Network

Code:

NCT07417111

Conditions

Bronchopulmonary Dysplasia (BPD)

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

CPAP

Nasal Cannula

Study Details

Brief summary:

The objective of the CPAP Trial is to test whether extending CPAP until 34 weeks' PMA or for at least 2 additional weeks compared to weaning to a nasal canula will decrease the likelihood of bronchopulmonary dysplasia or death at 36 weeks' PMA.

Conditions

Bronchopulmonary Dysplasia (BPD)

Study ID

NCT07417111

Start date

Nov 5, 2026

Status verified date

Jul, 2026

Completion date

Jan 30, 2029

Anticipated

Primary completion date

Nov 5, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Gestational age <29 weeks at birth
  • PMA <32 weeks at study entry
  • On treatment with CPAP without a rate in FiO2 <0.25 and PEEP of 4-5 cmH2O
  • Meet stability criteria:
  • If previously intubated must be extubated ≥ 72 hours
  • <3 self-resolving apneas (≤ 20 s) and/or bradycardia (<100 bpm) in any hour over previous 6 hours
  • No episodes of apnea or bradycardia requiring intervention (oxygen/stimulation/bag and mask) for 24 hours
  • Parents/legal guardians consent for enrollment

Exclusion Criteria:

  • Major malformation
  • Neuromuscular condition that affects respiration
  • Terminal illness
  • Decision to withhold or limit support
  • Too sick to participate in opinion of Attending physician
  • Clinical shock, sepsis
  • Planned surgery during study period

Study Design

Enrollment

860 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Continuous Positive Airway Pressure

CPAP will be provided via mask or binasal prongs to maintain a relatively uniform CPAP delivery system among infants in the treatment group. Bubble CPAP will be preferred over other modes of CPAP delivery whenever available.

active comparator: Nasal Cannula

HFNC at 4 L/min will be used initially in the control group. Flow should be titrated down by 1 L/min per day until ≤0.5 L/kg among infants in the nasal cannula group if not meeting pre-specified failure criteria to reduce the risk of inadvertent positive end-expiratory pressure (PEEP). Flow can also be increased (up to 6 L/min maximum) if needed among infants on NC who meet the pre-specified failure criteria. Infants in the control group placed back on CPAP may use an interface at provider discretion.

Interventions

CPAP

Prior to study entry, the CPAP interface (includes RAM cannula, Optiflow, large bore cannulas, mask, prongs) and mode (bubble, variable-flow, ventilator-derived) used is at the discretion of the provider and center. After study entry, CPAP will be provided via mask or binasal prongs to maintain a relatively uniform CPAP delivery system among infants in the treatment group. Bubble CPAP will be preferred over other modes of CPAP delivery whenever available.

Nasal Cannula

HFNC at 4 L/min will be used initially in the control group. Flow should be titrated down by 1 L/min per day until ≤0.5 L/kg among infants in the nasal cannula group if not meeting pre-specified failure criteria to reduce the risk of inadvertent positive end-expiratory pressure (PEEP). Flow can also be increased (up to 6 L/min maximum) if needed among infants on NC who meet the pre-specified failure criteria. Infants in the control group placed back on CPAP may use an interface at provider discretion.

Primary outcome measure

  • Bronchopulmonary Dysplasia or Death [ Time Frame: 36 Weeks' PMA ]

Central Contacts and Locations

Central contacts

Colm P. Travers, MD

205-934-3100cptravers@uabmc.edu

Abhik Das, PhD

301-230-4640adas@rti.org

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Principal Investigator:

Waldemar A Carlo, MD

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Principal Investigator:

Valerie Chock, MD

Sharp Mary Birch Hospital for Women & Newborns

Recruiting

San Diego, California, United States, 92123

Principal Investigator:

Anup Katheria, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30303

Principal Investigator:

Ravi Patel, MD

Northwestern Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Aaron Hamvas, MD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Principal Investigator:

Tarah Colaizy, MD

University of Mississippi Medical Center - Children's of Mississippi

Recruiting

Jackson, Mississippi, United States, 39216

Principal Investigator:

Abhay Bhatt, MD

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131

Principal Investigator:

Janell Fuller, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator:

Michael Cotton, MD

Cincinnati Children's Medical Center

Recruiting

Cincinnati, Ohio, United States, 45267

Principal Investigator:

Stephanie Merhar, MD MS

Case Western Reserve University, Rainbow Babies and Children's Hospital

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Anna M Hibbs, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Sara DeMauro, MD

University of Texas Southwestern Medical Center at Dallas

Recruiting

Dallas, Texas, United States, 75235

Principal Investigator:

Myra Wyckoff, MD

University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Matthew Rysavy, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Principal Investigator:

Robin Ohls, MD

More Information

Sponsor

NICHD Neonatal Research Network

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • Continuous Positive Airway Pressure
  • CPAP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by NICHD Neonatal Research Network on 2026-07-14.