[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"periventricular-leukomalacia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:periventricular-leukomalacia":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,86],{"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":72,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":52},"100479236","spinal-stimulation-and-mobility-devices-100479236","NCT05520359","Spinal Stimulation and Mobility Devices","Transcutaneous Stimulation and Mobility Device Use for Individuals With Neurologic Conditions","Inclusion Criteria:\n\n* have a neurologic condition\n* are 4-70 years of age\n* have stable medical condition\n* can perform simple cued motor tasks and who can follow 2-3 step commands\n* who are volunteering to be involved in this study\n* can provide feedback on comfort and experience during lab visits\n\nExclusion Criteria:\n\n* have significant medical disease; including uncontrolled systemic hypertension with values above 170\u002F100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation.\n* have cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention\n* have a history of uncontrolled seizures\n* have unhealed fracture or other musculoskeletal impairment that might interfere with lower extremity rehabilitation or testing activities\n* are dependent on ventilation support\n* have implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc) or drug delivery device (e.g. baclofen pump)\n* have history of orthopedic surgery in lower extremities or neurosurgery that may be a confounding factor for interpretation of the results (such as tendon transfer, tendon or muscle lengthening for spasticity management, injection therapies to lower extremity muscles, etc.) in last 12 months\n* have established osteoporosis and taking medication for osteoporosis treatment.\n* have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)\n* have active cancer","4 Years","70 Years",{"count":63,"type":22},20,[65],"NA","This research study will combine non-invasive spinal stimulation with mobility devices to examine the acute impact of the individual and combined effects of these innovative techniques on mobility in children with cerebral palsy.",[68,69,70,71,31],"Cerebral Palsy","Stroke","Premature Birth","Hypoxic-Ischemic Encephalopathy",[73,74,75,76],"Pediatric","Mobility Aids","Assistive Technology","Spinal Stimulation","2025-08-11",{"date":79,"type":45},"2025-08-13",{"date":81,"type":45},"2022-08-04",{"date":83,"type":22},"2026-12-31",{"name":85,"class":51},"University of Washington",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":96,"phases":4,"briefSummary":97,"conditions":98,"keywords":104,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100519559","pufas-in-preterm-infants-100519559","NCT06045130","PUFAs in Preterm Infants","Characteristics of PUFAs Composition in Preterm Infants and Its Impact on Disease Prognosis","PIPI","Inclusion Criteria:\n\nInfants born between 24 and 36 weeks of gestational age who are admitted within 24 hours of birth, including both premature and full-term newborns.\n\n\\-\n\nExclusion Criteria:\n\nInfants with severe congenital developmental abnormalities, those requiring external supplementation of PUFAs in addition to standard intravenous nutrition and breastfeeding, and those with a severe prognosis indicating non-survival during their hospitalization.\n\n\\-",{"count":95,"type":22},600,"OBSERVATIONAL","The research endeavors to examine the critical composition of Polyunsaturated Fatty Acids (PUFAs) in premature infants across different gestational stages and under varying disease conditions, and delineate the metabolic attributes of PUFAs in premature infants and their interplay with the onset of diseases. This study anticipates furnishing a theoretical foundation for the rationalization of PUFAs supplementation in premature infants and for informing strategies related to disease prevention and management.",[99,100,101,102,31,103],"Necrotizing Enterocolitis","Intraventricular Hemorrhage","BPD - Bronchopulmonary Dysplasia","Sepsis","Patent Ductus Arteriosus",[105],"PUFAs","NOT_YET_RECRUITING","2023-09-13",{"date":109,"type":45},"2023-09-21",{"date":109,"type":22},{"date":112,"type":22},"2026-08-31",{"name":114,"class":51},"The First Hospital of Jilin University"]