Pressure Targeting During High Flow Therapy in Premature Infants
NeoMATCH
A Phase 2 Crossover Trial of Pressure Targeted High Flow Therapy in Premature Infants
1 other identifier
interventional
78
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2026
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2026
CompletedFirst Posted
Study publicly available on registry
February 18, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
February 18, 2026
February 1, 2026
1.3 years
February 10, 2026
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Failure of Support
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
24 hours
Secondary Outcomes (5)
Oxygenation
24 hours
Respiratory Rate
24 hours
Infant comfort - NIPE
24 hours
Infant Comfort - Parent
24 hours
Resource Use
24 hours
Study Arms (2)
PTHF First
OTHERPTHF prior to CPAP
CPAP First
OTHERCPAP prior to PTHF
Interventions
High Flow Nasal Cannula therapy with Pressure monitoring to match delivered CPAP pressure
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123, United States
Ascension Seton Medical Center
Austin, Texas, 78705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
February 10, 2026
First Posted
February 18, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
February 18, 2026
Record last verified: 2026-02