[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"otitis-media-in-children\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:otitis-media-in-children":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100642730","osteopathic-manipulative-treatment-for-children-with-chronic-or-recurrent-otitis-media-100642730",false,"NCT07639775","Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media","The Role of Osteopathic Manipulative Treatment (OMT) in Children With Recurrent or Chronic Otitis Media Prior to Tympanostomy Tube Surgery: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Age 6 months to less than 7 years. (All participants)\n* Referred to an otolaryngologist (ENT) for evaluation of chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM). (All participants)\n* Planned for tympanostomy tube placement (unilateral or bilateral) pending surgical decision. (All participants)\n* At least 5 weeks between enrollment and anticipated surgical decision point. (All participants)\n\nExclusion Criteria:\n\n* Congenital or developmental conditions associated with increased otitis media risk, including but not limited to Down syndrome, cleft palate, or other craniofacial abnormalities. (All participants)\n* History of prior tympanostomy tube placement or current tympanostomy tubes in place. (All participants)\n* History of tympanic membrane perforation. (All participants)\n* Presence of preauricular pits. (All participants)\n* Patients requiring urgent or expedited surgical intervention, as determined by the treating ENT physician. (All participants)","ALL","6 Months","6 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn whether osteopathic manipulative treatment, or OMT, can reduce the need for tympanostomy tube surgery in children with recurrent or chronic otitis media who have been referred to an Ear, Nose, and Throat surgeon and are being considered for tympanostomy tube placement.\n\nThe main question it aims to answer is:\n\nCan a standardized OMT protocol, given once weekly for 4 weeks before the final surgical decision, reduce the rate of tympanostomy tube surgery in pediatric patients with recurrent or chronic otitis media?\n\nResearchers will compare children who receive the standardized OMT protocol with children who receive a placebo\u002Fcontrol manual treatment protocol to see whether OMT leads to a clinically meaningful reduction in the need for surgery.\n\nParticipants will:\n\n* Attend 4 weekly study visits before their final ENT surgical decision.\n* Receive one of several assigned combinations of standardized OMT intervention procedures and control manual procedures. Each participant's assigned treatment sequence is determined by randomization.\n* Complete study-related assessments and questionnaires related to ear symptoms and quality of life.\n* Continue their planned ENT care, including follow-up evaluation with the ENT surgeon to determine whether tympanostomy tube surgery is still recommended.",[27,28,29,30,31,32,33,34],"Otitis Media","Otitis Media Effusion","Otitis Media Recurrent","Otitis Media With Effusion in Children","Otitis Media Chronic","Otitis Media in Children","Tympanostomy Tube Insertion","Osteopathic Manipulative Treatment (OMT)","NOT_YET_RECRUITING","2026-06-06",{"date":38,"type":39},"2026-06-10","ACTUAL",{"date":41,"type":21},"2026-08-01",{"date":43,"type":21},"2028-05-31",{"name":45,"class":46},"Sarah Vidal","OTHER",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100639335","clikx-tympanostomy-tube-delivery-system-for-the-placement-of-tympanostomy-tubes-100639335","NCT07625657","CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes","A Prospective Clinical Study of the Clikx Tympanostomy Tube Delivery System for Patients Requiring the Placement of Tympanostomy Tubes","Inclusion Criteria:\n\n1. Subject is scheduled to undergo tympanostomy tube insertion.\n2. Subject is ≥ 6 months old at the time of informed consent.\n3. Subject has an ear canal diameter of ≥ 4 mm.\n4. Subject is able and willing to provide informed consent or subject's parent\u002Fguardian is able and willing to provide informed consent and subject is able and willing to provide assent as age appropriate (age 7 years to 21 years old).\n\nExclusion Criteria:\n\n1. Subjects who are pregnant as confirmed by the institution's standard pre- surgery practice.\n2. Subjects with known adverse reaction to anesthesia.\n3. Subjects with atrophic, dimeric, severely thinned and scarred, severely thickened, severely retracted, atelectatic or perforated tympanic membrane.\n4. Subjects with otitis externa.\n5. Subjects with active acute otitis media.\n6. Subjects with an ear canal diameter \\\u003C 4 mm.\n7. Ear drums that are overly vertical or horizontal\n8. Subjects with an anatomy that precludes visualization and access to the tympanic membrane, in the opinion of the investigator.\n9. Subjects with any condition that, in the opinion of the investigator, may place the subject at greater risk.\n10. Subjects with suspected middle ear tumors or vascular lesions.\n11. Subjects diagnosed with acute sensorial hearing loss\n12. Subjects with a history of surgery involving the ear drum.\n13. Subjects with hemotympanum.\n14. Subject is not able or willing to comply with study procedures and follow-up requirements, in the opinion of the investigator.",{"count":56,"type":21},80,[24],"This study looks at the safety and performance of the CLiKX device. The device is used to place ear tubes (also called ventilation tubes) in children and adults. These tubes help treat chronic ear fluid (otitis media with effusion) and other conditions where a doctor decides an ear tube is needed.\n\nIn this study, surgeons will use the CLiKX device to place an ear tube in the patient's ear. The study will check if the surgeon can place the tube correctly in the right position. The procedure will first be attempted with no anesthesia or with local anesthesia. If needed, the surgeon may then use mild sedation or general anesthesia.\n\nThe study will also look at how well patients tolerate the procedure by checking for side affects during the procedure.\n\nFinally, the study will look at how the device affects the procedure and patient safety. Researchers will review how the procedure is performed and will follow patients for up to 30 days after the procedure to continue to check for any side effects..",[27,31,28,29,32],[61,62,63,64,65],"otitis media","Tympanostomy tube","NousQ","CLiKX","myringotomy","2026-06-02",{"date":68,"type":39},"2026-06-04",{"date":70,"type":21},"2026-06",{"date":72,"type":21},"2027-08",{"name":74,"class":75},"ClinQure, Inc.","NETWORK",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100554918","respiratory-tract-microbiome-and-probiotics-in-children-with-cleft-palate-100554918","NCT06505330","Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate","Study of the Effects of Probiotics on the Upper Respiratory Tract Microbiome and the Prevention of Otitis Media With Effusion in Children With Cleft Palate","Inclusion Criteria:\n\n* cleft palate \\& lip (uni\u002Fbilateral) or cleft palate\n* No syndromal disorders\n\nExclusion Criteria:\n\n* syndromal disorder\n* history of ventilation tube placement","2 Years",{"count":85,"type":21},40,[24],"Otitis media with effusion (OME) involves fluid accumulation in the middle ear without infection, sometimes causing discomfort and hearing loss in children. Persistent middle ear fluid lasting over 3 months may require treatment, including placement of ventilation tubes if it affects hearing.\n\nChildren with a cleft palate are at higher risk for otorrea after ventilation tube placement. Treatment typically involves antibiotic drops and ear cleaning by an ENT doctor, often requiring repeated visits, which may impact quality of life for both the child and the parents.\n\nThe mouth, throat, and nose harbor bacteria that can influence ear infections. This study aims to determine if probiotics can alter the bacteria in the nasopharynx and middle ear fluid and reduce the number of episodes of eardischarge following ventilation tube placement in children with cleft palate.\n\nUsing Lacticaseibacillus rhamnosus GG and Bifidobacterium lactis BB-12 from Bactiol® Baby (Metagenics), patients will be divided into two groups: one receiving probiotic drops and one not. The study will assess if probiotics can reduce the number of episodes with ear discharge in children with cleft palate, by examining the following:\n\n1. The airway microbiome composition in children with cleft palates.\n2. Whether oral probiotics can reduce the number and duration of ear discharge episodes.",[32,89],"Cleft Palate Children",[61,91,92,93,94],"upper respiratory tract microbiome","cleft palate","probiotics","Lacticaseibacillus rhamnosus GG","RECRUITING","2024-07-10",{"date":98,"type":39},"2024-07-17",{"date":100,"type":39},"2024-06-24",{"date":102,"type":21},"2028-06-24",{"name":104,"class":46},"University Hospital, Antwerp",1]