Pressure Targeted High Flow for Premature Birth

(NeoMATCH Trial)

Not yet recruiting at 1 trial location

Overseen By Alan Groves

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Texas at Austin

Disqualifiers: Chromosomal disorder, Congenital defects, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I weigh at least 1,000 grams.

Delivery at >24+0 weeks and ≤32+6 weeks of gestation

I use a CPAP machine set between 5 and 8 cm H2O pressure.

Exclusion Criteria

Presence of major congenital birth defect including airway anomalies, congenital diaphragmatic hernia or cardiac defects (other than patent foramen ovale and patent ductus arteriosus)

I have had a collapsed lung before.

Infants in whom chance of survival is uncertain

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 24 hours of Pressure Targeted High Flow and 24 hours of CPAP, with monitoring of breathing rate, oxygen requirement, and comfort markers

48 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CPAP
• Pressure Targeted High Flow

How Is the Trial Designed?

Group I: PTHF First Experimental Treatment 1 Intervention

PTHF prior to CPAP

Group II: CPAP First Experimental Treatment 1 Intervention

CPAP prior to PTHF

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Sharp Mary Birch Hospital for Women & Newborns

Collaborator

Trials

13

Recruited

6,600+