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Bronchopulmonary Dysplasia (BPD)CPAPNCT07417111

Continued Pressure for Alveolar Protection (CPAP Trial)

A study testing CPAP and Nasal Cannula in people with Bronchopulmonary Dysplasia (BPD), run by NICHD Neonatal Research Network at 15 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages Up to 31 weeks
Conditions the study is for
Bronchopulmonary Dysplasia (BPD)
What is being tested?
CPAP and Nasal Cannula
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
860 participants
Where
15 sitesUnited States
Study dates
5 Nov 2026to 30 Jan 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 31 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Colm P. Travers, MD contact

205-934-3100

cptravers@uabmc.edu

Abhik Das, PhD contact

301-230-4640

adas@rti.org

15 sites in 1 country

United States15 sites, 15 recruiting

  • University of New Mexico

    Albuquerque, New Mexico, 87131

    Janell Fuller, MD

    Janell Fuller, MD

    Recruiting

  • Emory University

    Atlanta, Georgia, 30303

    Ravi Patel, MD

    Ravi Patel, MD

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Waldemar A Carlo, MD

    Waldemar A Carlo, MD

    Recruiting

  • Northwestern Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

    Aaron Hamvas, MD

    Aaron Hamvas, MD

    Recruiting

  • Cincinnati Children's Medical Center

    Cincinnati, Ohio, 45267

    Stephanie Merhar, MD MS

    Stephanie Merhar, MD MS

    Recruiting

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

    Cleveland, Ohio, 44106

    Anna M Hibbs, MD

    Anna M Hibbs, MD

    Recruiting

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75235

    Myra Wyckoff, MD

    Myra Wyckoff, MD

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Michael Cotton, MD

    Michael Cotton, MD

    Recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Matthew Rysavy, MD

    Matthew Rysavy, MD

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Tarah Colaizy, MD

    Tarah Colaizy, MD

    Recruiting

  • University of Mississippi Medical Center - Children's of Mississippi

    Jackson, Mississippi, 39216

    Abhay Bhatt, MD

    Abhay Bhatt, MD

    Recruiting

  • Stanford University

    Palo Alto, California, 94304

    Valerie Chock, MD

    Valerie Chock, MD

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Sara DeMauro, MD

    Sara DeMauro, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84108

    Robin Ohls, MD

    Robin Ohls, MD

    Recruiting

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, California, 92123

    Anup Katheria, MD

    Anup Katheria, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
CPAP, Nasal Cannula
Keywords
Continuous Positive Airway Pressure, CPAP
Medical subject headings
Bronchopulmonary Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPAPDevice

    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 CannulaDevice

    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.

Study groups in NCT07417111
Study groupRoleWhat they receive
Continuous Positive Airway PressureExperimentalCPAP 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.
Receives: Device: CPAP
Nasal CannulaActive comparatorHFNC 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.
Receives: Device: Nasal Cannula

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bronchopulmonary Dysplasia or Death

    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).

    Measured: 36 Weeks' PMA

Secondary outcomes (8)

  1. Days alive and off respiratory support

    The number of days alive and off respiratory support from 34 weeks' to 40 weeks' PMA

    Measured: 34-40 weeks' PMA

  2. Mortality at 36 Weeks

    Mortality

    Measured: 36 Weeks' PMA

  3. Death or Grade 2-3 BPD

    Mortality at 36 weeks' PMA or grade 3 BPD

    Measured: 36 Weeks' PMA

  4. Death or Grade 3 BPD

    Mortality or grade 3 BPD

    Measured: 36 Weeks' PMA

  5. Retinopathy of prematurity

    Retinopathy of prematurity ≥ stage 3 or requiring treatment (laser/anti-VEGF)

    Measured: 52 weeks' PMA

  6. Respiratory support, supplemental oxygen, and pulmonary medications

    Use of supplemental oxygen, respiratory support (including low-flow nasal cannula), and pulmonary medications (methylxanthines, steroids, diuretics, albuterol) at discharge and 40 weeks' PMA

    Measured: 40 weeks' PMA

  7. Full PO feedings

    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)

    Measured: 52 weeks' PMA

  8. Length of hospitalization

    Length of hospitalization from 34 weeks' PMA

    Measured: 52 Weeks' PMA

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2026
  2. Study start5 Nov 2026 (estimated)
  3. Primary completion5 Nov 2028 (estimated)
  4. Study completion30 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This will be a randomized controlled trial with a 1:1 parallel allocation of infants to Continuous Positive Airway Pressure (CPAP) or Nasal Cannula (NC) using stratified permuted block design. Randomization will be stratified by gestational age (≥ 22 0/7 weeks to ≤ 24 6/7 weeks, ≥ 25 0/7 weeks to ≤ 26 6/7, and ≥ 27 0/7 to ≤ 28 6/7).
Masking
None (open label)
Enrolment
860 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07417111
Sponsor's protocol ID
NICHD-NRN-0067
Other IDs
1U01HD115553-01A1
Acronym
CPAP
Status last verified
Jul 2026
First submitted
16 Jan 2026
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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).

Questions about this trial

What is this clinical trial studying?

A study testing CPAP and Nasal Cannula in people with Bronchopulmonary Dysplasia (BPD), run by NICHD Neonatal Research Network at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Colm P. Travers, MD (205-934-3100, cptravers@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bronchopulmonary Dysplasia or Death (time frame: 36 Weeks' PMA). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07417111.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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