[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646647":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":10,"responsibleParty":22,"collaborators":10,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":29,"acronym":10,"eligibilityCriteria":30,"healthyVolunteers":26,"sex":31,"minAge":32,"maxAge":33,"enrollmentInfo":34,"targetDuration":10,"studyType":37,"phases":10,"briefSummary":38,"conditions":39,"keywords":41,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":10},{"fullName":5,"class":6},"University of Florida","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Infants with Cleft Lip and Palate Receiving Presurgical Infant Orthopedics",null,"Infants diagnosed with cleft lip and palate who receive standard of care presurgical infant orthopedic (PSIO) treatment at the Pediatric Dentistry, University of Florida. PSIO treatment approaches, including lip taping, nasoalveolar molding (NAM), prefabricated systems, or combinations of these techniques, are selected according to each infant's clinical presentation and family circumstances as part of routine clinical care. This observational study does not assign treatment. Clinical outcomes are prospectively collected and compared among the different treatment approaches.",[13,18],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Mi Sook Lee, DMD, MSD, PhD","CONTACT","352-273-7631","misooklee@ufl.edu",{"name":19,"role":15,"phone":20,"phoneExt":10,"email":21},"Marcio Guelmann, DDS","352-273-7635","guelmann@ufl.edu",{"type":23,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100646647","cleft-lip-and-palate-treatment-outcomes-study-100646647",false,"NCT07687537","Cleft Lip and Palate Treatment Outcomes Study","Outcomes of Individualized Presurgical Infant Orthopedic Treatment Approaches in Infants With Cleft Lip and Palate","Inclusion Criteria\n\n1. Diagnosis of cleft lip and or palate with clinical indication for presurgical infant orthopedic treatment\n2. Age appropriate for presurgical infant orthopedic treatment, generally from birth until surgical repair\n3. Parent or guardian ability to provide consent\n4. Willingness to comply with follow up visits to the extent feasible given family circumstances\n\nExclusion Criteria\n\n1. Other craniofacial syndromes requiring a substantially different management protocol\n2. Anticipated inability to complete any follow up\n3. Lack of parental consent","ALL","1 Day","12 Months",{"count":35,"type":36},100,"ESTIMATED","OBSERVATIONAL","Infants with cleft lip and palate often benefit from presurgical infant orthopedic treatment before surgical repair. Multiple standard of care approaches are selected based on each infant's clinical presentation and family circumstances. This prospective observational cohort study will evaluate clinical outcomes, treatment efficiency, and family burden using routinely collected clinical records and photographs to support individualized, evidence-based PSIO treatment planning.",[40],"Cleft Lip and Palate",[42,43,40,44,45],"Presurgical Infant Orthopedics","Nasoalveolar Molding","Lip Taping","Prefabricated Systems","NOT_YET_RECRUITING","2026-07-01",{"date":49,"type":50},"2026-07-07","ACTUAL",{"date":52,"type":36},"2026-08-01",{"date":54,"type":36},"2029-07-31",{"name":5,"class":6}]