NCT07418502

Pressure Targeting During High Flow Therapy in Premature Infants

A Phase 2 Crossover Trial of Pressure Targeted High Flow Therapy in Premature Infants

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 7 Days – 40 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Preterm Infants
• Respiratory Distress Syndrome (Neonatal)
• BPD - Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
PROCEDURE	Pressure Targeted High Flow	High Flow Nasal Cannula therapy with Pressure monitoring to match delivered CPAP pressure
PROCEDURE	CPAP	Standard of care CPAP therapy

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-08-01
• Completion: 2027-09-01
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

2 sites across 1 country: United States