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

The University of Texas System (UT)

Status and phase: Not yet enrolling; Phase 2

Conditions: Preterm Infants; BPD - Bronchopulmonary Dysplasia; Respiratory Distress Syndrome (Neonatal)

Treatments: Procedure: Pressure Targeted High Flow; Procedure: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT07418502

FP00010928

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 7 days to 40 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

PTHF First

Other group

Description:

PTHF prior to CPAP

Treatment:

Procedure: Pressure Targeted High Flow

CPAP First

Other group

Description:

CPAP prior to PTHF

Treatment:

Procedure: CPAP