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

NCT06876259 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-01-07

No results posted yet for this study

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.

Conditions

  • Acute Otitis Media (AOM)
  • Upper Respiratory Infection

Interventions

DIAGNOSTIC_TEST

Standard 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_TEST

AI 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

Sponsors & Collaborators

Principal Investigators

  • Timothy R Shope, MD, MPH · UPMC Children's Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-04
Primary Completion
2026-12-30
Completion
2027-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06876259 on ClinicalTrials.gov