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New combo therapy aims to prevent lung damage in tiniest preemies

NCT ID NCT06855043

Disease control Sponsor: University of Wisconsin, Madison 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving a special lung medicine (surfactant mixed with budesonide) to extremely premature babies who are still on a breathing machine at 7-14 days old is safe and can help prevent a serious lung condition called bronchopulmonary dysplasia. About 24 babies will take part. The goal is to see if this late treatment improves breathing and reduces lung injury.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 24 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

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 14 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.

Neonate Inclusion Criteria: * Gestational age 22 0/7 to 28 6/7 weeks at birth * Age 7-14 days * Need invasive mechanical ventilatory support and a Fraction of Inspired Oxygen (FiO2) greater than or equal to 0.3 Birthing Parent Inclusion Criteria: * Have a baby who meets neonate eligibility criteria and enrolls in the study. Neonate Exclusion Criteria: * Major congenital anomalies including congenital lung malformations and congenital diaphragmatic hernia and/or genetic disorders * Alternative, acute clinical etiology of respiratory deterioration or increased ventilatory requirements (e.g., sepsis, pneumonia, etc.) * History of pulmonary hemorrhage * Antibiotic use within 48 hours * Indomethacin or Ibuprofen use within 72 hours * Prior treatment with corticosteroids for prevention of lung disease * Not expected to survive for greater than 7 days at enrollment * Determined to be unstable by the clinical team * Enrolled in a conflicting clinical trial * Have a birth parent aged less than 18 years * Parent/guardian is unable to provide parental permission in English or Spanish

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome Premature Birth respiratory distress syndrome in premature infants bronchopulmonary dysplasia prevention target

As listed by the trial registrant

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

Invasive mechanical ventilation Severe respiratory distress syndrome

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

  • American Family Children's Hospital

    Madison, Wisconsin, 53792, United States

  • Meriter Hospital

    Madison, Wisconsin, 53715, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.