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Continued Pressure for Alveolar Protection (CPAP Trial)

NCT07417111 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 860

Last updated 2026-02-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • NICHD Neonatal Research Network

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
31 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-11-05
Completion
2029-01-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07417111 on ClinicalTrials.gov