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Watching Asthma's early steps in toddlers

NCT ID NCT05210361

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 192 toddlers aged 18 to 36 months who are at high risk for asthma due to wheezing episodes. Researchers track their health over time to understand how asthma develops in early childhood. The goal is to find better ways to prevent and treat asthma in the future.

What this could mean

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

What this could lead to
If successful, this research could help doctors identify early signs of asthma and develop better ways to prevent or treat it in young children.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to immediate changes in care, and results may not apply to all children.

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.

Participants

192 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Jul 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.

Who is studied

The study population will consist of toddlers at high risk for developing childhood asthma, living in low-income urban communities in the Denver Metropolitan Area in Colorado.

Ages

18 to 36 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: * Age 18 months to 36 months at first research encounter * For enrollment in Emergency Department (ED)/Inpatient Visit: Presentation to the ED/Inpatient with an acute wheezing episode AND either evidence of at least one prior wheezing episode documented in the electronic medical record (i.e., wheezing, pneumonitis, bronchiolitis, reactive airways disease, or asthma) that occurred ≥ 14 days from current episode, or caregiver report of one of the following: * Child has had wheezing or whistling in the chest at any time in the past lasting at least 24 hours and occurring at least 14 days prior to the current ED visit * Child has been treated with albuterol or used an inhaler or a nebulizer at least 14 days prior to the current ED visit * Caregiver has been told that their child has bronchiolitis, asthma, or reactive airways disease at least 14 days prior to the current ED visit * For enrollment in Visit 1: At least three separate wheezing episodes, separated by at least 14 consecutive days without a wheezing episode (wheezing lasting ≥ 24 hours), as reported by parent/caregiver or patient's care provider and/or documented in the patient's medical record * Third episode may be at time of presentation to ED or admission as inpatient (IP) to hospital when recruitment would occur (Visit ED/IP) * Bronchiolitis and wheezing/asthma exacerbations are considered wheezing episodes * The wheezing episode does not require treatment with bronchodilators * Live within a US Office of Management and Budget-defined Metropolitan Statistical Area (MSA) and meet at least one of these criteria: 1. Have publicly funded health insurance AND/OR 2. Live in a census tract within an MSA where ≥10% of families have income below the poverty level Exclusion Criteria: * Wheeze attributed to alternative diagnoses other than bronchiolitis or asthma, including congenital anatomical abnormalities, foreign body aspiration, chronic lung disease of prematurity, other chronic lung disorders such as cystic fibrosis, and cardiac, immune, and gastrointestinal disorders. * Gestational age \< 32 weeks.

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Conditions

The condition(s) this trial relates to.

childhood onset asthma Respiratory Sounds

As listed by the trial registrant

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

Contacts and locations

Locations

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

More trials for these conditions

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