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Continued Pressure for Alveolar Protection (CPAP Trial)
Sponsor: NICHD Neonatal Research Network
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.
Official title: Continued Pressure for Alveolar Protection: A Randomized Controlled Trial (CPAP Trial)
Key Details
Gender
All
Age Range
Any - 31 Weeks
Study Type
INTERVENTIONAL
Enrollment
860
Start Date
2026-11-05
Completion Date
2029-01-30
Last Updated
2026-07-14
Healthy Volunteers
No
Conditions
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.
Locations (15)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States
Emory University
Atlanta, Georgia, United States
Northwestern Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Mississippi Medical Center - Children's of Mississippi
Jackson, Mississippi, United States
University of New Mexico
Albuquerque, New Mexico, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States