Intelligent Medical Assessment for Guiding Ear Infection Treatment

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 2
Healthy Volunteers: f
View:

• Age 6-24 months

• Presence of upper respiratory infection

Locations
United States
Pennsylvania
Children's Community Pediatrics Brentwood
RECRUITING
Pittsburgh
Children's Community Pediatrics Castle Shannon
RECRUITING
Pittsburgh
Contact Information
Primary
Timothy R Shope, MD, MPH
timothy.shope@chp.edu
412-692-5471
Backup
Nader Shaikh, MD, MPH
nader.shaikh@chp.edu
412-996-2653
Time Frame
Start Date: 2025-12-04
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 300
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Timothy Shope

This content was sourced from clinicaltrials.gov