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New 'Ultrasound for the Ear' could slash unnecessary antibiotics in kids

NCT ID NCT05353569

Diagnosis Sponsor: Medical College of Wisconsin 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a new imaging technology called optical coherence tomography (OCT) can help doctors more accurately diagnose ear infections in children. Researchers will compare standard ear exams with OCT-enhanced exams in 235 children. The goal is to see if OCT reduces unnecessary antibiotic prescriptions or surgeries for middle ear problems.

What this could mean

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

Active substance
OCT device (optical coherence tomography)
What this could lead to
If successful, OCT could become a standard tool to more accurately diagnose ear infections in children, reducing unnecessary antibiotic prescriptions and surgeries.
What could go wrong
This is an early-stage diagnostic study, not a treatment trial. The device may not prove significantly better than current methods, 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.

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 235 people

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

Started

May 2022

Expected to finish

Apr 2028

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

12 months to 6 years

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: * Parental complaint of ear infection or ear pain (Children's Wisconsin Urgent Care Clinics) OR referred for evaluation of otitis media with effusion (Children's Wisconsin ENT Clinic) * Speak English Exclusion Criteria: * Children with craniofacial abnormalities * Children with diagnosed immunologic abnormalities * Children with congenital syndromic conditions * Current open and functioning ear tubes

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Conditions

The condition(s) this trial relates to.

infectious otitis media otitis media otitis media with effusion

As listed by the trial registrant

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

Otitis media Otitis media acute Otitis media with effusion

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

  • Children's Wisconsin ENT Clinic

    RECRUITING

    Wauwatosa, Wisconsin, 53226, United States

  • Children's Wisconsin Urgent Care Clinics

    RECRUITING

    Wauwatosa, Wisconsin, 53226, United States

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