RecruitingNot ApplicableNCT06876259

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

Intelligent Medical Assessment for Guiding Ear Infection Treatment


Sponsor

Timothy Shope

Enrollment

300 participants

Start Date

Dec 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 6 MonthsMax Age: 24 Months

Inclusion Criteria2

  • Age 6-24 months
  • Presence of upper respiratory infection

Exclusion Criteria4

  • No upper respiratory infection
  • Otorrhea
  • Tympanostomy tubes
  • Currently taking antimicrobials

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Interventions

DIAGNOSTIC_TESTStandard Clinical Ear Exam

The clinician will examine the child's ear with a standard otoscope and give a clinical diagnosis and decision to treat with antibiotics.

DIAGNOSTIC_TESTAI app ear exam and diagnosis

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


Locations(2)

Children's Community Pediatrics Brentwood

Pittsburgh, Pennsylvania, United States

Children's Community Pediatrics Castle Shannon

Pittsburgh, Pennsylvania, United States

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NCT06876259


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