Continuing CPAP protection for extremely preterm babies to reduce BPD or death

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial compares two breathing support strategies in extremely preterm infants who are on CPAP. Participants must be born before 29 weeks and be on CPAP with stable oxygen needs, then be randomized to either extend CPAP until 34 weeks' PMA or extend for at least two weeks before transitioning to nasal cannula. The primary goal is to see if the longer CPAP approach reduces bronchopulmonary dysplasia or death by 36 weeks' PMA. Key safety and stability criteria are required for enrollment, and several sites in California and Alabama will participate under NICHD leadership. The study builds on prior neonatal respiratory-support research to optimize outcomes for the smallest and most vulnerable patients.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Stanford University
  Palo Alto, California, United States Recruiting
• Sharp Mary Birch Hospital for Women & Newborns
  San Diego, California, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Northwestern Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting
• University of Iowa
  Iowa City, Iowa, United States Recruiting

Study contacts

• Principal investigator: Colm P. Travers, MD — University of Alabama at Birmingham
• Study coordinator: Colm P. Travers, MD
• Email: cptravers@uabmc.edu
• Phone: 205-934-3100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.