[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-otitis-media\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-otitis-media":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,80,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100643164","parent-led-assessment-and-recognition-of-aom-using-digital-ear-imaging-100643164",false,"NCT07640568","Parent-led Assessment and Recognition of AOM Using Digital Ear Imaging","PARENT-EAR","Inclusion Criteria:\n\n* At least one episode of AOM within the last 12 months\n* Family speaks fluent Finnish\n\nExclusion Criteria:\n\n* Tympanostomy tubes or perforation of the TM, or scheduled for upcoming tympanostomy\n* Middle ear fluid at the time of recruitment\n* Previously diagnosed hearing loss\n* Immunosuppressive disorder or medication, excluding inhaled corticosteroids\n* Anatomic defect or anomaly affecting the susceptibility to AOM\n* Previous otoscopy experience of the participating parent",true,"ALL","12 Months","47 Months",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"NA","Acute otitis media (AOM) is the most common bacterial infection in young children and a major contributor to healthcare utilization and costs. Diagnosis relies on otoscopy and identification of tympanic membrane (TM) bulging, yet physician-performed otoscopy has variable diagnostic accuracy and depends heavily on clinical expertise.\n\nDigital otoscopy combined with artificial intelligence (AI)-based image analysis has demonstrated high diagnostic accuracy in previous studies. In a recent study by our group, digital otoscopy with an automated neural network classifier reliably ruled out otitis media in children.\n\nThe PARENT-EAR randomized controlled pilot trial aims to evaluate whether parent-performed digital otoscopy at home, combined with retrospective AI analysis of captured TM images, can reduce physician visits due to suspicion of AOM. The study also assesses feasibility, diagnostic accuracy of parents after training, and potential effects on antibiotic use and healthcare utilization.\n\nMethods and outcomes The PARENT-EAR trial is a randomized controlled pilot trial conducted at Vaasa Central Hospital and Turku University Hospital. Recruitment will occur between September and December 2026 (extended if necessary), with follow-up ending May 31, 2027 (5-9 months per participant).\n\nChildren aged 12 to 47 months with at least one AOM episode in the past 12 months will be randomized 1:1 using permuted block randomization. Exclusion criteria include tympanostomy tubes, tympanic membrane perforation, middle ear effusion at recruitment, immunosuppression, previously diagnosed hearing loss or anatomical abnormalities predisposing to AOM, and otoscopy experience of the parent.\n\nIntervention group:\n\nParents receive a digital otoscope (The Ear Penguin by Sibbo Medical Devices, MDR EU Class I device) and training on TM image interpretation. They complete a TM image classification quiz before and after the training. During follow-up, parents perform home otoscopy when suspecting AOM, capture TM images\u002Fvideos, interpret findings, and record symptoms in a diary. If AOM is suspected or the child appears ill, medical evaluation is instructed.\n\nControl group:\n\nStandard care without home otoscopy. Parents complete the same symptom diary and seek care according to usual practice.\n\nStatistical analyses will compare outcomes between groups. AI-based TM classification will be compared against expert panel evaluation.\n\nThis is a pilot study with a target sample size of 20 children per arm, limited by device availability.\n\nEthical aspects, data collection and handling The study will be conducted in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all parents after provision of oral and written information. Participation is voluntary, and families may withdraw at any time. Investigators may discontinue participation if deemed in the child's best interest.\n\nThe digital otoscope is a CE-marked Class I medical device used solely for visual inspection of the tympanic membrane. Pneumatic pumps are not provided. Potential risks include minor ear canal abrasions or discomfort; serious adverse events are considered rare. Any adverse events will be managed according to standard clinical practice and reported to relevant authorities when required. The study is investigator-initiated. The device manufacturer provides the otoscopes but has no role in study design, data access, or analysis.\n\nData will be collected via paper symptom diaries, monthly REDCap questionnaires (University of Turku), and national electronic health records (Kanta). TM images and videos will be securely stored and imported into a research database with relevant metadata.\n\nAll data will be handled in accordance with the EU General Data Protection Regulation (GDPR 2016\u002F679). Study data will be pseudonymized and identified only by study ID numbers. The key linking personal identifiers to study IDs will be stored separately and securely. Paper diaries will be destroyed after digitalization. Consent includes permission to access health records and to use collected images and data for scientific purposes. Results will be published in peer-reviewed journals and as part of a doctoral thesis.",[28,29],"Acute Otitis Media","Otitis Media",[31,32,33,34],"acute otitis media","otitis media","digital otoscopy","telemedicine","NOT_YET_RECRUITING","2026-06-06",{"date":38,"type":39},"2026-06-10","ACTUAL",{"date":41,"type":22},"2026-09-01",{"date":43,"type":22},"2027-08-31",{"name":45,"class":46},"Turku University Hospital","OTHER_GOV",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100518710","interventions-to-de-implement-unnecessary-antibiotic-prescribing-for-children-with-ear-infections-100518710","NCT06034080","Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections","DISAPEAR Trial: Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections","DISAPEAR","Inclusion Criteria:\n\nA. Implementation of Interventions 1. Clinic at a participating organization 2. Provides care to children with AOM 3. Administrative or local approval for participation\n\nB. Secondary Electronic Health Record Data\n\n1. Aged 6 months-17-years-old (inclusive)\n2. Diagnosis of AOM by ICD10 code\n\nC. Video recordings or direct observation of the use of a shared decision aid\n\nParent participation:\n\n1. Child aged 6 months-17 years (inclusive)\n2. Diagnosed with AOM by clinician\n3. Parent or legal guardian is present and is \\>=18 years or older\n\nClinician Participation:\n\n1. Licensed clinician and not a medical trainee\n2. Age 18 \\>= years or older\n\nD. Pre-implementation interviews of clinicians and administrators\n\n1. Licensed clinician (physician or advanced practice clinician) that cares for children with AOM at a participating organization or an administrator\u002Fmanager at a participating organization.\n2. Aged \\>=18 years-no maximum\n\nE. Pre-implementation focus groups of parents\n\n1. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization.\n2. 18 years of age or older and able\u002Fwilling to consent\n\nF. Parents enrolled for surveys\n\n1\\. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization. 2. Willing to participate and able to complete electronic surveys at enrollment and 10 days after enrollment. 3. Working phone 4. Age \\>=18 years of age\n\nG. Post-intervention focus groups of parents\n\n1. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization.\n2. 18 years of age or older and able\u002Fwilling to consent\n\nH. Post-intervention surveys of clinicians and administrators\n\n1. Licensed clinician (physician or advanced practice clinician) that cares for children with AOM at a participating organization or an administrator\u002Fmanager at a participating organization.\n2. Aged \\>=18 years-no maximum\n\nExclusion Criteria:\n\nA. Implementation of Interventions\n\n1\\. Clinics that exclusively provide telehealth\n\nB. Secondary Electronic Health Record Data\n\n1\\. None\n\nC. Video recordings or direct observation of the use of a shared decision aid\n\nParent participation:\n\n1\\. None\n\nClinician Participation:\n\n1\\. None\n\nD. Pre-implementation interviews of clinicians and administrators 1. Medical trainee (student, resident, fellow, etc.)\n\nE. Pre-implementation focus groups of parents\n\n1\\. None\n\nF. Parents enrolled for surveys 1. Complicated or recurrent AOM as determined by the study team\n\nG. Post-intervention focus groups of parents 1. None\n\nH. Post-intervention surveys of clinicians and administrators\n\n1\\. Medical trainee (student, resident, fellow, etc.)","6 Months","17 Years",{"count":59,"type":22},1566,[25],"This study aims to improve care and reduce unnecessary antibiotic prescribing for children with ear infections. The study will compare the effectiveness of a \"gold standard\" to a hybrid intervention combined with this gold standard, in order to identify steps to increase parent satisfaction for child ear infection care. The \"gold standard\" approach is a Health System Level Intervention. On its own, it involves clinician education, tools in electronic medical records, and audit and feedback reports for clinician prescribing habits. The hybrid intervention includes the elements of the health systems level intervention in addition to a Shared Decision-Making component, which allows for both an increase in the role parents play in their child's care, as well as clinician education for how to use this method. The goals of this work are to increase parent satisfaction, reduce antibiotics taken for childhood ear infections, align medical care with the current national guidelines, and evaluate differences in the two intervention groups. Both groups will be evaluated for implementation outcomes to improve dissemination and scalability for future use of these models in antibiotic prescribing for children with ear infections.\n\nThis study will recruit a diverse group of patients and clinicians to complete surveys, parents to participate in focus groups, and clinicians and administrators to be interviewed in order to meet study aims and receive sufficient feedback on the interventions performed. There are two hypotheses for this research: 1. The Hybrid Intervention will have higher parent satisfaction and reduced antibiotic use compared to the Health-System Level Intervention and 2. The Hybrid Intervention will be more challenging to implement than the Health-System Level Intervention, but will be preferred by parents, clinicians, and administrators.",[28,63,64],"Ear Infection","Pediatric Infectious Disease",[66,67],"Shared Decision-Making","Health-System Level Intervention","RECRUITING","2025-08-26",{"date":71,"type":39},"2025-09-03",{"date":73,"type":39},"2025-02-03",{"date":75,"type":22},"2029-06",{"name":77,"class":78},"Intermountain Health Care, Inc.","OTHER",3,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100584882","comparison-of-amoxicillin-and-amoxicillin--clavulanic-acid-in-treating-acute-otitis-media-in-children-100584882","NCT06895135","Comparison of Amoxicillin and Amoxicillin + Clavulanic Acid in Treating Acute Otitis Media in Children","Comparison of Efficacy of Amoxicillin Plus Clavulanic Acid and Amoxicillin in Children with Acute Otitis Media","Inclusion Criteria:\n\n* Children aged 1 to 5 years\n* Diagnosed with acute otitis media (as per operational definition)\n* Both male and female participants\n* Parental consent obtained\n\nExclusion Criteria:\n\n* Children with allergies or contraindications to the trial drugs (amoxicillin or amoxicillin + clavulanic acid)\n* Children with asthma or chronic obstructive pulmonary disease (COPD) (as per medical record)\n* Children who have received treatment with the trial drugs within the past month\n* Children already enrolled in other research programs or who have received trial treatment\n* Children with any comorbid conditions that may interfere with the study","1 Year","5 Years",{"count":90,"type":22},162,[25],"This study aims to compare the effectiveness of two treatments for children with acute otitis media (middle ear infection). The two treatments being compared are amoxicillin alone and a combination of amoxicillin plus clavulanic acid. The study will help determine which treatment works better in helping children recover faster and reduce the risk of treatment failure or recurrence. By providing clearer evidence, the research aims to guide better treatment choices for children suffering from this common infection.",[28],"2025-03-25",{"date":96,"type":39},"2025-03-30",{"date":98,"type":22},"2025-05",{"date":100,"type":22},"2026-05",{"name":102,"class":78},"University of Health Sciences Lahore",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":110,"targetDuration":112,"studyType":113,"phases":4,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":133},"100509565","evaluation-of-outcomes-following-in-office-tympanostomy-using-the-tula-system-a-prospective-multi-center-registry-100509565","NCT05915078","Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry","Evaluation of Clinical and Health Economic Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry","Inclusion Criteria:\n\n* Patients ages 6 months through 17 years of age (inclusive) at time of tympanostomy in-office using the Tula® System\n* Patients who are candidates for in-office tube placement using the Tula System according to the System Instructions For Use\n\nExclusion Criteria:\n\n* Patients who are wards are not included",{"count":111,"type":22},200,"2 Years","OBSERVATIONAL","This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients aged from 6 months to 17 years of age who are undergoing an in-office ear tube placement procedure (tympanostomy) using the Tula® System. The Registry will include up to 20 centers in the US and up to 200 patients for the initial evaluation.\n\nThe FDA-approved Tula System includes the Tula Iontophoresis System (IPS) with TYMBION™ otic anesthetic for local anesthesia of the ear drum and the Tula Tube Delivery System (TDS) for ear tube placement. Clinical research established the safety, efficacy and tolerability of this system for in-office procedures in the pediatric population. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 6 months following extrusion or removal of their tube(s).",[116,28,29],"Otitis Media With Effusion",[118,119,120,121,122],"Otitis media","pediatric","tympanostomy","office procedure","local anesthesia","2024-07-19",{"date":125,"type":39},"2024-07-23",{"date":127,"type":39},"2023-06-15",{"date":129,"type":22},"2027-06-30",{"name":131,"class":132},"Smith & Nephew, Inc.","INDUSTRY",6]