Preterm InfantsPhase 2NeoMATCHNCT07418502
Pressure Targeting During High Flow Therapy in Premature Infants
A Phase 2 study testing Pressure Targeted High Flow and CPAP in people with Preterm Infants and Respiratory Distress Syndrome (Neonatal), run by University of Texas at Austin at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 days to 40 weeks
- Conditions the study is for
- Preterm Infants, Respiratory Distress Syndrome (Neonatal), BPD - Bronchopulmonary Dysplasia
- What is being tested?
- Pressure Targeted High Flow and CPAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2026to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 40 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Ascension Seton Medical Center
Austin, Texas, 78705
Alan Groves, 512 324 1085, alan.groves@austin.utexas.edu
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123
Anup Katheria, 858-939-3400, anup.katheria@sharp.com
About this study
Official title: 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.
- Conditions
- Preterm Infants, Respiratory Distress Syndrome (Neonatal), BPD - Bronchopulmonary Dysplasia
- Being tested
- Pressure Targeted High Flow, CPAP
- Keywords
- preterm, CPAP, High Flow
- Medical subject headings
- Pulmonary Atelectasis, Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure Targeted High FlowProcedure or surgery
High Flow Nasal Cannula therapy with Pressure monitoring to match delivered CPAP pressure
CPAPProcedure or surgery
Standard of care CPAP therapy
| Study group | Role | What they receive |
|---|---|---|
| PTHF First | Other | PTHF prior to CPAP Receives: Procedure: Pressure Targeted High Flow |
| CPAP First | Other | CPAP prior to PTHF Receives: Procedure: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (5)
Oxygenation
ratio of mean SpO2 to FiO2
Measured: 24 hours
Respiratory Rate
Mean respiratory rate
Measured: 24 hours
Infant comfort - NIPE
Newborn Infant Parasympathetic Evaluation
Measured: 24 hours
Infant Comfort - Parent
Parental Questionnaire
Measured: 24 hours
Resource Use
Number of handling/repositioning episodes by nurse/respiratory therapist
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 May 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Sharp Mary Birch Hospital for Women & Newborns
- Responsible party
- Principal investigator, Alan Groves, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418502
- Sponsor's protocol ID
- FP00010928
- Acronym
- NeoMATCH
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Happy to share IPD if a need arises
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Crossover Trial of Pressure Targeted High Flow Therapy in Premature Infants
- ClinicalTrials.gov ID
- NCT07418502
- Acronym / sponsor ID
- NeoMATCH / FP00010928
- Conditions
- Preterm Infants, Respiratory Distress Syndrome (Neonatal), BPD - Bronchopulmonary Dysplasia
- Keywords
- preterm, CPAP, High Flow
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Sharp Mary Birch Hospital for Women & Newborns
- Study start
- 1 May 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTHF First | Other | Procedure: Pressure Targeted High FlowPTHF prior to CPAP |
| CPAP First | Other | Procedure: CPAPCPAP prior to PTHF |
Who may qualify
- Ages
- 7 days to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure Targeted High FlowHigh Flow Nasal Cannula therapy with Pressure monitoring to match delivered CPAP pressure | Procedure or surgery | PTHF First |
| CPAPStandard of care CPAP therapy | Procedure or surgery | CPAP First |
Primary outcome
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
5 secondary outcomes
Oxygenation
Time frame: 24 hours
Respiratory Rate
Time frame: 24 hours
Infant comfort - NIPE
Time frame: 24 hours
Infant Comfort - Parent
Time frame: 24 hours
Resource Use
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: Undecided. Happy to share IPD if a need arises
Related trials for Preterm Infants
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pressure Targeted High Flow and CPAP in people with Preterm Infants and Respiratory Distress Syndrome (Neonatal), run by University of Texas at Austin at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alan Groves (512 324 1085, alan.groves@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of Support (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.