[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"dr. M.J.N.L. Benders\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":19,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":21,"type":22},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.",[26],"Cerebral Palsy",[28,29,30],"cerebral palsy","machine learning","diagostic tool","RECRUITING","2025-09-16",{"date":34,"type":35},"2025-09-24","ACTUAL",{"date":37,"type":35},"2023-10-06",{"date":39,"type":22},"2029-01-01",{"name":41,"class":42},"dr. M.J.N.L. Benders","OTHER",8,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100379195","phase-3-cerebrum-and-cardiac-protection-with-allopurinol-in-neonates-with-critical-congenital-heart-disease-requiring-cardiac-surgery-with-cardiopulmonary-bypass-100379195","NCT04217421","Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass","CRUCIAL","Inclusion Criteria:\n\n* Neonates with a prenatally or postnatally confirmed diagnosis of CCHD requiring (anticipated) cardiac surgery with CPB within the first 4 weeks of life.\n* Informed consent provided by both parents.\n\nExclusion Criteria:\n\n* Inability to enroll the patient before the start of delivery in case of prenatal diagnosis, or 24 hours before surgery in case of postnatal diagnosis.\n* Doubt whether the aortic arch anomaly before birth requires cardiac surgery with CPB in the neonatal period.\n* Gestational age below 36 weeks and\u002For birth weight less than 2000 gram.\n* Surgery not requiring cardiopulmonary bypass.\n* Decision for \"comfort care only\".","1 Month",{"count":53,"type":22},236,"INTERVENTIONAL",[56],"PHASE3","Neurodevelopmental impairment due to delayed brain development and brain injury is a fundamental problem in children with critical congenital heart disease (CCHD). Significant longterm motor-, cognitive-, and behavioral problems are the result of early postnatally and perioperatively induced brain injury. Allopurinol, a xanthine oxidase inhibitor, prevents the formation of toxic free oxygen radicals, thereby limiting hypoxia-reperfusion damage. Both animal and neonatal studies suggest that administration of allopurinol reduces hypoxic-ischemic brain injury, is cardioprotective, and safe. This study aims to evaluate the efficacy and safety of allopurinol administered early postnatally and perioperatively in children with a CCHD requiring cardiac surgery with cardiopulmonary bypass.",[59,60],"Congenital Heart Disease in Children","Neuroprotection",[62,60,63,64,65,66,67,68,69,70,71,72],"Congenital Heart Disease","Allopurinol","Brain injury","Cardiopulmonary bypass","Brain function","Brain oxygenation","Cardiac function","Neurodevelopmental outcome","Cardiac surgery","Hypoxic-ischemic brain injury","Neonates","2024-05-13",{"date":75,"type":35},"2024-05-16",{"date":77,"type":35},"2020-02-14",{"date":79,"type":22},"2028-12-31",{"name":41,"class":42},4,""]