Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07417111

Continued Pressure for Alveolar Protection (CPAP Trial)

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Bronchopulmonary Dysplasia (BPD) Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

Up to 31 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Bronchopulmonary Dysplasia or Death

    Time frame: 36 Weeks' PMA

    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).

Secondary outcomes

  1. Days alive and off respiratory support

    Time frame: 34-40 weeks' PMA

    The number of days alive and off respiratory support from 34 weeks' to 40 weeks' PMA

  2. Mortality at 36 Weeks

    Time frame: 36 Weeks' PMA

    Mortality

  3. Death or Grade 2-3 BPD

    Time frame: 36 Weeks' PMA

    Mortality at 36 weeks' PMA or grade 3 BPD

  4. Death or Grade 3 BPD

    Time frame: 36 Weeks' PMA

    Mortality or grade 3 BPD

  5. Retinopathy of prematurity

    Time frame: 52 weeks' PMA

    Retinopathy of prematurity ≥ stage 3 or requiring treatment (laser/anti-VEGF)

  6. Respiratory support, supplemental oxygen, and pulmonary medications

    Time frame: 40 weeks' PMA

    Use of supplemental oxygen, respiratory support (including low-flow nasal cannula), and pulmonary medications (methylxanthines, steroids, diuretics, albuterol) at discharge and 40 weeks' PMA

  7. Full PO feedings

    Time frame: 52 weeks' PMA

    PMA at first full PO feeding (where full PO feeding is defined as intake of 120 mL/kg/day by mouth, even if an NG tube remains in situ)

  8. Length of hospitalization

    Time frame: 52 Weeks' PMA

    Length of hospitalization from 34 weeks' PMA

Other outcomes

  1. Post-prematurity respiratory disease at two years follow up

    Time frame: 22-26 months

    Post-prematurity respiratory disease (PPRD) or death at 22-26 months follow-up.

  2. Pulmonary medications and respiratory support at two years follow up

    Time frame: 22-26 months

    Pulmonary medications (inhaled or oral steroids, bronchodilators, diuretics, and vasodilators), history of rehospitalizations for respiratory reasons, pulmonary clinic visits, respiratory support (including oxygen, CPAP, or ventilation), bronchoscopy, and respiratory-related surgeries such as tracheal surgeries, repairs, and dilatations; and wheezing or diagnosis of asthma using a modified ISAAC questionnaire at 22-26 months follow-up.

  3. Long-term mortality

    Time frame: 22-26 months

    Mortality at 22-28 month follow up

  4. Nasal/skin injury

    Time frame: 36 Weeks' PMA

    Presence of nasal/skin injury during study intervention period

  5. Nebulized epinephrine to treat Stridor

    Time frame: 36 Weeks' PMA

    Nebulized epinephrine for stridor during intervention period

  6. Tracheomalacia

    Time frame: 52 Weeks' PMA

    Tracheomalacia diagnosed by bronchoscopy before discharge

  7. Intubation, chest compressions/epinephrine

    Time frame: 36 Weeks' PMA

    Intubation and/or chest compressions/epinephrine during study intervention period

  8. Pneumothorax

    Time frame: 36 Weeks' PMA

    Pneumothorax during study intervention period

Study contacts

Contact information is provided by the study sponsor or research team.

Abhik Das, PhD

CONTACT

[email protected]

301-230-4640

Colm P. Travers, MD

CONTACT

[email protected]

205-934-3100

Sponsors and collaborators

Lead sponsor

NICHD Neonatal Research Network

Network

Collaborators

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

Registry information

Official study title

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

Acronym: CPAP

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 18, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.