Pressure Targeting During High Flow Therapy in Premature Infants

Part of paid clinical trials in San Diego, California.

Sponsor
University of Texas at Austin
Study ID
NCT07418502
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
7 Days - 40 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Pressure Targeted High Flow — PROCEDURE
    High Flow Nasal Cannula therapy with Pressure monitoring to match delivered CPAP pressure
  • CPAP — PROCEDURE
    Standard of care CPAP therapy

Study Details

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 Dates

Start date
May 1, 2026
Status verified
Feb 2026
Primary completion
Aug 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Other: PTHF First
    PTHF prior to CPAP
  • Other: CPAP First
    CPAP prior to PTHF

Primary Outcome Measure

Failure of Support [ Time Frame: 24 hours ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Sharp Mary Birch Hospital for Women & NewbornsSan DiegoCalifornia92123
Anup Katheria
[email protected]
858-939-3400
Ascension Seton Medical CenterAustinTexas78705
Alan Groves
[email protected]
512 324 1085

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By research site
Sharp Mary Birch Hospital for Women & Newborns· San Diego, CAAscension Seton Medical Center· Austin, TX

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