[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-injury-fetus-and-neonate\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-injury-fetus-and-neonate":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"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":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100646821","phase-1-neonatal-white-matter-injury-trial-wrap-100646821",false,"NCT07688746","Neonatal White Matter Injury Trial (WRAP)","An Open-label, Dose-escalation, Phase I\u002FIb Clinical Trial to Assess the Safety and Pharmacokinetics of Clemastine in Preterm Neonates With White Matter Injury (WRAP)","WRAP","Inclusion Criteria:\n\n1. Born at ≤32 weeks gestational age based on prenatal ultrasound or last menstrual period (LMP).\n2. Current age of between 35-41 weeks PMA.\n3. Imaging evidence of white matter injury on any scan as defined by either brain MRI or cUS criteria:\n\n   * Brain MRI with Grade Ib WMI or higher based on the Martinez-Biarge et al 2016 criteria.\n   * cUS with Grade 3 or higher white matter abnormalities based on Miller et al 2003 criteria.\n4. Currently hospitalized in a participating intensive care nursery.\n\nExclusion Criteria:\n\n1. Known or suspected metabolic or chromosomal disorder or major congenital anomalies\n2. Major intracranial hemorrhage within the last 1 week or intracranial hemorrhage of any age that is not controlled or continuing to cause significant mass effect or midline shift.\n3. History of cardiac arrhythmia or current ongoing tachycardia with baseline heart rate \\>10% age expected norms.\n4. Hypotension requiring ongoing vasopressor or inotropic support.\n5. Not able to receive enteral medications.\n6. Clinically significant sedation due to critical illness or medications.\n7. Concomitant use of any other putative neuroprotective or myelination promoting therapy as determined by the investigator.\n8. Serum creatinine, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) \\>2x the upper limit of normal for age.\n9. Family history of epilepsy due to a confirmed or suspected genetic cause.\n10. History of confirmed seizure activity.\n11. If ≥36 weeks postmenstrual age, required respiratory support greater than 2L\u002Fmin, noninvasive positive airway pressure, or mechanical ventilation upon reaching 36 weeks postmenstrual age due to diagnosis of moderate or severe BPD.\n12. If less than 36 weeks postmenstrual age, currently requiring respiratory support greater than 2L\u002Fmin, noninvasive positive airway pressure, or mechanical ventilation, unless respiratory support is being given to promote lung development and not due to clinical need.\n13. Major medical conditions, laboratory abnormalities, or concurrent treatments that, in opinion of the investigator, may affect interpretation of study results or patient safety.","ALL","3 Weeks","20 Weeks",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The researchers are investigating a new treatment for white matter injury, which is a common type of brain injury in premature babies. The drug, clemastine, is experimental. This means that the drug is not approved by the Food and Drug Administration (FDA) for the treatment of white matter injury. The main purpose of this study is to learn whether clemastine is safe to give to infants with white matter injury. The researchers also want to understand how much clemastine gets into an infant's body when the medication is taken by mouth, and how long it stays in the body.",[28,29,30,31,32],"White Matter Injury","Brain Injury, Fetus and Neonate","Neonatal Brain Injury","Periventricular Leukomalacia","Periventricular White Matter Abnormalities",[34,35,36,37,38,39,40],"infant","neonate","brain injury","clemastine","white matter injury","prematurity","neuroprotection","RECRUITING","2026-07-26",{"date":44,"type":45},"2026-07-28","ACTUAL",{"date":42,"type":45},{"date":48,"type":22},"2031-07-01",{"name":50,"class":51},"Bridget LaMonica Ostrem, M.D., Ph.D.","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":52},"100599508","lets-co-operate-together-we-are-stronger-100599508","NCT07085403","Let's CO-OPerate! Together we Are Stronger","Let's CO-OPerate! Together we Are Stronger: Exploring the Effectiveness of the CO-OP Cognitive Problem-solving Approach in the Context of an Intensive Group Rehabilitation Training for a Paediatric Population With Executive Function Deficits and\u002For Developmental Coordination Disorders Following Brain Injury","Inclusion criteria:\n\n* Children\u002Fadolescents (8-16 years old) with coordination disorders and\u002For executive function deficits, following a acquired brain injury more than 3 months ago or a congenital brain lesion or a neurodevelopmental disorder.\n* Executive function deficits as assessed by neuropsychological tests (standardised tests and\u002For questionnaires) and\u002For coordination disorders as assessed by neuropsychological tests (standardised tests and\u002For questionnaires).\n* Vision and hearing normal or sufficient to communicate effectively (with appropriate correction where necessary).\n* Cognitive, behavioural and expressive\u002Freceptive communication skills enabling them to identify goals and participate actively in the CO-OP intervention process.\n* Membership of a health insurance scheme or beneficiary.\n* Agreement of the child\u002Fadolescent and informed consent expressed by at least one of the holders of parental authority.\n\nNon-inclusion criteria :\n\n* Children\u002Fadolescents who do not meet the inclusion criteria.\n* Children\u002Fadolescents and\u002For parents non-French-speaking.\n* Presenting intellectual difficulties, or severe problems of comprehension, memory or attention, as described in the CO-OP recommendations.\n* A diagnosed severe anxiety-depressive disorder that is not compatible with participation in the study.\n* Inability to remain involved until the end of the CO-OP intervention phase (e.g. planned move).","8 Years","16 Years",{"count":63,"type":22},12,[65],"NA","The goal of this replicated single case experimental study using a randomized multiple baseline design across participants and goals is to enable children\u002Fadolescents (aged 8-16 years) with developmental coordination disorders and\u002For executive function deficits following an acquired or congenital brain injury, to achieve their occupational goals. The aim is to make them more independents and autonomous in their daily lives. To achieve this, we're going to offer them an intensive group CO-OP (Cognitive Orientation to daily Occupational Performance Approach) rehabilitation training, and actively involving the parents. The main questions it aims to answer are:\n\n* To evaluate the improvement in occupational performance\\* (and its maintenance over time) following intervention using the CO-OP Approach.\n\n  \\*Occupational performance is a person's ability to choose, organize and engage in meaningful occupations that give them satisfaction. These occupations, determined by culture and corresponding to their age group, enable them to take care of themselves, have fun and contribute to the social and economic fabric of the community.\n* To gather parents' experiences of supporting their child during the CO-OP intervention and its follow-up phase.\n\nParticipants will be asked to identify 3 goals that they would like to achieve with the CO-OP Approach. The CO-OP intervention will take the form of two half-days a week for 5 weeks, with 1 hour 30 minutes of individual CO-OP sessions and 1 hour 30 minutes of group sessions.",[68,69,70,29],"Executive Function Deficits (EFD)","Developmental Coordination Disorder","Acquired Brain Injury (Including Stroke)",[72,73,74,75,76,77,78,79,80],"paediatric rehabilitation","occupational therapy","executive function deficits","developmental coordination disorder","acquired brain injury","fetus and neonate brain injury","Cognitive Orientation to daily Occupational Performance (CO--OP)","intensive training","individual and group rehabilitation","NOT_YET_RECRUITING","2025-08-08",{"date":84,"type":45},"2025-08-13",{"date":86,"type":22},"2025-09-01",{"date":88,"type":22},"2027-05-01",{"name":90,"class":51},"Hopitaux de Saint-Maurice"]