[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548759":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":31,"responsibleParty":48,"collaborators":50,"id":54,"slug":10,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":10,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":10,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":10,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Infants with with deformational head shapes",null,"Infants who have been referred for custom orthotic treatment for a deformational head shape such as deformational plagiocephaly or deformational brachycephaly.",[13],"Device: Cranial Remolding Orthosis",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Cranial Remolding Orthosis","A custom made FDA-approved cranial remolding orthosis will be retrofit with sensors used in the research.",[9],[21],"Custom Helmet",[23],{"name":24,"affiliation":5,"role":25},"Tiffany Graham, MS","PRINCIPAL_INVESTIGATOR",[27],{"name":24,"role":28,"phone":29,"phoneExt":10,"email":30},"CONTACT","2146458250","Tiffany.Graham@utsouthwestern.edu",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"UT Southwestern Medical Center","RECRUITING","Dallas","Texas","75390","United States",{"type":40,"coordinates":41},"Point",[42,43],-96.80667,32.78306,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":10,"phoneExt":10,"email":10},"Tiffany Graham",{"type":25,"investigatorFullName":47,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Associate Professor",[51],{"name":52,"class":53},"National Institute on Disability, Independent Living, and Rehabilitation Research","FED","100548759",false,"NCT06425172","Monitoring System for Cranial Orthoses","A Monitoring System for Cranial Remolding Orthoses","Inclusion Criteria:\n\n* Infants who are clinically indicated for cranial remolding orthoses for treatment of a deformational head shape (i.e. plagiocephaly \u002F brachycephaly)\n\nExclusion Criteria:\n\n* non-English speaking caregivers\n* infants with craniosynostosis or those not indicated for cranial remolding\n* infants with developmental comorbidities which affect cranial growth","ALL","3 Months","18 Months",{"count":64,"type":65},12,"ESTIMATED","OBSERVATIONAL","This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow).",[69,70,71,72],"Plagiocephaly","Brachycephaly","Deformational Plagiocephaly","Deformational Posterior Plagiocephaly","2025-07-01",{"date":75,"type":76},"2025-07-03","ACTUAL",{"date":78,"type":76},"2024-08-19",{"date":80,"type":65},"2026-06-01",{"name":5,"class":6},1]