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Tiny lungs, big Tune-Up: can adjusting ventilator pressure help preterm babies?

NCT ID NCT06512935

Knowledge-focused Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how changing the pressure on a ventilator affects the lungs and heart of very premature babies (born before 34 weeks). Researchers will try different pressure levels and use ultrasound and imaging to see which setting works best for breathing and blood flow. The goal is to find a way to personalize ventilator care for these fragile infants.

What this could mean

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

Active substance
ventilator pressure adjustment (PEEP changes)
What this could lead to
If successful, this could help doctors set ventilators more precisely for preterm babies, potentially improving breathing and heart function.
What could go wrong
This is a very small, early study (24 infants) focused on measuring responses, not on long-term outcomes. Results may not apply to all preterm infants.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 24 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 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 to 30 days

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: Preterm infants with recovering respiratory distress syndrome (RDS) who were born at a gestational age \< 34 weeks and are receiving respiratory support via conventional mechanical ventilation or on HFJV. * Post-natal age \> 7 days and less than 1 month (outside golden week protocol) * Gestational age ≥ 21 weeks and ≤ 34 week * Infants with written informed consent obtained from legal guardian Exclusion Criteria: * Blood culture-positive sepsis * Congenital anomalies affecting respiration * Cyanotic or ductal-dependent congenital heart disease * Newborns who are considered too unstable for study enrolment per neonatology attending * Newborns on pressors or steroids for maintaining cardiac output * Non-invasive ventilation or newborn with significant BPD (bronchopulmonary dysplasia) with pulmonary hypertension (HTN) * Open skin wounds or abrasions on the chest wall.

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Conditions

The condition(s) this trial relates to.

adult acute respiratory distress syndrome bronchopulmonary dysplasia Hypoxia pulmonary hypertension owing to lung disease and/or hypoxia respiratory distress syndrome in premature infants

As listed by the trial registrant

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

Bronchopulmonary dysplasia Extreme prematurity Pulmonary hypertension due to lung diseases and hypoxia Ventilation perfusion mismatch Ventilator lung; newborn

How to take part

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

  1. The places running it

    1 site. 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

  • Univerisity of Alabama

    RECRUITING

    Birmingham, Alabama, 35233, United States

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