[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"congenital-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:congenital-disorder":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100590649","clinical-application-of-artificial-intelligence-in-new-borns-with-cleft-lip-and-palate-100590649",false,"NCT06970158","Clinical Application of Artificial Intelligence in New Borns With Cleft Lip and Palate","Effect of Automated AI Designed Presurgical Plate Therapy on Cleft Size Reduction in Newborns With Cleft Lip and Palate : A Comparative Study","CLIP-AI","Inclusion criteria:\n\nInfants diagnosed with unilateral cleft lip and palate Age at enrollment: within the first 14 days of life (for treatment group) Age at cleft surgery: approximately 4 months Medically stable and fit to undergo intraoral scanning and cleft surgery Parent or legal guardian has provided written informed consent\n\nExclusion Criteria:\n\nSyndromic cleft lip and palate or other craniofacial syndromes Bilateral cleft lip and palate Significant comorbidities affecting feeding, growth, or surgery (e.g., cardiac anomalies) Premature infants (\\\u003C37 weeks gestational age at birth) Infants who have already undergone any presurgical orthopedic intervention elsewhere Guardians\u002F Parents unwilling or unable to comply with follow-up or study procedures","ALL","1 Day","6 Months",{"count":21,"type":22},70,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this observational study is to evaluate whether passive plate therapy using automated AI-designed devices can reduce cleft size in newborns with cleft lip and palate. The main questions it aims to answer are:\n\nDoes AI-designed passive plate therapy reduce the cleft size between birth and primary surgery? (Primary aim)\n\nHow does cleft size at the time of surgery compare between infants who received passive plate therapy and those who did not? (Secondary aim)\n\nResearchers will compare infants who received AI-designed passive plate therapy with those who received no presurgical therapy to determine whether the intervention leads to a greater reduction in cleft width.\n\nParticipants will: Undergo intraoral scans at birth and again at the time of primary surgery, around 4 months of age.\n\nReceive either no presurgical intervention or be treated with AI-designed passive plates, depending on site-specific clinical practices",[28,29],"Congenital Disorder","Cleft Lip Palate",[31,29],"artificial intelligence","RECRUITING","2025-05-13",{"date":35,"type":36},"2025-05-16","ACTUAL",{"date":38,"type":36},"2023-08-01",{"date":40,"type":22},"2025-12-31",{"name":42,"class":43},"University Hospital, Basel, Switzerland","OTHER",2]