Pressure Targeting During High Flow Therapy in Premature Infants

Starting soon · Phase 2

Conditions studied: Preterm Infants, Respiratory Distress Syndrome (Neonatal), BPD - Bronchopulmonary Dysplasia

In brief

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.

Key facts

Study ID

NCT07418502

Run by

University of Texas at Austin

People needed

78

Starts

2026-05-01

Expected to finish

2027-09-01

Last updated by the study team

2026-02-18

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sharp Mary Birch Hospital for Women & Newborns — San Diego, California, United States
• Ascension Seton Medical Center — Austin, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.