Pressure Targeting During High Flow Therapy in Premature Infants
This study is looking at two ways to help premature infants with breathing problems: 'Pressure Targeted High Flow' and 'CPAP' (Continuous Positive Airway Pressure), which is the usual care. We want to see if Pressure Targeted High Flow works as well as CPAP for these babies. We will also learn about how comfortable the babies are with each treatment and how it affects hospital staff. The study aims to find out if Pressure Targeted High Flow provides enough support for premature infants. To join, your baby must be between 7 days and 6 weeks old, weigh at least 1,000 grams, and be receiving CPAP. The study is currently unclear on its recruitment status and plans to enroll 78 infants. Success will be measured by whether the breathing support fails within 24 hours.
- Study design
- This study is interventional and plans to enroll 78 participants. It compares two different breathing support methods.
- What's involved
- Participants will spend 24 hours supported by Pressure Targeted High Flow and 24 hours supported by CPAP. During this time, their breathing rate, oxygen needs, and comfort will be watched.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures failure of support at 24 hours. No further follow-up is specified.
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Pressure Targeting During High Flow Therapy in Premature Infants
At a glance
Conditions
NCT07418502
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Ascension Seton Medical Center
Austin, Texasstudy coordinator listed
Sharp Mary Birch Hospital for Women & Newborns
San Diego, Californiastudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
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Inclusion
Exclusion
What this trial measures
- Failure of Support24 hours
Failure of respiratory support as defined by increase in fraction of inspired oxygen (FiO2) of ≥0.10, a pH of ≤7.2 with a CO2 ≥60 mm Hg, an increase in transcutaneous CO2 of ≥15mmHg above baseline or ≥2 episodes of apnea requiring positive-pressure ventilation