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Baby breathing treatment: gene test may end guesswork for albuterol in bronchiolitis

NCT ID NCT06946264

Knowledge-focused Sponsor: Nemours Children's Clinic 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a common asthma drug, albuterol, helps babies with bronchiolitis (a lung infection). Researchers will give 400 children either albuterol or a placebo and check their breathing. They will also collect DNA samples to see if certain genes predict who gets better. The goal is to create a tool that helps doctors decide when to use this treatment.

What this could mean

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

Active substance
Albuterol (a bronchodilator drug given as a mist)
What this could lead to
If successful, this could lead to a simple test to predict which children with bronchiolitis will benefit from albuterol, reducing unnecessary treatments and improving care.
What could go wrong
This is an early-stage study focused on finding genetic markers, not proving a cure. The results may not lead to immediate changes in treatment, and the genetic links may be weak or not generalizable.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

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

Started

Jul 2022

Expected to finish

Dec 2030

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

3 to 24 months

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: * Children between 3 to 24 months of age * Clinical diagnosis of bronchiolitis by the treating provider(s), defined by the American Academy of Pediatrics as a clinical syndrome involving lower respiratory tract symptoms * Children who either have no history of prematurity or have a history of prematurity but without associated co-morbidities * Emergency department (ED) visit to seek care at Nemours Children's Health-Florida (NCH-FL) Exclusion Criteria: * Patients previously enrolled in the PI's K12 study * Documented history of asthma or reactive airway disease * Co-morbidities affecting airway response (e.g., chronic lung disease, bronchopulmonary dysplasia, bronchiectasis, congenital heart disease, immunodeficiency, neurologic condition) * Diagnosis of pneumonia by chest radiography * Inhaled, nebulized, or oral corticosteroid use within 72 hours of ED evaluation * Inhaled, nebulized, or oral bronchodilator administration within 4 hours of ED arrival

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Conditions

The condition(s) this trial relates to.

bronchiolitis

As listed by the trial registrant

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

Bronchiolitis Bronchodilator agents

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

  • Nemours Children's Health

    RECRUITING

    Orlando, Florida, 32827, United States

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