Continued Pressure for Alveolar Protection (CPAP Trial)
Continued Pressure for Alveolar Protection: A Randomized Controlled Trial (CPAP Trial)
NICHD Neonatal Research Network
860 participants
Nov 5, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- Gestational age <29 weeks at birth
- PMA <32 weeks at study entry
- On treatment with CPAP without a rate in FiO2 <0.25 and PEEP of 4-5 cmH2O
- Meet stability criteria:
- If previously intubated must be extubated ≥ 72 hours
- <3 self-resolving apneas (≤ 20 s) and/or bradycardia (<100 bpm) in any hour over previous 6 hours
- No episodes of apnea or bradycardia requiring intervention (oxygen/stimulation/bag and mask) for 24 hours
- Parents/legal guardians consent for enrollment
Exclusion Criteria7
- Major malformation
- Neuromuscular condition that affects respiration
- Terminal illness
- Decision to withhold or limit support
- Too sick to participate in opinion of Attending physician
- Clinical shock, sepsis
- Planned surgery during study period
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Interventions
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.
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)
View Full Details on ClinicalTrials.gov
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NCT07417111