NCT07417111

Continued Pressure for Alveolar Protection (CPAP Trial)

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 860 (estimated)
• Sponsor: NICHD Neonatal Research Network · Network
• Sex: All
• Age: 31 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchopulmonary Dysplasia (BPD)

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-05-31
• Primary completion: 2028-11-05
• Completion: 2029-01-30
• First posted: 2026-02-18
• Last updated: 2026-02-18