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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
2026-05-31
Completion Date
2029-01-30
Last Updated
2026-02-18
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.