Not Yet RecruitingPhase 2

Pressure Targeting During High Flow Therapy in Premature Infants

United States78 participantsStarted 2026-05-01

Plain-language summary

The goal of this study is to see if a new approach to breathing support ('Pressure Targeted High Flow') is as effective as standard of care ('Continuous Positive Airway Pressure') in prematurely born infants. It will also learn about the effect of these types of breathing support on infant comfort and impact on staffing. The main question it aims to answer is: Does Pressure Targeted High Flow provide enough support in premature infants? Participants will: Take spend 24 hours supported by Pressure Targeted High Flow and 24 hours supported by CPAP. During this time their breathing rate, oxygen requirement and other markers of comfort will be monitored.

Who can participate

Age range7 Days – 40 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Delivery at \>24+0 weeks and ≤32+6 weeks of gestation * Postnatal age \>7 days but \< 6 weeks old * Weight ≥1,000grams at the time of study * Receiving clinically prescribed CPAP at pressures of 5-8cm H2O * Requiring an FiO2 of ≤0.60 Exclusion Criteria: * Chromosomal disorder (aneuploidy) * Presence of major congenital birth defect including airway anomalies, congenital diaphragmatic hernia or cardiac defects (other than patent foramen ovale and patent ductus arteriosus) * Prior pneumothorax * Infants in whom chance of survival is uncertain

What they're measuring

Failure of Support

Timeframe: 24 hours

Trial details

NCT IDNCT07418502

SponsorUniversity of Texas at Austin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Alan Groves

512 324 1085 alan.groves@austin.utexas.edu

View on ClinicalTrials.gov More Preterm Infants trials