Continued Pressure for Alveolar Protection (CPAP Trial)

NCT07417111 | Not Yet Recruiting DMC

• 2 other identifiers: NICHD-NRN-00671U01HD115553-01A1
• Study Type: interventional
• Target: 860
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

Continuous Positive Airway Pressure; CPAP

Outcome Measures

Primary Outcomes (1)

• Bronchopulmonary Dysplasia or Death

  The likelihood of BPD or death at 36 weeks' Postmenstrual Age (PMA): a five-level ordinal outcome (death, survival with grade 3 BPD, survival with grade 2 BPD, survival with grade 1 BPD, and survival free of any BPD).

  36 Weeks' PMA

Secondary Outcomes (8)

• Days alive and off respiratory support

  34-40 weeks' PMA

• Mortality at 36 Weeks

  36 Weeks' PMA

• Death or Grade 2-3 BPD

  36 Weeks' PMA

• Death or Grade 3 BPD

  36 Weeks' PMA

• Retinopathy of prematurity

  52 weeks' PMA

Other Outcomes (8)

• Post-prematurity respiratory disease at two years follow up

  22-26 months

• Pulmonary medications and respiratory support at two years follow up

  22-26 months

• Long-term mortality

  22-26 months

Study Arms (2)

Continuous Positive Airway Pressure

EXPERIMENTAL

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: CPAP

Nasal Cannula

ACTIVE COMPARATOR

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.

Device: Nasal Cannula

Interventions

CPAP DEVICE

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.

Continuous Positive Airway Pressure

Nasal Cannula DEVICE

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.

Nasal Cannula

Eligibility Criteria

• Age: Up to 31 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NICHD Neonatal Research Network: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

Cannula

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The inherent nature of ventilator/respiratory support interventions often precludes the ability to blind investigators and caregivers. As such, many studies in this domain face the limitation of not being blinded. The study team recognizes this limitation and will implement measures to mitigate potential biases arising from an unblinded trial. The DCC PI who will be overseeing the statistical team will be masked. Additionally, interim analysis (efficacy and safety) reports presented to the Data and Safety Monitoring Board (DSMB) will be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This will be a randomized controlled trial with a 1:1 parallel allocation of infants to Continuous Positive Airway Pressure (CPAP) or Nasal Cannula (NC) using stratified permuted block design. Randomization will be stratified by gestational age (≥ 22 0/7 weeks to ≤ 24 6/7 weeks, ≥ 25 0/7 weeks to ≤ 26 6/7, and ≥ 27 0/7 to ≤ 28 6/7).

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 18, 2026
• Study Start (Estimated): November 5, 2026
• Primary Completion (Estimated): November 5, 2028
• Study Completion (Estimated): January 30, 2029
• Last Updated: June 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share