Pressure Targeting During High Flow Therapy in Premature Infants (NeoMATCH)

February 10, 2026 updated by: Alan Groves, University of Texas at Austin

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • Sharp Mary Birch Hospital for Women & Newborns
        • Contact:
    • Texas
      • Austin, Texas, United States, 78705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PTHF First
PTHF prior to CPAP
Procedure: Pressure Targeted High Flow
High Flow Nasal Cannula therapy with Pressure monitoring to match delivered CPAP pressure
Other: CPAP First
CPAP prior to PTHF
Procedure: CPAP
Standard of care CPAP therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure of Support
Time Frame: 24 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation
Time Frame: 24 hours
ratio of mean SpO2 to FiO2
24 hours
Respiratory Rate
Time Frame: 24 hours
Mean respiratory rate
24 hours
Infant comfort - NIPE
Time Frame: 24 hours
Newborn Infant Parasympathetic Evaluation
24 hours
Infant Comfort - Parent
Time Frame: 24 hours
Parental Questionnaire
24 hours
Resource Use
Time Frame: 24 hours
Number of handling/repositioning episodes by nurse/respiratory therapist
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

Sharp Mary Birch Hospital for Women & Newborns

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FP00010928

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Happy to share IPD if a need arises

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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