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New breathing method could ease preemie lung care

NCT ID NCT07418502

Disease control Sponsor: University of Texas at Austin Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a new breathing support called Pressure Targeted High Flow works as well as standard CPAP in premature infants with breathing problems. About 78 babies born before 33 weeks will try each method for 24 hours. Researchers will monitor breathing, oxygen needs, and comfort to see if the new approach is a good alternative.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pressure Targeted High Flow (a breathing support procedure)
What this could lead to
If it works, this could offer a more comfortable breathing support option for premature infants that is easier for staff to manage.
What could go wrong
This is a small, early-phase trial with only 78 infants, so results may not apply to all preemies. The new method might not provide enough support, leading to breathing failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

7 days to 40 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bronchopulmonary dysplasia Premature Birth Pulmonary Atelectasis respiratory distress syndrome in premature infants

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BPD - bronchopulmonary dysplasia Preterm infants Respiratory distress syndrome (neonatal)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ascension Seton Medical Center

    Austin, Texas, 78705, United States

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, California, 92123, United States

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