[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574918":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":47,"centralContacts":48,"locations":58,"responsibleParty":77,"collaborators":47,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":47,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":47,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":47,"overallStatus":100,"whyStopped":47,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8,14,19,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Junior Sonographer Annotation","ACTIVE_COMPARATOR","Participants will not receive visual cues from the DeepDDH system. Junior sonographer technicians will offer preliminary interpretations before these are subjected to validation and subsequent review by expert's team.",[13],"Other: Junior sonographer measurement of DDH",{"label":15,"type":10,"description":16,"interventionNames":17},"Senior Sonographer Annotation","Participants will not receive visual cues from the DeepDDH system.",[18],"Other: Senior sonographer measurement of DDH",{"label":20,"type":21,"description":22,"interventionNames":23},"DeepDDH system Annotation","EXPERIMENTAL","Through randomization, a subset of the preliminary interpretations will be conducted by AI technology, and the study team will evaluate the degree of divergence between these AI-generated preliminary interpretations and the final interpretations.",[24],"Other: Automated annotation of the DDH measurement through deep learning",{"label":26,"type":21,"description":27,"interventionNames":28},"DeepDDH-assist Junior Sonographer Annotation","Participants will receive visual cues from the DeepDDH system.",[29],"Other: AI-assisted junior sonographer meaturement of DDH",[31,35,39,43],{"type":6,"name":32,"description":11,"armGroupLabels":33,"otherNames":34},"Junior sonographer measurement of DDH",[9],[9],{"type":6,"name":36,"description":16,"armGroupLabels":37,"otherNames":38},"Senior sonographer measurement of DDH",[15],[15],{"type":6,"name":40,"description":22,"armGroupLabels":41,"otherNames":42},"Automated annotation of the DDH measurement through deep learning",[20],[20],{"type":6,"name":44,"description":27,"armGroupLabels":45,"otherNames":46},"AI-assisted junior sonographer meaturement of DDH",[26],[26],null,[49,54],{"name":50,"role":51,"phone":52,"phoneExt":47,"email":53},"Lixin Jiang, PhD","CONTACT","+86 18930173496","jinger_28@sina.com",{"name":55,"role":51,"phone":56,"phoneExt":47,"email":57},"Mengyao Liu, PhD","+86 17521618149","mengyao_liu08@163.com",[59],{"facility":60,"status":47,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine","Shanghai","Shanghai Municipality","200127","China","CN",{"type":67,"coordinates":68},"Point",[69,70],121.45806,31.22222,{"lat":70,"lon":69},[73],{"name":74,"role":51,"phone":75,"phoneExt":47,"email":76},"Hui Cao","+86 021-6838-3364","rjllb3364@163.com",{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"PRINCIPAL_INVESTIGATOR","Lixin Jiang","Director of Department of ultrasound in medicine, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine","100574918","efficacy-study-of-deepddh-system-in-screening-infants-with-developmental-dysplasia-of-the-hip-ddh-100574918",false,"NCT06765525","Efficacy Study of DeepDDH System in Screening Infants with Developmental Dysplasia of the Hip (DDH)","Blinded Randomized Control Trail of Artificial Intelligence-Assisted Ultrasound Screening for Neonatal Hip Dysplasia in a Clinical Cohort","Inclusion Criteria:\n\n* Infants aged 28 days to 6 months who underwent DDH ultrasound examination in Renji Hospital, Shanghai Jiaotong University School of Medicine and the Sixth People's Hospital, Shanghai Jiaotong University School of Medicine between August 2014 and December 2021\n\nExclusion Criteria:\n\n* Patients lacking or incomplete ultrasound images;\n* Patients with poor image quality and unusable images after assessment, including non-compliance with Anatomical identification (Checklist I consists of seven anatomical structures: 1. Chondro-osseous border, 2. Femoral head, 3. Synovial fold, 4. Joint capsule and perichondrium, 5. Labrum, 6. Cartilagineous roof, 7. Bony roof) and Usability check (Checklist II includes three anatomical landmarks: 1. Lower limb of the os ilium, 2. Parallel middle plane, and 3. Labrum);\n* Infants with hip dysplasia caused by other diseases such as cerebral palsy, joint contracture, suppurative coxitis, etc., or with other hip diseases and limb deformities.","ALL","28 Days","6 Months",{"count":92,"type":93},1976,"ESTIMATED","INTERVENTIONAL",[96],"NA","To ascertain the efficacy of the DeepDDH system, a deep learning framework, in enhancing diagnostic accuracy and curtailing follow-up intervals for infants undergoing screening for developmental dysplasia of the hip (DDH), the researchers are executing a blinded, randomized controlled trial. This trial juxtaposes AI-only and AI-assisted assessments of DDH against sonographer interpretations across various proficiency levels in the preliminary analysis of ultrasound images.",[99],"Hip Dysplasia, Developmental","NOT_YET_RECRUITING","2025-01-03",{"date":103,"type":104},"2025-01-09","ACTUAL",{"date":106,"type":93},"2025-01-15",{"date":108,"type":93},"2025-04-30",{"name":5,"class":6},1]