[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659049":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":24,"studyPopulation":27,"armGroups":28,"interventions":24,"overallOfficials":24,"centralContacts":35,"locations":41,"responsibleParty":174,"collaborators":24,"id":176,"slug":177,"hasResults":178,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":24,"eligibilityCriteria":182,"healthyVolunteers":178,"sex":183,"minAge":184,"maxAge":24,"enrollmentInfo":185,"targetDuration":24,"studyType":188,"phases":24,"briefSummary":189,"conditions":190,"keywords":194,"overallStatus":200,"whyStopped":24,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},{"fullName":5,"class":6},"First Affiliated Hospital Xi'an Jiaotong University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Adverse neurodevelopmental outcome at 2 Years","The percentage of participants with an adverse neurodevelopmental outcome at 2 years of age will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant and Toddler Development, Second or Fourth Edition (Bayley-II or Bayley-IV), Gesell Developmental Schedules, or the Children's Neuropsychological Development Scale, according to the assessment tool and version used at each participating center. Adverse neurodevelopmental outcome will be defined according to predefined criteria based on developmental assessment scores in the cognitive, motor, and language domains, when available. MRI-derived measures will be analyzed to characterize the extent and pattern of white matter injury and to evaluate their prognostic value for subsequent neurodevelopmental outcomes. These measures will include lesion burden, semiquantitative MRI metrics, DTI-based measures, and structural disconnection measures derived from multimodal MRI.","At 2 Years of Age",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Cognitive Developmental Outcome","Cognitive development will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant and Toddler Development, Second or Fourth Edition (Bayley-II or Bayley-IV), Gesell Developmental Schedules, or the Children's Neuropsychological Development Scale, according to the assessment tool and version used at each participating center. Cognitive impairment will be defined according to predefined score thresholds.The prognostic value of MRI-derived metrics for cognitive impairment will be evaluated. These metrics will include PWML burden, lesion distribution, semi-quantitative metrics, DTI-based measures, and structural disconnection measures.","At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age",{"measure":19,"description":20,"timeFrame":17},"Motor Developmental Outcome","Motor development will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant and Toddler Development, Second or Fourth Edition (Bayley-II or Bayley-IV), Gesell Developmental Schedules, or the Children's Neuropsychological Development Scale, according to the assessment tool and version used at each participating center. Motor impairment will be defined according to predefined score thresholds. The prognostic value of MRI-derived metrics for motor impairment will be evaluated. These metrics will include PWML burden, lesion distribution, semi-quantitative metrics, DTI-based measures, and structural disconnection measures.",{"measure":22,"description":23,"timeFrame":17},"Language Developmental Outcome","Language development will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-IV), Gesell Developmental Schedules, or the Children's Neuropsychological Development Scale, when available and according to the assessment tool and version used at each participating center. Language impairment will be defined according to predefined score thresholds. The prognostic value of MRI-derived metrics for language impairment will be evaluated. These metrics will include PWML burden, lesion distribution, semi-quantitative metrics, DTI-based measures, and structural disconnection measures.",null,{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":26,"timePerspective":6,"maskingInfo":24},"COHORT","This study includes infants with punctate white matter lesions (PWML) diagnosed by conventional brain MRI. Eligible participants are infants born at a gestational age of ≥32 weeks and \\\u003C42 weeks who underwent MRI examination at a corrected gestational age of ≤45 weeks. This multicenter observational cohort study includes retrospective and prospective participants. Clinical information, MRI findings, and longitudinal neurodevelopmental outcomes will be collected to investigate MRI-based assessment methods and predictors of adverse neurodevelopmental outcomes.",[29,32],{"label":30,"type":24,"description":31,"interventionNames":24},"Moderate-to-Late Preterm Infants with PWML","This cohort includes infants born at 32 to less than 37 weeks of gestation with punctate white matter lesions diagnosed by brain MRI. Participants will undergo clinical data collection, MRI assessment, and longitudinal neurodevelopmental follow-up to evaluate developmental outcomes.",{"label":33,"type":24,"description":34,"interventionNames":24},"Term Infants with PWML","This cohort includes infants born at 37 to less than 42 weeks of gestation with punctate white matter lesions diagnosed by brain MRI. Participants will undergo clinical data collection, MRI assessment, and longitudinal neurodevelopmental follow-up to evaluate developmental outcome",[36],{"name":37,"role":38,"phone":39,"phoneExt":24,"email":40},"Jian Yang","CONTACT","+86 18991232396","yj1118@mail.xjtu.edu.cn",[42,57,70,83,96,109,122,135,148,161],{"facility":43,"status":24,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"First Affiliated Hospital of Xi'an Jiaotong University","Xi'an","Shaanxi","710061","China","CN",{"type":50,"coordinates":51},"Point",[52,53],108.92861,34.25833,{"lat":53,"lon":52},[56],{"name":37,"role":38,"phone":39,"phoneExt":24,"email":40},{"facility":58,"status":24,"city":59,"state":24,"zip":24,"country":47,"countryCode":48,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Ankang Central Hospital","Ankang",{"type":50,"coordinates":61},[62,63],109.01722,32.68,{"lat":63,"lon":62},[66],{"name":67,"role":38,"phone":68,"phoneExt":24,"email":69},"Yukun Liang","+86 0915-3284060","452838744@qq.com",{"facility":71,"status":24,"city":72,"state":24,"zip":24,"country":47,"countryCode":48,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Sichuan Provincial Maternity and Child Health Care Hospital","Chengdu",{"type":50,"coordinates":74},[75,76],104.06667,30.66667,{"lat":76,"lon":75},[79],{"name":80,"role":38,"phone":81,"phoneExt":24,"email":82},"Min Kang","+86 28 8773 8249","1073297610@qq.com",{"facility":84,"status":24,"city":85,"state":24,"zip":24,"country":47,"countryCode":48,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University","Hangzhou",{"type":50,"coordinates":87},[88,89],120.16142,30.29365,{"lat":89,"lon":88},[92],{"name":93,"role":38,"phone":94,"phoneExt":24,"email":95},"Haibin Wang","+86 0571-56005600","haibinw0818@163.com",{"facility":97,"status":24,"city":98,"state":24,"zip":24,"country":47,"countryCode":48,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Gansu Province Maternity and Child Health Hospital","Lanzhou",{"type":50,"coordinates":100},[101,102],103.83987,36.05701,{"lat":102,"lon":101},[105],{"name":106,"role":38,"phone":107,"phoneExt":24,"email":108},"Dalin Zhu","+86 0931-5188888","zdlldz@126.com",{"facility":110,"status":24,"city":111,"state":24,"zip":24,"country":47,"countryCode":48,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Qinghai Red Cross Hospital","Qinghai",{"type":50,"coordinates":113},[114,115],106.075,25.80833,{"lat":115,"lon":114},[118],{"name":119,"role":38,"phone":120,"phoneExt":24,"email":121},"Zhao Feng","+86 0971-8290706","feng001zhao@126.com",{"facility":123,"status":24,"city":124,"state":24,"zip":24,"country":47,"countryCode":48,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Shanghai Children's Hospital, School of Medicine, Shanghai Jiaotong University","Shanghai",{"type":50,"coordinates":126},[127,128],121.45806,31.22222,{"lat":128,"lon":127},[131],{"name":132,"role":38,"phone":133,"phoneExt":24,"email":134},"Haoxiang Jiang","+86 021-5297601","wyshzl@126.com",{"facility":136,"status":24,"city":137,"state":24,"zip":24,"country":47,"countryCode":48,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Hebei Children's Hospital","Shijiazhuang",{"type":50,"coordinates":139},[140,141],114.47861,38.04139,{"lat":141,"lon":140},[144],{"name":145,"role":38,"phone":146,"phoneExt":24,"email":147},"Shujing Li","+86 0311-85911234","lishujing1976@126.com",{"facility":149,"status":24,"city":150,"state":24,"zip":24,"country":47,"countryCode":48,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Children's Hospital of Soochow University","Suzhou",{"type":50,"coordinates":152},[153,154],120.59538,31.30408,{"lat":154,"lon":153},[157],{"name":158,"role":38,"phone":159,"phoneExt":24,"email":160},"WanLiang Guo","+86 0512-80693588","gwlsuzhou@163.com",{"facility":162,"status":24,"city":163,"state":24,"zip":24,"country":47,"countryCode":48,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"The Second Affiliated Hospital of Shaanxi University of Chinese Medicine","Xianyang",{"type":50,"coordinates":165},[166,167],108.70261,34.33778,{"lat":167,"lon":166},[170],{"name":171,"role":38,"phone":172,"phoneExt":24,"email":173},"Changyi Guo","+86 029-33579191","344952556@qq.com",{"type":175,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100659049","mri-based-neurodevelopmental-risk-stratification-in-infants-with-white-matter-injury-100659049",false,"NCT07860749","MRI-Based Neurodevelopmental Risk Stratification in Infants With White Matter Injury","Multicenter Study for Developing an MRI Assessment System for Neurodevelopmental Risk Stratification in Infants With White Matter Injury","Inclusion Criteria:\n\n* Gestational age ≥32 weeks and \\\u003C42 weeks at birth.\n* Brain MRI performed at a corrected gestational age ≤45 weeks.\n* Punctate white matter lesions (PWML) diagnosed by conventional brain MRI.\n\nExclusion Criteria:\n\n* Other confirmed brain lesions, such as severe intracranial hemorrhage or cerebral infarction.\n* Congenital developmental abnormalities.\n* Confirmed genetic or metabolic diseases.\n* Conditions that severely affect MRI assessment or neurological\u002Fdevelopmental evaluation.\n* Inability to complete required MRI assessment or follow-up evaluation.","ALL","1 Day",{"count":186,"type":187},260,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to develop and evaluate an MRI-based assessment system for predicting neurodevelopmental outcomes in infants with punctate white matter lesions (PWML). This is a multicenter, bidirectional cohort study that includes both a retrospective cohort identified from existing clinical and imaging databases and a prospective cohort of consecutively enrolled participants. The study aims to better understand how MRI findings are associated with later developmental outcomes and to identify imaging markers that may help stratify developmental risk.\n\nThe main questions it aims to answer are:\n\n1. Which MRI features are associated with adverse neurodevelopmental outcomes in infants with PWML?\n2. Can MRI-based quantitative assessment methods provide early risk stratification for neurodevelopmental outcomes in infants with PWML?\n\nParticipants with PWML diagnosed by brain MRI will be followed and evaluated for neurodevelopmental outcomes. Researchers will analyze clinical information and MRI findings collected from participants to develop and validate prediction models. Participants will:\n\n1. undergo brain MRI examinations according to clinical protocols;\n2. receive standardized neurodevelopmental assessments during follow-up;\n3. have their MRI findings and developmental outcomes analyzed to identify factors associated with later neurodevelopment.",[191,192,193],"Punctate White Matter Lesions","Neurodevelopmental Outcomes","Preterm Infants",[195,196,197,198,199],"Punctate white matter lesions","Preterm infants","Brain MRI","Risk stratification","Neurodevelopment","NOT_YET_RECRUITING","2026-09-30",{"date":203,"type":204},"2026-10-06","ACTUAL",{"date":206,"type":187},"2026-10",{"date":208,"type":187},"2030-12",{"name":5,"class":6},10]