Continued Pressure for Alveolar Protection (CPAP Trial)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
NICHD Neonatal Research Network
Study ID
NCT07417111
Status
Recruiting
Apply to this trial

Conditions

  • Bronchopulmonary Dysplasia (BPD)

Eligibility Criteria

Sex
ALL
Age
N/A - 31 Weeks
Healthy Volunteers
Not accepted

Interventions

  • CPAP — DEVICE
    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 — DEVICE
    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 Details

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.

Key Dates

First listed
Feb 18, 2026
Start date
Nov 5, 2026
Status verified
Jul 2026
Primary completion
Nov 5, 2028
Completion
Jan 30, 2029

Study Design

Enrollment
860 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Waldemar A Carlo, MD
Waldemar A Carlo, MD (PRINCIPAL_INVESTIGATOR)
Stanford UniversityPalo AltoCalifornia94304
Valerie Chock, MD
Valerie Chock, MD (PRINCIPAL_INVESTIGATOR)
Sharp Mary Birch Hospital for Women & NewbornsSan DiegoCalifornia92123
Anup Katheria, MD
Anup Katheria, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30303
Ravi Patel, MD
Ravi Patel, MD (PRINCIPAL_INVESTIGATOR)
Northwestern Lurie Children's Hospital of ChicagoChicagoIllinois60611
Aaron Hamvas, MD
Aaron Hamvas, MD (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Tarah Colaizy, MD
Tarah Colaizy, MD (PRINCIPAL_INVESTIGATOR)
University of Mississippi Medical Center - Children's of MississippiJacksonMississippi39216
Abhay Bhatt, MD
Abhay Bhatt, MD (PRINCIPAL_INVESTIGATOR)
University of New MexicoAlbuquerqueNew Mexico87131
Janell Fuller, MD
Janell Fuller, MD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27710
Michael Cotton, MD
Michael Cotton, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Medical CenterCincinnatiOhio45267
Stephanie Merhar, MD MS
Stephanie Merhar, MD MS (PRINCIPAL_INVESTIGATOR)
Case Western Reserve University, Rainbow Babies and Children's HospitalClevelandOhio44106
Anna M Hibbs, MD
Anna M Hibbs, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Sara DeMauro, MD
Sara DeMauro, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical Center at DallasDallasTexas75235
Myra Wyckoff, MD
Myra Wyckoff, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at HoustonHoustonTexas77030
Matthew Rysavy, MD
Matthew Rysavy, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84108
Robin Ohls, MD
Robin Ohls, MD (PRINCIPAL_INVESTIGATOR)

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University of Alabama at Birmingham· Birmingham, ALStanford University· Palo Alto, CASharp Mary Birch Hospital for Women & Newborns· San Diego, CAEmory University· Atlanta, GANorthwestern Lurie Children's Hospital of Chicago· Chicago, ILUniversity of Iowa· Iowa City, IA

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