Pressure Targeting During High Flow Therapy in Premature... | NCT07418502

Studies
Pressure Targeting During High Flow Therapy in Premature Infants

NCT07418502

Sponsor

University of Texas at Austin

Status

Not yet recruiting

Last Update Posted

Feb 18, 2026Actual

Enrollment

78Estimated

Phase

Phase 2

Conditions

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

Interventions

Pressure Targeted High Flow
CPAP

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2026Estimated

Primary Completion Date

Aug 2027Estimated

Completion Date

Sep 2027Estimated

First Submitted Date

Feb 10, 2026

First Submission Date that Met QC Criteria

Feb 10, 2026

First Posted Date

Feb 18, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2026

Last Update Posted Date

Feb 18, 2026Actual

Name	Class
Sharp Mary Birch Hospital for Women & Newborns	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PTHF First	Other	PTHF prior to CPAP	Procedure: Pressure Targeted High Flow
CPAP First	Other	CPAP prior to PTHF	Procedure: CPAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pressure Targeted High Flow	Procedure	High Flow Nasal Cannula therapy with Pressure monitoring to match delivered CPAP pressure	PTHF First

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Oxygenation	ratio of mean SpO2 to FiO2	24 hours
Respiratory Rate	Mean respiratory rate	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Days

Maximum Age

40 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alan Groves	Contact	512 324 1085		alan.groves@austin.utexas.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sharp Mary Birch Hospital for Women & Newborns		San Diego	California	92123	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Happy to share IPD if a need arises

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001261	Pulmonary Atelectasis
D001997	Bronchopulmonary Dysplasia
D047928	Premature Birth

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D055397	Ventilator-Induced Lung Injury
D055370	Lung Injury

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Browse Branches

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