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NCT Number: NCT07418502

Pressure Targeting During 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.

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Key information

Conditions

Preterm Infants BPD - Bronchopulmonary Dysplasia Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Pulmonary Atelectasis Respiratory Distress Syndrome (Neonatal) Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

7 day–40 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sharp Mary Birch Hospital for Women & Newborns, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Oxygenation

    Time frame: 24 hours

    ratio of mean SpO2 to FiO2

  2. Respiratory Rate

    Time frame: 24 hours

    Mean respiratory rate

  3. Infant comfort - NIPE

    Time frame: 24 hours

    Newborn Infant Parasympathetic Evaluation

  4. Infant Comfort - Parent

    Time frame: 24 hours

    Parental Questionnaire

  5. Resource Use

    Time frame: 24 hours

    Number of handling/repositioning episodes by nurse/respiratory therapist

Study contacts

Contact information is provided by the study sponsor or research team.

Alan Groves

CONTACT

[email protected]

512 324 1085

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • Sharp Mary Birch Hospital for Women & Newborns

Registry information

Official study title

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

Acronym: NeoMATCH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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