Artificial Intelligence Diagnostic Decision Support to Reduce Antimicrobial Prescriptions in Young Children With Colds

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Timothy Shope
Study ID
NCT06876259
Status
Recruiting
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Conditions

  • Acute Otitis Media (AOM)
  • Upper Respiratory Infection

Eligibility Criteria

Sex
ALL
Age
6 Months - 24 Months
Healthy Volunteers
Not accepted

Interventions

  • Standard Clinical Ear Exam — DIAGNOSTIC_TEST
    The clinician will examine the child's ear with a standard otoscope and give a clinical diagnosis and decision to treat with antibiotics.
  • AI app ear exam and diagnosis — DIAGNOSTIC_TEST
    Using a standard otoscope with a cell phone mounted to it, research personnel will record a video image of the tympanic membrane and send it to the cloud for analysis using AI enhanced classification software to render a diagnosis and treatment recommendation

Study Details

Ear infections are common in young children with cold symptoms, but they can be difficult to diagnose due to small ear canals, child movement, and limited viewing time. In this study, investigators will take photos of the eardrums of children 6-24 months of age with upper respiratory symptoms. The photos will be reviewed by imaging software enhanced with artificial intelligence (AI app) to determine whether the AI app changes how ear infections are diagnosed and treated. The AI app has undergone rigorous study and was found to be highly accurate; but how using this technology affects the diagnosis and treatment by clinicians has not been studied. This research may help improve diagnostic accuracy for ear infections and ensure antibiotics are prescribed only for those children who have definite ear infections.

Key Dates

Start date
Dec 4, 2025
Status verified
Sep 2025
Primary completion
Dec 30, 2026
Completion
Jul 1, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: AI App + Standard of care clinical exam
    Using a within subject design, each child's ear will be in the experimental and standard care group. Each ear will be examined by the AI app and a clinician (blinded to the AI app diagnosis) to provide a diagnosis and treatment recommendation.

Primary Outcome Measure

Antimicrobial prescription rate [ Time Frame: Day 1 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Community Pediatrics BrentwoodPittsburghPennsylvania15227
Patrick Tate, MD
[email protected]
412-443-7980
Children's Community Pediatrics Castle ShannonPittsburghPennsylvania15234
Marc Yester, MD
[email protected]
336-251-8024

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