[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607510":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":7,"locations":8,"responsibleParty":115,"collaborators":119,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":131,"sex":137,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":139,"studyType":143,"phases":7,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":11,"whyStopped":7,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"UMC Utrecht","OTHER",null,[9,27,40,54,68,79,90,102],{"facility":10,"status":11,"city":12,"state":7,"zip":7,"country":13,"countryCode":14,"cosmosGeoPoint":15,"geoPoint":20,"contacts":21},"Assistance Publique Hôpitaux de Paris","RECRUITING","Paris","France","FR",{"type":16,"coordinates":17},"Point",[18,19],2.3488,48.85341,{"lat":19,"lon":18},[22],{"name":23,"role":24,"phone":25,"phoneExt":7,"email":26},"Head of department of NICU, Robert Debre Hospital","CONTACT","+31 088 755 48 03","secrneon@umcutrecht.nl",{"facility":28,"status":11,"city":29,"state":7,"zip":7,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":36,"contacts":37},"University Hospital Essen","Essen","Germany","DE",{"type":16,"coordinates":33},[34,35],7.01228,51.45657,{"lat":35,"lon":34},[38],{"name":39,"role":24,"phone":25,"phoneExt":7,"email":26},"Director and Chair, Department of Paediatrics",{"facility":41,"status":11,"city":42,"state":7,"zip":7,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":49,"contacts":50},"Ospedale Pediatrico Meyer Firenze","Florence","Italy","IT",{"type":16,"coordinates":46},[47,48],11.24626,43.77925,{"lat":48,"lon":47},[51,53],{"name":52,"role":24,"phone":25,"phoneExt":7,"email":26},"Associate Professor of Child Neurology and Psychiatry",{"name":7,"role":24,"phone":7,"phoneExt":7,"email":26},{"facility":55,"status":56,"city":57,"state":7,"zip":7,"country":43,"countryCode":44,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Istituto Giannina Gaslini","NOT_YET_RECRUITING","Genova",{"type":16,"coordinates":59},[60,61],11.87211,45.21604,{"lat":61,"lon":60},[64,66],{"name":65,"role":24,"phone":25,"phoneExt":7,"email":26},"Director of the Neonatal Pathology Unit",{"name":7,"role":24,"phone":67,"phoneExt":7,"email":26},"088 755 48 03",{"facility":69,"status":11,"city":70,"state":7,"zip":7,"country":43,"countryCode":44,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Ospedale Maggiore di Milano","Milan",{"type":16,"coordinates":72},[73,74],12.59836,42.78235,{"lat":74,"lon":73},[77],{"name":78,"role":24,"phone":25,"phoneExt":7,"email":26},"Associate Professor at Clinical Sciences and Community Health",{"facility":80,"status":11,"city":81,"state":7,"zip":7,"country":43,"countryCode":44,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Fondazione Stella Maris","Pisa",{"type":16,"coordinates":83},[84,85],10.4036,43.70853,{"lat":85,"lon":84},[88],{"name":89,"role":24,"phone":25,"phoneExt":7,"email":26},"professor of paediatric neurology at the University of Pisa",{"facility":5,"status":11,"city":91,"state":7,"zip":7,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Utrecht","Netherlands","NL",{"type":16,"coordinates":95},[96,97],5.12222,52.09083,{"lat":97,"lon":96},[100],{"name":101,"role":24,"phone":25,"phoneExt":7,"email":26},"Director Neonatology",{"facility":103,"status":11,"city":104,"state":7,"zip":7,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"University Hospital La Paz","Madrid","Spain","ES",{"type":16,"coordinates":108},[109,110],-3.70256,40.4165,{"lat":110,"lon":109},[113],{"name":114,"role":24,"phone":25,"phoneExt":7,"email":26},"head of the Neonatal Intensive Care Unit",{"type":116,"investigatorFullName":117,"investigatorTitle":118,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"SPONSOR_INVESTIGATOR","dr. M.J.N.L. Benders","Prof. dr.",[120,122,125,127],{"name":121,"class":6},"Fondation Paralysie Cérébrale",{"name":123,"class":124},"Zoundream","UNKNOWN",{"name":126,"class":124},"CP Nederland",{"name":128,"class":124},"NeuroSpin","100607510","european-newborn-study-early-markers-for-a-better-life-100607510",false,"NCT07189494","European Newborn Study: Early Markers for a Better LifE","ENSEMBLE: European Newborn Study: Early Markers for a Better LifE","ENSEMBLE","Inclusion Criteria:\n\n* All infants with confirmed brain injury on MRI at high risk for CP.\n\nParticularly, infants with the following brain injuries at risk for CP will be considered on MRI at term equivalent age or within 10 days after birth or sentinel event:\n\n* Extensive punctate white matter injury.\n* Periventricular hemorrhagic infarction (any location).\n* Cerebellar injury (ischemic and\u002For hemorrhages) involving the vermis or involving more than 1\u002F3 of the cerebellar hemisphere and\u002For lesions involving the cerebellar vermis (Meijler \\& Steggerda, 2019).\n* Cystic periventricular leukomalacia (grade 3 \\& 4).\n* intraventricular hemorrhages grade III.\n* Posthemorrhagic ventricular dilatation exceeding the 97°percentile + 4mm for the ventricular index (Cizmeci et al., 2020).\n* Perinatal asphyxia with hypoxic ischemic injury of the central gray matter and\u002For perirolandic area.\n* Perinatal asphyxia with hypoxic ischemic injury in the watershed areas.\n* Perinatal ischemic arterial stroke at high risk for CP, thus with involvement of the corticospinal tracts, cortex, white matter and basal ganglia (Wagenaar et al., 2018).\n* Presence of other brain injuries with expected adverse motor outcome (i.e. big subdural and parenchymal bleedings with\u002Fwithout midline shift, bilirubin induced brain injury) in preterm infants, term infants with neonatal encephalopathy with\u002Fwithout neonatal seizures.\n\n  * Written informed parental consent (Dutch, English, French, German, Italian, Spanish).\n\nExclusion Criteria:\n\n* Infants not matching the inclusion criteria.\n* Any proven or suspected severe congenital anomaly, genetic or metabolic disorder.\n* Presence of an infection of the central nervous system.\n* Parents \\\u003C 18 years old.\n* Not being able to read one of the six Informed Consent languages.","ALL","0 Years","2 Years",{"count":141,"type":142},1000,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to create a computer model to help doctors predict any problems occurring during development of babies after being diagnosed with brain injury. This will help provide better care to future babies. Next to this, the experiences of parents or caregivers surrounding the first two years after birth of a baby at risk of developing cerebral palsy will be researched to develop recommendations to support parents.\n\nParents of participants will:\n\n\\- Fill in two online questionnaires, one when their child is 3-4 months corrected age. The second when their child is 2 years corrected age.\n\nFor the child no additional tests are needed. Only tests that are part of standard clinical practice are performed and are also saved in the study database.",[146],"Cerebral Palsy",[148,149,150],"cerebral palsy","machine learning","diagostic tool","2025-09-16",{"date":153,"type":154},"2025-09-24","ACTUAL",{"date":156,"type":154},"2023-10-06",{"date":158,"type":142},"2029-01-01",{"name":117,"class":6},8]