[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hie---hypoxic---ischemic-encephalopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hie---hypoxic---ischemic-encephalopathy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,84,110,141],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100642072","phase-3-comparison-of-outcome-of-hypoxic-ischemic-encephlopathy-managed-with-combination-of-magnesium-sulphate-and-melatonin-versus-magnesium-sulphate-alone-100642072",false,"NCT07652801","COMPARISON OF OUTCOME OF HYPOXIC ISCHEMIC ENCEPHLOPATHY MANAGED WITH COMBINATION OF MAGNESIUM SULPHATE AND MELATONIN VERSUS MAGNESIUM SULPHATE ALONE","COMPARISON OF OUTCOME OF HYPOXIC ENCEPHLOPATHY MANAGED WITH MgSO4 AND MELATONIN VERSUS MgSO4 ALONE","Inclusion Criteria:\n\n* Both genders\n* Born at term i.e \\>37weeks gestation\n* With APGAR score\\\u003C5 at 1min\n* Umblical artery acidemia(PH\\\u003C7 or base deficit\\>12mmol\u002FL\n* Evidence of atleast moderate grade ofHIE on sarnat scoring.\n\nExclusion Criteria:\n\n* With congenital anamolies\n* Intrauterine growth retadation\n* suspicion of neonatal sepsis\n* Congenital heart disese and those with IEM.","ALL","1 Hour","28 Days",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","COMPARISON OF OUTCOME OF HYPOXIC ISCHEMIC ENCEPHALOPATHY MANAGED WITH COMBINATION OF MAGNESIUM SULPHATE AND MELATONIN VERSUS MAGNESIUM SULPHATE ALONE Participants of group A will have 3 doses of MgSO4 infusion at rate of 250mg\u002Fkg per day intravenous over 1hour on day 0,1,2 Participants of group B will have 5 doses of Melatonin 10mg\u002Fkg for 5days along with MgSO4. They will undergo reassessment of arterial PH and serum LDH after completion of therapy. They will be followed for length of hospital stay and time until feed is initiated.",[27],"HIE - Hypoxic - Ischemic Encephalopathy","NOT_YET_RECRUITING","2026-06-11",{"date":31,"type":32},"2026-06-17","ACTUAL",{"date":34,"type":21},"2026-07-01",{"date":36,"type":21},"2026-12-31",{"name":38,"class":39},"University of Child Health Sciences and Children's Hospital, Lahore","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":53,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":66,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100581994","assessing-intellectual-and-motor-outcomes-in-high-risk-infants-100581994","NCT06857539","Assessing Intellectual and Motor Outcomes in High-risk Infants","The ELEVATE Program for Prediction, Early Detection & Intervention in Cerebral Palsy","AIM-High","Inclusion Criteria (High Risk Group) :\n\n* Legal guardians must be able and willing to give written informed consent and to comply with the requirements of this study protocol.\n* All infants considered high risk for a diagnosis of cerebral palsy and neuro-developmental impairment will be eligible, specifically including:\n\n  * All preterm infants born ≤32 weeks Post Menstrual Age or ≤1500 gm birth weight\n  * All encephalopathic infants\n  * Neurological risk factors (e.g., cerebral birth defect, injury\u002Fmalformation on neuroimaging, persistently abnormal neurological exam)\n\n(Control Group)\n\n-A control arm will also be recruited.\n\nExclusion Criteria:\n\n* Death prior to discharge from the neonatal unit (High-Risk Infants only)\n* No parental consent (High-Risk and Control Infants)",true,"0 Days","4 Months",{"count":52,"type":21},600,"30 Months","OBSERVATIONAL","Cerebral palsy (CP) is a condition when a baby has a brain injury that affects their movement and muscle tone. Some people with CP can have other developmental issues, like learning impairments, but many do not and have isolated issues with their motor skills. Some newborns are at higher risk of developing CP, including babies born prematurely, those who have an injury to their brain, and those who have an abnormal neurological examination. However, most babies with a higher risk of CP do not develop CP. The problem is that doctors can't tell early on who will and who will not develop CP, they can only say who has a risk of it. Therefore, these babies are followed up in out-patient clinics to see how they are progressing, usually by a neonatologist (baby doctor), often a physiotherapist, and some may also be referred to services in the community like the Early Intervention Team. If there is a significant concern, doctors will often perform a scan of the baby's brain to provide more information. Even with all this follow-up, it still usually takes at least 12 months, and can be up to 2 years, to diagnose a child as having CP.\n\nIn this study the aim is to try and reduce the age of diagnosis of CP by assessing children in high-risk out-patient clinics using novel and specific examinations. We would also like to improve our ability to predict who will need help with learning, language or other non-motor outcomes. This study is being conducted at several hospitals in Ireland, including Cork University Maternity Hospital (CUMH), The Rotunda Hospital and the Coombe Women and Infants Hospital. It is being coordinated by the In4kids network and will be conducted in the INFANT Centre\u002F University College Cork (UCC). The study has been funded by Research Ireland and the Cerebral Palsy Foundation, USA.",[57,58,59,60,61,62,63,27,64,65],"Cerebral Palsy","Cerebral Palsy (CP)","Cerebral Palsy Children","High-risk Infants","Intellectual and Developmental Disabilities","Motor Impairment","Cognitive Development","Preterm","Prematurity; Extreme",[57,67,68,69,70,71,72],"High-Risk Infant Follow-up","Motor Difficulty","Intellectual Delay","Cognitive Impairment","Hypoxic--Ischaemic Encephalopathy","Prematurity","RECRUITING","2026-05-08",{"date":76,"type":32},"2026-05-13",{"date":78,"type":32},"2025-03-21",{"date":80,"type":21},"2030-07-31",{"name":82,"class":39},"University College Cork",4,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":48,"sex":16,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100624766","biomarkers-study-in-infants-with-prior-neonatal-brain-injury-100624766","NCT07413900","Biomarkers Study in Infants With Prior Neonatal Brain Injury","Early Biomarkers Study for Prediction of Executive Dysfunction and Cognitive Outcomes Among Infants With Prior Neonatal Brain Injury","Inclusion Criteria:\n\n* Child-parent dyads will be recruited to the study.\n* Children 3-24 months with and without a history of a perinatal brain injury (PBI) will be included in this study.\n* Children with PBIs will include:\n\n  * Children diagnosed during the neonatal period with hypoxic-ischemic encephalopathy,\n  * Children born at a premature gestational age (born at less than 32 weeks gestational age).\n  * Children diagnosed with cerebral palsy\n* Healthy control participants meeting inclusion criteria will include:\n\n  * healthy infants with no prior neurological (brain disorder) history\n* For all parents: the only research inclusion criteria is to be the parent or legal guardian of a newborn with perinatal brain injury or healthy control participant.\n\nExclusion Criteria:\n\n* Healthy infants to be included in the control group will not have:\n\n  * a prior history of brain injury\n  * a diagnosis of cerebral palsy\n  * a history of a neurological disorder\n  * prior admission to the Neonatal Intensive Care Unit (NICU)\n* Children with chromosomal abnormalities, genetic syndromes and major congenital malformations will be excluded from both the patient groups and the control group.\n* Parents will have no exclusionary criteria.","3 Months","24 Months",{"count":94,"type":21},100,"This research focuses on the long-term cognitive development of children, including healthy infants and those who had a perinatal brain injury. As part of this research study, children complete in-person games and assessments at UW-Madison University Hospital. Children will also take part in an EEG assessment. Parents will be asked to fill out questionnaires about their child's behavior and stress in the home.",[27,97,98,99],"Perinatal Anoxic-ischemic Brain Injury","Premature Birth","Healthy Participants","2026-02-09",{"date":102,"type":32},"2026-02-17",{"date":104,"type":32},"2023-03-13",{"date":106,"type":21},"2030-03-15",{"name":108,"class":39},"University of Wisconsin, Madison",1,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100614815","phase-4-treatment-of-seizures-in-neonate-with-hie-100614815","NCT07284498","Treatment of Seizures in Neonate With HIE","Treatment of Seizures in Neonate With Hypoxic Ischemic Encephalopathy","HIE","Inclusion Criteria:\n\n1. Neonates diagnosed with moderate or severe HIE.\n2. Presence of clinical seizures (focal \u002F generalized tonic \u002Fcolonic, myoclonic, subtle and spasms) and\u002For documented amplitude electroencephalogram (aEEG) abnormality within the first 72 hours.\n\nExclusion Criteria:\n\n1. Exclusive metabolic causes.\n2. Serum creatinine greater than 1.6 mg\u002Fdl.\n3. Known pyridoxine-dependent seizures.\n4. Prior treatment with anti-epileptic drugs.","1 Day","30 Days",{"count":121,"type":21},66,[123],"PHASE4","Aim of the study To evaluate and compare phenobarbital's and levetiracetam's safety and efficacy for treating seizures in neonates with moderate to severe HIE",[126,27],"Neonatal Seizures",[128,116,129,130],"Neonatal Seizure","Phenobarbital","Levetiracetam","2025-12-02",{"date":133,"type":32},"2025-12-16",{"date":135,"type":21},"2026-01-01",{"date":137,"type":21},"2026-10",{"name":139,"class":39},"Mansoura University",2,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":149,"maxAge":150,"enrollmentInfo":151,"targetDuration":150,"studyType":54,"phases":4,"briefSummary":153,"conditions":154,"keywords":160,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":109},"100603447","speech-of-kids-after-neonatal-encephalopathy-100603447","NCT07136636","Speech of Kids After Neonatal Encephalopathy","Investigating the Prognostic Accuracy of Different Biomarkers for Detection of Developmental Language Disorder in Children With Neonatal Encephalopathy","SANE","Children born between 2017 and 2023 with moderate to severe HIE, treated with therapeutic hypothermia at Semmelweis University Children's Hospital.\n\nInclusion criteria\n\n1. Born at ≥ 35th week of gestation\n2. Attended follow-up examinations at two years of age\n3. Has parental informed consent\n\nExclusion criteria\n\n1. Hearing loss\n2. Multilingual language environment\n3. Congenital abnormalities\n4. Metabolic disease\n5. Sudden unexpected postnatal collapse\n6. Brain injury not caused by HIE\n7. Severe motor impairment defined as a score \\\u003C70 on the psychomotor development index (PDI) at 2 years of age","0 Years","7 Years",{"count":152,"type":21},93,"The goal of this ambispective cohort study is to reveal the early indicators of delayed language development in children born with hypoxic-ischemic encephalopathy (HIE).\n\nWe will examine the prognostic accuracy of different biomarkers, with a special focus on the ADC values of the corpus callosum.\n\nThe main questions it aims to answer are:\n\n1. To what extent does hypoxic-ischemic encephalopathy (HIE) in infancy affect intellectual development (IQ), receptive and expressive language abilities at different levels of the language system, and memory capacities related to language development?\n2. What is the relationship between early biomarkers of brain injury-such as blood gas levels, lactate, aEEG, and MRI findings (Weeke scoring system, ADC values of the corpus callosum)-and long-term cognitive developmental outcomes?\n3. What is the incidence of autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) in this high-risk population of infants with HIE?\n4. Is there an association between the Weeke Total Score and long-term language developmental outcomes?\n5. Can restricted diffusion (ADC values) of the splenium of the corpus callosum serve as an early neuroradiological marker of developmental language disorder (DLD)?\n\nOur participants are children born between 2017 and 2023 with moderate to severe HIE, treated with therapeutic hypothermia at Semmelwies University Children's Hospital. During their first days of life, several neonatal measurements were taken (blood gas markers, aEEG etc.), and at day 4-5, they had an MRI scan of their brain. The MRI scans will be reanalyzed, using the Weeke MRI scoring system. These children underwent a neurodevelopmental follow-up at the age of 2 years and currently, they will have another follow-up at the age of 4-7 years.",[27,155,156,157,158,159],"Language Delay","Autism","ADHD - Attention Deficit Disorder With Hyperactivity","Specific Language Impairment","Intellectual Developmental Disorder",[27,161,162,163,164,165,166,167],"delayed language development","neurodevelopment","MRI","biomarker","corpus callosum diffusion restriction","IQ","newborn prediction tool","2025-08-14",{"date":170,"type":32},"2025-08-22",{"date":172,"type":32},"2025-04-01",{"date":174,"type":21},"2026-12",{"name":176,"class":39},"Semmelweis University"]