AI-guided eardrum photos to improve diagnosis of ear infections in infants
Official title: Intelligent Medical Assessment for Guiding Ear Infection Treatment
Run by University of Pittsburgh · NCT06876259 · Data updated 2026-11-12
This will test an AI app that reads photos of infants' eardrums to see if it changes how doctors diagnose ear infections and prescribe antibiotics for children 6–24 months with cold symptoms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Months to 24 Months |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 2 sites (Pittsburgh, Pennsylvania and 1 other locations) |
| Status | Recruiting |
| Started | December 4, 2025 |
| Main results expected | March 30, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT06876259 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6–24 months with upper respiratory symptoms who are not currently taking antibiotics and who do not have tympanostomy tubes or purulent ear drainage are ideal candidates.
✕Probably not a fit
Children with ear tubes, visible purulent ear drainage, no upper respiratory symptoms, or those already on antimicrobials would not be eligible and are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a 12-month, single-center, within-subject trial enrolling about 300 children aged 6–24 months who present with upper respiratory symptoms. Each child's ears will be photographed and reviewed both by a standard clinical exam and by an AI imaging app in a double-blind within-subject design, producing paired diagnoses. The primary outcome compares antimicrobial prescription rates using 150 paired image/clinician decisions, and secondary outcomes include the proportion of uninterpretable images and AOM diagnosis rates. Parents will record symptoms daily for 10 days in electronic diaries to track symptom resolution and side effects, with study staff contacting families if symptom scores rise by more than 20%.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary antibiotic prescriptions by improving diagnostic accuracy for ear infections in young children.
How similar studies have gone: Prior technical studies of AI eardrum classifiers have shown high diagnostic accuracy, but using such apps to change clinician prescribing in routine care remains largely untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 6-24 months * Presence of upper respiratory infection Exclusion Criteria: * No upper respiratory infection * Otorrhea * Tympanostomy tubes * Currently taking antimicrobials
Where it's running
-
Children's Community Pediatrics Brentwood
Pittsburgh, Pennsylvania, United States Recruiting -
Children's Community Pediatrics Castle Shannon
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Timothy R Shope, MD, MPH — UPMC Children's Hospital
- Study coordinator: Timothy R Shope, MD, MPH
- Email: timothy.shope@chp.edu
- Phone: 412-692-5471
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.