[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583433":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":71,"collaborators":75,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":21,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":43,"whyStopped":21,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AI App + Standard of care clinical exam","EXPERIMENTAL","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.",[13,14],"Diagnostic Test: Standard Clinical Ear Exam","Diagnostic Test: AI app ear exam and diagnosis",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"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.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"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",[9],[27],{"name":28,"affiliation":29,"role":30},"Timothy R Shope, MD, MPH","UPMC Children's Hospital","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":21,"email":35},"CONTACT","412-692-5471","timothy.shope@chp.edu",{"name":37,"role":33,"phone":38,"phoneExt":21,"email":39},"Nader Shaikh, MD, MPH","412-996-2653","nader.shaikh@chp.edu",[41,60],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Children's Community Pediatrics Brentwood","RECRUITING","Pittsburgh","Pennsylvania","15227","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-79.99589,40.44062,{"lat":53,"lon":52},[56],{"name":57,"role":33,"phone":58,"phoneExt":21,"email":59},"Patrick Tate, MD","412-443-7980","patrick.tate1@chp.edu",{"facility":61,"status":43,"city":44,"state":45,"zip":62,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Children's Community Pediatrics Castle Shannon","15234",{"type":50,"coordinates":64},[52,53],{"lat":53,"lon":52},[67],{"name":68,"role":33,"phone":69,"phoneExt":21,"email":70},"Marc Yester, MD","336-251-8024","yesterma@upmc.edu",{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"SPONSOR_INVESTIGATOR","Timothy Shope","Professor of Pediatrics",[76],{"name":77,"class":78},"Merck Sharp & Dohme LLC","INDUSTRY","100583433","artificial-intelligence-diagnostic-decision-support-to-reduce-antimicrobial-prescriptions-in-young-children-with-colds-100583433",false,"NCT06876259","Artificial Intelligence Diagnostic Decision Support to Reduce Antimicrobial Prescriptions in Young Children With Colds","Intelligent Medical Assessment for Guiding Ear Infection Treatment","IMAGE","Inclusion Criteria:\n\n* Age 6-24 months\n* Presence of upper respiratory infection\n\nExclusion Criteria:\n\n* No upper respiratory infection\n* Otorrhea\n* Tympanostomy tubes\n* Currently taking antimicrobials","ALL","6 Months","24 Months",{"count":91,"type":92},300,"ESTIMATED","INTERVENTIONAL",[95],"NA","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.",[98,99],"Acute Otitis Media (AOM)","Upper Respiratory Infection",[101,102,103,104,105],"acute otitis media","diagnosis","artificial intelligence","diagnostic classifier","antimicrobial stewardship","2026-01-06",{"date":108,"type":109},"2026-01-07","ACTUAL",{"date":111,"type":109},"2025-12-04",{"date":113,"type":92},"2027-07-01",{"name":73,"class":6},2]