Continued Pressure for Alveolar Protection (CPAP Trial) (CPAP)

July 13, 2026 updated by: NICHD Neonatal Research Network

Continued Pressure for Alveolar Protection: A Randomized Controlled Trial (CPAP Trial)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
860

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Abhik Das, PhD
  • Phone Number: 301-230-4640
  • Email: adas@rti.org

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
          • Waldemar A Carlo, MD
        • Principal Investigator:
          • Waldemar A Carlo, MD
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Valerie Chock, MD
        • Contact:
          • Valerie Chock, MD
      • San Diego, California, United States, 92123
        • Recruiting
        • Sharp Mary Birch Hospital for Women & Newborns
        • Contact:
          • Anup Katheria, MD
        • Principal Investigator:
          • Anup Katheria, MD
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Emory University
        • Contact:
          • Ravi Patel, MD
        • Principal Investigator:
          • Ravi Patel, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Lurie Children's Hospital of Chicago
        • Contact:
          • Aaron Hamvas, MD
        • Principal Investigator:
          • Aaron Hamvas, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Principal Investigator:
          • Tarah Colaizy, MD
        • Contact:
          • Tarah Colaizy, MD
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center - Children's of Mississippi
        • Principal Investigator:
          • Abhay Bhatt, MD
        • Contact:
          • Abhay Bhatt, MD
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Recruiting
        • University of New Mexico
        • Principal Investigator:
          • Janell Fuller, MD
        • Contact:
          • Janell Fuller, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Contact:
          • Michael Cotton, MD
        • Principal Investigator:
          • Michael Cotton, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • Cincinnati Children's Medical Center
        • Contact:
          • Stephanie Merhar, MD MS
        • Principal Investigator:
          • Stephanie Merhar, MD MS
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Case Western Reserve University, Rainbow Babies and Children's Hospital
        • Contact:
          • Anna M Hibbs, MD
        • Principal Investigator:
          • Anna M Hibbs, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Contact:
          • Sara DeMauro, MD
        • Principal Investigator:
          • Sara DeMauro, MD
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • University Of Texas Southwestern Medical Center At Dallas
        • Contact:
          • Myra Wyckoff, MD
        • Principal Investigator:
          • Myra Wyckoff, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas Health Science Center at Houston
        • Principal Investigator:
          • Matthew Rysavy, MD
        • Contact:
          • Matthew Rysavy, MD
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah
        • Contact:
          • Robin Ohls, MD
        • Principal Investigator:
          • Robin Ohls, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: 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.
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bronchopulmonary Dysplasia or Death
Time Frame: 36 Weeks' PMA
The likelihood of BPD or death at 36 weeks' Postmenstrual Age (PMA): a five-level ordinal outcome (death, survival with grade 3 BPD, survival with grade 2 BPD, survival with grade 1 BPD, and survival free of any BPD).
36 Weeks' PMA

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Days alive and off respiratory support
Time Frame: 34-40 weeks' PMA
The number of days alive and off respiratory support from 34 weeks' to 40 weeks' PMA
34-40 weeks' PMA
Mortality at 36 Weeks
Time Frame: 36 Weeks' PMA
Mortality
36 Weeks' PMA
Death or Grade 2-3 BPD
Time Frame: 36 Weeks' PMA
Mortality at 36 weeks' PMA or grade 3 BPD
36 Weeks' PMA
Death or Grade 3 BPD
Time Frame: 36 Weeks' PMA
Mortality or grade 3 BPD
36 Weeks' PMA
Retinopathy of prematurity
Time Frame: 52 weeks' PMA
Retinopathy of prematurity ≥ stage 3 or requiring treatment (laser/anti-VEGF)
52 weeks' PMA
Respiratory support, supplemental oxygen, and pulmonary medications
Time Frame: 40 weeks' PMA
Use of supplemental oxygen, respiratory support (including low-flow nasal cannula), and pulmonary medications (methylxanthines, steroids, diuretics, albuterol) at discharge and 40 weeks' PMA
40 weeks' PMA
Full PO feedings
Time Frame: 52 weeks' PMA
PMA at first full PO feeding (where full PO feeding is defined as intake of 120 mL/kg/day by mouth, even if an NG tube remains in situ)
52 weeks' PMA
Length of hospitalization
Time Frame: 52 Weeks' PMA
Length of hospitalization from 34 weeks' PMA
52 Weeks' PMA

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post-prematurity respiratory disease at two years follow up
Time Frame: 22-26 months
Post-prematurity respiratory disease (PPRD) or death at 22-26 months follow-up.
22-26 months
Pulmonary medications and respiratory support at two years follow up
Time Frame: 22-26 months
Pulmonary medications (inhaled or oral steroids, bronchodilators, diuretics, and vasodilators), history of rehospitalizations for respiratory reasons, pulmonary clinic visits, respiratory support (including oxygen, CPAP, or ventilation), bronchoscopy, and respiratory-related surgeries such as tracheal surgeries, repairs, and dilatations; and wheezing or diagnosis of asthma using a modified ISAAC questionnaire at 22-26 months follow-up.
22-26 months
Long-term mortality
Time Frame: 22-26 months
Mortality at 22-28 month follow up
22-26 months
Nasal/skin injury
Time Frame: 36 Weeks' PMA
Presence of nasal/skin injury during study intervention period
36 Weeks' PMA
Nebulized epinephrine to treat Stridor
Time Frame: 36 Weeks' PMA
Nebulized epinephrine for stridor during intervention period
36 Weeks' PMA
Tracheomalacia
Time Frame: 52 Weeks' PMA
Tracheomalacia diagnosed by bronchoscopy before discharge
52 Weeks' PMA
Intubation, chest compressions/epinephrine
Time Frame: 36 Weeks' PMA
Intubation and/or chest compressions/epinephrine during study intervention period
36 Weeks' PMA
Pneumothorax
Time Frame: 36 Weeks' PMA
Pneumothorax during study intervention period
36 Weeks' PMA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NICHD Neonatal Research Network

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Colm P. Travers, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 5, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NICHD-NRN-0067
  • 1U01HD115553-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. The NRN plans to share de-identified data after final publication in an NIH supported data repository such as the NICHD Data and Specimen Hub (https://dash.nichd.nih.gov).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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