[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neonatal-encephalopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neonatal-encephalopathy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,44,87,113,145,165,193,218,238,259,285,320,348,377,407,434],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100486131","phase-2-a-dose-escalation-study-of-levetiracetam-in-the-treatment-of-neonatal-seizures-100486131",false,"NCT05610085","A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures","A Phase IIb Dose Escalation Study of Levetiracetam for the Treatment of Neonatal Seizures","NEOLEV3","Inclusion Criteria:\n\n* at risk for seizures or suspected to be having seizures;\n* all seizure aetiologies except correctable metabolic abnormalities such as hypoglycaemia and hypocalcaemia;\n* Term neonates (corrected gestational age between 35 and 44 weeks, postnatal age less than 28 days);\n* weight \\> 2200g.\n* Parental ability to comprehend and provide written informed consent\n\nExclusion Criteria:\n\n* Cumulative seizure burden of 8 minutes\u002F hour or more in phases 1 and 2, Cumulative seizure burden of 20 minutes\u002Fhour or more in phase 3;\n* Renal failure defined as anuria in the first 24 hours of life;\n* Subjects in whom death seems imminent;\n* Seizures caused by correctable metabolic abnormality, such as hypocalcaemia, hypoglycaemia.","ALL","1 Month",{"count":20,"type":21},133,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The main purpose of this study is to determine the maximum safe tolerated dose of LEV in the treatment of neonatal seizures. Our hypothesis is that optimal dosing of Levetiracetam (LEV) to treat neonatal seizures is significantly greater than 60mg\u002Fkg. This study will be an open label dose-escalation, preliminary safety and efficacy study. There will be a randomized control treatment component. Infants recognized as having neonatal seizures or as being at risk of developing seizures will be recruited and started on continuous video EEG monitoring (CEEG). Eligibility will be confirmed and consent will be obtained. In the first 2 phases of the study, neurologists will identify neonates with mild-moderate seizure burden (less than 8 minutes cumulative seizure activity per hour), appropriate for study with LEV, and exclude patients with higher seizure burden where treatment with PHB is more appropriate. Phase 3 of the dose escalation will only proceed if additional efficacy of LEV has been demonstrated in phases 1 and 2. In Phase 3 we will recruit neonates with seizures of greater severity up to 20 minute seizure burden\u002Fhour. This will make the final results of study more generalizable.\n\nIf seizures are confirmed, enrolled subjects will receive 60mg\u002Fkg of LEV. Subjects whose seizures persist or recur 15 minutes after the first infusion is complete, subjects will then be randomized in the dose escalation study. Patients in the dose escalation study will be randomly assigned to receive either higher dose LEV or treatment with the control drug PHB in a 3:1 allocation ratio, stratified by site.\n\nFunding Source- FDA OOPD",[27,28,29,30],"Neonatal Seizure","Neonatal Encephalopathy","Hypoxic-Ischemic Encephalopathy","Seizure Newborn","RECRUITING","2026-06-11",{"date":34,"type":35},"2026-06-15","ACTUAL",{"date":37,"type":35},"2023-03-24",{"date":39,"type":21},"2027-12-31",{"name":41,"class":42},"University of California, San Diego","OTHER",5,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100643789","neonatal-neurological-observation-with-video-ai-100643789","NCT07628829","Neonatal Neurological Observation With Video AI","NeoNOVA","Inclusion Criteria:\n\n* Signed and dated informed consent from at least one parent or legally authorized representative (LAR) who is at least 18 years old.\n* Parent\u002FLAR expresses willingness to comply with study procedures for the duration of the infant's hospital stay.\n* Infant of any sex (including intersex\u002Fundetermined) admitted to newborn services (including the NICU) at a participating hospital.\n\nExclusion Criteria:\n\n* Parents or LAR unable to provide informed consent or are under the age of 18.\n* Non-viable neonates",true,{"count":53,"type":21},200,"OBSERVATIONAL","NeoNOVA is a multi-site, prospective, single-arm, silent observational study to determine: among (Population) infants admitted to newborn services during their inpatient hospital stay, whether (Intervention) continuous bedside non-contact high definition video running real-time AI analysis of anatomic landmarks and movement, (Comparison) compared against human-labeled video frames and standardized clinical exams, will (Outcome) accurately localize infant anatomic landmarks (primary objective; outcome median position error in pixels) and demonstrate a statistically significant association between a video-derived movement index and clinical measures of patient neurological exams (secondary objective; outcomes N-PASS and modified Sarnat exams).",[28,29,57,58],"Sedation","Sleep",[60,61,62,63,64,65,66,67,68,57,69,70,71,72,73,74],"Pose AI","Neonatal","Neonate","AI","Video AI","artificial intelligence","computer vision","NICU","Encephalopathy","neonatal monitoring","movement analysis","pose estimation","machine learning","neurological assessment","spontaneous movement","NOT_YET_RECRUITING","2026-06-05",{"date":78,"type":35},"2026-06-08",{"date":80,"type":21},"2026-06-01",{"date":82,"type":21},"2029-05-31",{"name":84,"class":85},"Artemis AI Labs","INDUSTRY",2,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":51,"sex":17,"minAge":4,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":97,"conditions":98,"keywords":99,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100513897","healthy-little-eyes-100513897","NCT05971446","Healthy Little Eyes","Visual Function as a Novel Outcome Measure Following Neonatal Hypoxic Ischemic Encephalopathy","HIE Neonate Inclusion Criteria:\n\n* Inpatient Neonates diagnosed with HIE\n* Pediatric patients who are less than 78 hours of age at the time of enrollment\n* Participants whose parent\u002Flegal guardian is able to complete consenting process in English\n\nHIE Neonate Exclusion Criteria:\n\n* Participants with prenatally diagnosed or congenital brain and\u002For eye abnormalities not associated with HIE, including but not limited to microphthalmia, anophthalmia, congenital cataract, eye or eyelid coloboma, congenital glaucoma, CMV retinitis, optic nerve hypoplasia, aniridia, cryptophthalmos, globe abnormalities\n* Participants who have a known central nervous system illness other than HIE, including but not limited to congenital brain malformations or congenital hydrocephalus\n* Participants whose parent\u002Flegal guardian is unable to provide informed consent, including participants who are in foster care, participants within state custody, and participants of minor parents\n\nWaisman, AFCH NBFU, or CERU Clinic HIE Patient Inclusion Criteria:\n\n* Pediatric patients who have a diagnosis of HIE and present to the Newborn Follow Up Clinic\n* Pediatric patients who are less than 36 months of age at the time of enrollment\n* Participants whose parent\u002Flegal guardian is able to complete consenting process in English\n\nWaisman, AFCH NBFU, or CERU Clinic HIE Patient Exclusion Criteria:\n\n* Participants with prenatally diagnosed or congenital brain and\u002For eye abnormalities not associated with HIE, including but not limited to microphthalmia, anophthalmia, congenital cataract, eye or eyelid coloboma, congenital glaucoma, CMV retinitis, optic nerve hypoplasia, aniridia, cryptophthalmos, globe abnormalities\n* Participants who have a known central nervous system illness not associated with HIE and its complications. Complications may include seizures, hydrocephalus, and stroke, which are NOT exclusionary. Examples of exclusionary conditions include but are not limited to traumatic brain injury outside the perinatal period, meningitis, or diagnosis of brain tumor\n* Participants whose parent\u002Flegal guardian is unable to provide informed consent, including participants who are in foster care, participants within state custody, and participants of minor parents\n\nWell Baby Inclusion Criteria:\n\n* Patient in Meriter's Newborn Nursery\n* ≥37 and \\\u003C42 weeks gestational age\n* 5-minute Apgar Score ≥7\n* Occipital Frontal Circumference (OFC) is within average limits for age (\\\u003C97th percentile and \\>3rd percentile)\n\nWell Baby Exclusion Criteria:\n\n* Admitted to the NICU for any reason\n* Known genetic abnormality\n* Diagnosed with HIE\n* Diagnosed with Hypoglycemia\n* Diagnosed with Hyperbilirubinemia requiring phototherapy\n* Identified prenatal exposure to substances, including illicit drugs, alcohol, and\u002For tobacco\n* Known or suspected neonatal infection requiring treatment (e.g., antibiotics)\n* TORCH infections\n* Abnormal newborn hearing screen\n* Abnormal toxicology screening\n* Identified as large for gestational age (LGA) or small for gestational age (SGA)\n* Participants with prenatally diagnosed or congenital eye abnormalities, including but not limited to microphthalmia, anophthalmia, congenital cataract, eye or eyelid coloboma, congenital glaucoma, CMV retinitis, optic nerve hypoplasia, aniridia, cryptophthalmos, globe abnormalities, and nystagmus\n* Subjects who have a known central nervous system illness or malformation, including but not limited to congenital brain malformations or congenital hydrocephalus\n* Participants whose parent\u002Flegal guardian is unable to provide informed consent, including subjects who are in foster care, subjects within state custody, and subjects of minor parents\n* The attending medical team does not approve","36 Months",{"count":96,"type":21},125,"The purpose of this research study is to gather more information on how eye injury is related to a baby's future development and see if eye function and brain test results can be used, along with current measures, to better diagnose and treat babies with hypoxic-ischemic encephalopathy (HIE).\n\nParticipants will undergo up to two eye exam sessions, involving both Visual Evoked Potential (VEP) and Electroretinogram (ERG) exams.",[29,28,68],[100,101,102],"neonatal","visual evoked potential","electroretinogram","2026-05-12",{"date":105,"type":35},"2026-05-14",{"date":107,"type":35},"2020-02-24",{"date":109,"type":21},"2029-07",{"name":111,"class":42},"University of Wisconsin, Madison",1,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":112},"100379853","neonate-cerebral-activity-in-immediate-post-partum-100379853","NCT04225975","Neonate Cerebral Activity in Immediate Post Partum","Evaluation of Cerebral, Hemodynamic and Neuronal Activities in Neonates in the Immediate Postpartum","POSTPARTUM","Inclusion Criteria:\n\n* Full term neonates between 36 and 41 weeks Gestational Age\n\nExclusion Criteria:\n\n* Premature neonates\n* Neonates of twin pregnancy\n* Suspicion of congenital malformation seen in antenatal ultrasound\n* Any pathology requiring pediatric care from birth\n* Newborns whose mothers had a chronic viral infection such as AIDS, hepatitis B or C, or who had a multidrug-resistant bacteria","1 Minute","15 Minutes",{"count":124,"type":21},60,[126],"NA","Neonatal anoxia-ischemia causes significant neurodevelopmental disorders. In this study the investigators want to better understand the interactions between the nervous and the hemodynamic cerebral systems during the adaptation of the neonate to ectopic life just after birth. Birth is an at risk situation of neonatal anoxic ischemia and the lack of objective criteria for cerebral tissue oxygenation has consequences on neuronal activity. Ph cord analysis is inadequate and only indirectly reflects the state of cerebral oxygenation. Both neuronal and vascular systems are part of the same functional entity and the analysis of their interactions is likely to reveal some early malfunctions of these networks.\n\nIn this study, the investigators want to develop a multi-scale, multimodal approach that allows simultaneous interrogation of both neuronal and vascular compartments during the 15 minutes after delivery. The investigators will record, with the aid of a single sensor placed on the scalp of the child, the electroencephalogram and the cerebral tissue oxygenation. The investigators will measure interactions by means of correlation analysis between both signals.",[129,28],"Anoxia-Ischemia, Brain",[129,131,132,133,134,135,136,62],"postpartum","Electroencephalography","Cerebral oxymetry","Near Infrared spectroscopy","EEG","NIRS",{"date":138,"type":35},"2026-05-13",{"date":140,"type":35},"2021-03-03",{"date":142,"type":21},"2027-01",{"name":144,"class":42},"Centre Hospitalier Universitaire, Amiens",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":112},"100605701","genetics-of-neonatal-encephalopathy-and-related-disorders-100605701","NCT07165938","Genetics of Neonatal Encephalopathy and Related Disorders","Proband Criteria:\n\nInclusion Criteria:\n\n* Diagnosed with neonatal encephalopathy during the neonatal period as documented in the electronic medical record\n* Less than 6 years old at the time of study enrollment\n* Patient at Boston Children's Hospital\n\nExclusion Criteria:\n\n* Genetic cause of NE already identified\n* Deceased prior to enrollment\n\nParent criteria:\n\nInclusion Criteria:\n\n\\- Biological parent of eligible proband (see above)",{"count":152,"type":21},300,"Investigators at Boston Children's Hospital are conducting research in order to better understand the genetic factors which may contribute to neonatal encephalopathy (NE) and related disorders. These findings may help explain the broad spectrum of clinical features and outcomes seen in individuals with a history of NE.",[28,155],"Hypoxic Ischaemic Encephalopathy (HIE)","2026-03-09",{"date":158,"type":35},"2026-03-11",{"date":160,"type":35},"2026-02-04",{"date":162,"type":21},"2035-09",{"name":164,"class":42},"Boston Children's Hospital",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":173,"maxAge":174,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":192},"100507601","phase-3-cooling-in-mild-encephalopathy-100507601","NCT05889507","Cooling in Mild Encephalopathy","Whole-body Hypothermia Versus Normothermia in Mild Neonatal Encephalopathy: A Multicentre Randomised Controlled Trial","COMET","Inclusion Criteria:\n\nAll babies born at or after 36 weeks of gestation with a birth weight of 1800g or more with birth acidosis or requiring resuscitation at birth will be screened for eligibility.\n\nParents will be approached for consent if the baby meets all the three (A + B + C) criteria below:\n\nA. Evidence of intra-partum hypoxia-ischemia defined as any of - (i) Apgar score of \\\u003C6 at 10 minutes after birth; (ii) continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth; (iii) severe birth acidosis defined as any occurrence of pH =\\\u003C7.00 or a Base deficit \\>=16mmol\u002Fl in any cord or baby gas sample within 60 minutes of birth.\n\nB. Evidence of mild hypoxic ischaemic encephalopathy defined as - two or more abnormal findings in any of the six categories of the modified Sarnat examination (level of consciousness, spontaneous activity, posture, tone, primitive reflexes, and autonomic nervous system) but not meeting the diagnosis of moderate or severe hypoxic ischaemic encephalopathy on a standardised examination performed by a certified examiner between 1 to 6 hours of age.\n\nC. Normal amplitude on aEEG performed for at least 30 minutes between 1 to 6 hours of age. Normal amplitude will be defined as upper margin of the aEEG activity more than 10 microvolts and the lower margin more than 5 microvolts on a single channel aEEG.\n\nExclusion Criteria:\n\n* Infants who meet the BAPM criteria for whole-body hypothermia\n* Infants without encephalopathy defined as less than two abnormalities on structured neurological examination.\n* Infants with major congenital or chromosomal anomalies identified prior to randomisation.\n* Infants with birthweight \\\u003C1800g.\n* Infants who have already received sedation, muscle relaxation, or anti-convulsants prior to neurological assessment.","1 Hour","6 Hours",{"count":176,"type":21},426,[178],"PHASE3","The goal of this randomised control trial is to establish the safety and efficacy of whole-body hypothermia for babies with mild hypoxic ischaemic encephalopathy, inform national and international guidelines, and establish uniform practice across the NHS.\n\nThe main questions it aims to answer are:\n\n1. Does whole-body cooling (33.5±0.5°C) initiated within six hours of birth and continued for 72 hours, improve cognitive development at 24 (±2) months of age after mild neonatal encephalopathy compared with normothermia (37±0.5°C)?\n2. Does a prospective trial-based economic evaluation support the provision of cooling therapy for mild encephalopathy in the NHS on cost-effectiveness grounds?\n\nParticipants will have the following interventions:\n\n* Randomisation into one of the following groups\n\n  * Whole body hypothermia group\n  * Targeted normothermia group\n* Bayley Scales of Infant and Toddler Development 4th Edition (Bayley-IV) examination at 24 (±2) months of age.\n\nResearchers will compare the mean Cognitive Composite Scale score from the Bayley IV examination between the two groups.",[28,181],"Newborn Asphyxia",[183],"therapeutic hypothermia",{"date":185,"type":35},"2026-02-06",{"date":187,"type":35},"2024-03-15",{"date":189,"type":21},"2030-01-01",{"name":191,"class":42},"Imperial College London",39,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":217},"100478774","phase-2-assess-safety-and-efficacy-of-sovateltide-in-hypoxic-ischemic-encephalopathy-100478774","NCT05514340","Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy","A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase-II Trial to Assess Safety, and Efficacy of Sovateltide in the Treatment of Hypoxic-ischemic Encephalopathy in Neonates","Inclusion Criteria:\n\n1. Either sex with ≥ 36 weeks of gestational age\n2. Receiving supportive management for perinatal asphyxia\n3. Perinatal depression, based on at least one of the following:\n\n   * Apgar score of \\\u003C5 at 10 minutes\n   * Need for resuscitation (chest compressions or mechanical ventilation) at birth\n   * pH \\\u003C7.00 or base deficit ≥ 16 mmol\u002Fliter in the cord or arterial blood within 60 minutes of birth\n   * Moderate\u002Fsevere encephalopathy evident by at least 3 of 6 modified Sarnat criteria, present between 1 to 6 hours of birth.\n4. Informed consent by one of the parents or a legal representative\n\nExclusion Criteria:\n\n1. Gestational age \\\u003C36 weeks\n2. Admitted to hospital 12-hours after birth\n3. A genetic or congenital condition that affects neuronal development\n4. TORCH infection\n5. Neonatal sepsis\n6. Complex congenital heart disease\n7. Severe dysmorphic feature\n8. Microcephaly (head circumference \\\u003C 2 Standard Deviations below mean for gestational age)",{"count":201,"type":21},40,[24],"Sovateltide (PMZ-1620; IRL-1620) is targeted to be used as a \"Treatment for hypoxic-ischemic encephalopathy in neonates,\" which is a life-threatening condition. Sovateltide augments neuronal progenitor cell differentiation and better mitochondrial morphology and biogenesis to activate a regenerative response in the central nervous system. The only treatment for HIE is therapeutic hypothermia with limited success, and studies indicate that sovateltide may be beneficial in these patients.",[29,205,28],"Neonatal Asphyxia",[29,207,28],"Cerebral Asphyxia","2025-12-26",{"date":210,"type":35},"2025-12-31",{"date":212,"type":35},"2023-09-06",{"date":214,"type":21},"2026-12",{"name":216,"class":85},"Pharmazz, Inc.",4,{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":237},"100269979","perinatal-brain-injury-potential-of-innovative-nirs-to-optimize-hypothermia-100269979","NCT02793999","Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia","Inclusion criteria:\n\nNeonates must be \\> 33 weeks gestational age (GA) and meet inclusion criteria for one of the two groups:\n\n1. Therapeutic Hypothermia (TH) Group:\n\n   1. Undergo TH as part of their clinical management\n   2. Parents consent to multiple measures in the first week of life.\n2. No Therapeutic Hypothermia (no-TH) Group:\n\n   1. Signs will be defined broadly as any one of the following which can be considered evidence of NE caused by HIE or other etiologies: i) Seizures alone or ii) any of the following: abnormal consciousness, difficulty maintaining respiration, difficulty feeding (presumed central origin), abnormal tone or reflexes.\n   2. Parents consent to multiple measures in the first week of life.\n\nExclusion criteria:\n\nExclusion criteria includes neonates born at GA ≤ 33 weeks or \\\u003C 2.0 kg, with implanted devices or other devices that preclude the use of MRI will be excluded from the follow up MRI session.","2 Years",{"count":96,"type":21},"The purpose of this study is to improve the ability of the investigators to monitor brain health in newborn babies at risk of brain injuries. The researchers will be using an investigational system of devices to non-invasively (that, is, without penetrating the skin), measure the amount of oxygen going to and being used by the brain. They will be taking some bedside research measurements during the babies' stay at the hospital. With these measurements, the intention is to study the role of oxygen in brain injury and test the efficacy of the research device and its potential as a permanent bedside diagnostic device.",[228,28],"Hypoxic Ischemic Brain Injury","2025-12-09",{"date":231,"type":35},"2025-12-10",{"date":233,"type":4},"2015-05",{"date":235,"type":21},"2028-05",{"name":164,"class":42},3,{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":112},"100250844","neonatal-neurologic-intensive-care-network-of-china-100250844","NCT02544100","Neonatal Neurologic Intensive Care Network of China","Inclusion Criteria:\n\n1. Postnatal age \\\u003C or = 28 days\n2. Written informed consent of parent or guardian\n\n   With one of the following items\n3. Hypoxic ischemic encephalopathy (HIE)\n4. Hydrocephalus\n5. Hypotonia\n6. Interventricular hemorrhages\n7. Intracranial calcifications\n8. Intracranial hemorrhages\n9. Meningitis and other brain infections\n10. Metabolic diseases\n11. Microcephaly\n12. Neonatal stroke\n13. Spina bifid\n14. Cerebral arteriovenous malformations (AVMs)\n15. Congenital brain malformations\n\nExclusion Criteria:\n\n1. Known other major congenital anomalies but not not neurologic disease.\n2. Failed to get sample or the volume of collected biosamples is not enough.\n3. Parents refuse consent.","28 Days",{"count":246,"type":21},2000,"The purpose of this study is to create a neonatal neurologic biological big data center named Neonatal Neurologic Intensive Care Network in China with neonatal systematic information, biological samples and genomics \\& genetic data on neonates born with neonatal severe encephalopathy. It also can predict brain injury as cerebral function monitoring through big data and recommend appropriate treatment. In addition, the following samples will be collected in a bio-bank in for future studies: blood, urine, and cerebrospinal fluid (CSF) samples.",[28,249],"Suspected Neonatal Encephalopathy","2025-09-03",{"date":252,"type":35},"2025-09-05",{"date":254,"type":35},"2015-09-01",{"date":256,"type":21},"2025-12-30",{"name":258,"class":42},"Children's Hospital of Fudan University",{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":17,"minAge":173,"maxAge":266,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":270,"conditions":271,"keywords":273,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":4},"100599733","nephroprotection-following-perinatal-asphyxia-randomized-controlled-trial-100599733","NCT07088328","Nephroprotection Following Perinatal Asphyxia: Randomized Controlled Trial","Effect of Pentoxyphylline in Nephroprotection Following Perinatal Asphyxia: Randomized Controlled Trial","Inclusion Criteria:\n\nInclusion criteria:\n\n1. Evidence of perinatal hypoxia, as indicated by at least one of the following:\n\n   1. Apgar score of less than or equal to 5 at 10 minutes.\n   2. ongoing resuscitation at 10 minutes.\n   3. pH less than 7.14 or a base deficit worse than or equal to minus 12 mmol\u002FL on cord\u002Farterial\u002Fvenous\u002Fcapillary blood gas obtained within 60 minutes of birth.\n2. Evidence of moderate to severe encephalopathy using Sarnat staging score.(14)\n3. Greater than or equal to 35 weeks gestational age.\n4. Birth weight greater than or equal to 1800 g.\n\nExclusion Criteria:\n\nNeonates with any of the following will be excluded:\n\n1\\. Birth weight less than 1800 g. 2. Major congenital malformations\u002Fchromosomal anomalies including major cardiac anomalies. 3. Preterm less than 35 weeks gestational age according to modified Ballard score. (15) 4. progressive neuromuscular disorders (eg spinal muscle atrophy). 5. Severe systemic infections (eg TORCH infection).\n\n\\-","5 Days",{"count":268,"type":21},30,[126],"The aim of this study is to determine the value of Pentoxifylline for nephroprotection in these neonates with perinatal asphyxia, using cystatin C, regional oxygenation measured near infrared spectroscopy and renal Doppler sonography.",[29,28,272],"Pentoxifylline Adverse Reaction",[274,275],"preterm infants","nephroprotection","2025-07-19",{"date":278,"type":35},"2025-07-28",{"date":280,"type":21},"2025-07-30",{"date":282,"type":21},"2026-03-02",{"name":284,"class":42},"Alexandria University",{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":293,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":296,"briefSummary":298,"conditions":299,"keywords":305,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":318,"locationsCount":112},"100573513","early-phase-1-feasibility-and-safety-of-intranasally-administered-breast-milk-in-hie-100573513","NCT06747260","Feasibility and Safety of Intranasally Administered Breast Milk in HIE","Feasibility and Safety of Intranasal Breast Milk in Hypoxic-ischaemic Encephalopathy","F-NEO-BRIGHT","Inclusion Criteria:\n\n* Moderate or severe hypoxic- ischaemic encephalopathy, receiving therapeutic hypothermia\n* ≥ 35. gestational week\n* \\\u003C 48 hours of life\n* Hypothermia treatment for 72 hours\n* Parental consent form\n\nExclusion Criteria:\n\n* Congenital malformation\n* Concurrent cerebral lesions\n* ECMO therapy\n* Contraindication of lactation\n* Mother unable or unwilling to provide fresh breast milk\n* Postpartum asphyxia","48 Hours",{"count":295,"type":21},10,[297],"EARLY_PHASE1","This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.",[155,300,28,301,302,303,304],"Hypoxic Ischemic Encephalopathy of Newborn","Neonatal Hypoxic Ischemic Encephalopathy","Brain Injury","Perinatal Asphyxia","Perinatal Asphyxia , Moderate to Severe HIE",[306,307,308,309,310,311],"Hypoxic-ischaemic encephalopathy","Neonatal encephalopathy","Perinatal asphyxia","Breast milk","Breast milk stem cells","Intranasal breast milk","2025-05-19",{"date":314,"type":35},"2025-05-22",{"date":316,"type":35},"2024-11-22",{"date":189,"type":21},{"name":319,"class":42},"Semmelweis University",{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":328,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":112},"100591812","phase-2-dexmedetomidine-versus-morphine-during-cooling-therapy-in-neonates-100591812","NCT06985290","Dexmedetomidine Versus Morphine During Cooling Therapy in Neonates","Comparative Efficacy of Dexmedetomidine Versus Morphine in Alleviating Secondary Brain Injury, When Used for Sedation During Hypothermia Therapy in Neonates: A Pilot Randomized Trial","COOL-SED","Inclusion criteria:\n\n1. Gestational age \\>= 35 weeks\n2. Birth weight \\>= 2500g\n3. Sign of perinatal hypoxic event (any of the following): (a) Arterial Cord blood gas or postnatal gas within 1 hour of life pH \\\u003C= 7.00 OR Base Deficit \\>= 16 (b) Arterial Cord blood gas postnatal gas within 1 hour of life pH 7.00 -7.15 AND Acute sentinel intrapartum event\n4. Sign of Neonatal Encephalopathy\n5. Initiation of Therapeutic Hypothermia within 8 hours of life\n\nExclusion criteria:\n\n1. Informed consent not obtained within 20 hours of life\n2. Congenital Brain Malformations (antenatally known)\n3. Major Chromosomal Anomaly (antenatally diagnosed)\n4. Congenital neuromuscular disorder","20 Hours",{"count":330,"type":21},50,[24],"About \\~3\u002F 1000 live-born newborns may suffer from brain injury due to a transient drop in oxygen supply to the brain during the birth process. The degree of brain injury that ensues in the first 72 hours after the injury is directly proportional to the severity of long-term childhood disabilities (e.g., cerebral palsy and developmental delays). Whole-body cooling during the first 3 days of life is proven effective in reducing the severity of brain injury. However, cooling therapy leads to pain, shivering, stress, and discomfort. The best way to alleviate the pain and agitation of cooled newborns is unknown. Standard practice is to provide morphine infusion to reduce pain. Recently, a new drug called \"dexmedetomidine\" has been tested in small studies and has been found to be safe during cooling in newborns. Dexmedetomidine has added beneficial effects such as anti-inflammation, faster recovery, and shorter hospital stays. This study is going to test the feasibility of conducting a future clinical trial to compare the effects of using Dexmedetomidine versus morphine in the management of cooling-related pain\u002Fagitation on the severity of brain injury in the first week of life. The study will also examine the effect of dexmedetomidine compared to morphine on short-term clinical outcomes, parental experiences and developmental outcomes at 1 year.",[228,28,334],"Perinatal Anoxic-ischemic Brain Injury",[336,337,338,339],"sedation","analgesia","dexmedetomidine","morphine","2025-05-14",{"date":314,"type":35},{"date":343,"type":21},"2025-07-01",{"date":345,"type":21},"2028-06-30",{"name":347,"class":42},"Ipsita Goswami",{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":356,"conditions":357,"keywords":364,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":376,"locationsCount":112},"100504435","natural-history-study-of-patients-with-hpdl-mutations-100504435","NCT05848271","Natural History Study of Patients with HPDL Mutations","A Patient Registry and Natural History Study of Patients with Biallelic HPDL Mutations","Inclusion Criteria:\n\n* Any individuals diagnosed with HPDL variants\n* Clinical diagnosis can include:\n\n  * HPDL-related hereditary spastic paraplegia (HSP)\n  * HPDL-related neonatal mitochondrial encephalopathy\n  * Spastic paraplegia -83 (SPG83)\n  * Neurodevelopmental disorder with progressive spasticity and brain white matter abnormalities (NEDSWMA)\n\nExclusion Criteria:\n\n* Any known genetic abnormality (other than HPDL mutation)\n* Any condition that, in the opinion of the Site Investigator, could put the participant at undue risk and\u002For would ultimately prevent the completion of study procedures",{"count":330,"type":21},"This study uses medical records that allow retrospective data extraction of clinical manifestation to assess the natural history of HPDL mutations",[358,359,360,361,28,362,363],"Mitochondrial Encephalomyopathies","Hereditary Spastic Paraplegia","Spastic Paraplegia","White Matter Disease","Mutation","Genetic Disease",[365,366,367,368,369],"HPDL","HPDL related neonatal mitochondrial encephalopathy","HPDL related hereditary spastic paraplegia","Spastic paraplegia-83","Neurodevelopmental disorder with progressive spasticity and brain white matter abnormalities","2025-03-25",{"date":372,"type":35},"2025-03-30",{"date":374,"type":35},"2023-05-18",{"date":39,"type":21},{"name":41,"class":42},{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":17,"minAge":384,"maxAge":293,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":386,"briefSummary":387,"conditions":388,"keywords":389,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":86},"100523679","phase-2-treatment-of-neonatal-encephalopathy-with-oral-sildenafil-suspension-to-repair-brain-injury-secondary-to-birth-asphyxia-100523679","NCT06098833","Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia","Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia: A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate Safety and Efficacy (Phase II Study)","Inclusion Criteria:\n\n* Male and female neonates meeting the criteria for induced hypothermia:\n* Gestational age ≥36weeks and birth weight ≥1800g;\n* Evidence of fetal distress, i.e., history of an acute perinatal event, cord pH ≤7.0 or base deficit\n\n  * 16 mEq\u002FL;\n* Evidence of neonatal distress, such as an Apgar score ≤5 at 10 minutes, postnatal blood gas pH obtained within the first hour of life ≤ 7.0 or base deficit ≤ - 16 mEq\u002FL, or a continued need for ventilation initiated at birth and continued for at least 10 minutes;\n* Evidence of moderate to severe neonatal encephalopathy by an abnormal neurological exam and\u002For an amplitude-integrated electroencephalogram (aEEG). They will receive whole-body cooling to an esophageal temperature of 33.5°C, initiated within the first 6 hours of life, continued for 72 hours, and then they will be slowly rewarmed using standard protocol.\n* Evidence of brain injury on a brain magnetic resonance imaging (MRI) performed on day 2 of life.\n\nExclusion Criteria:\n\n* Neonates with complex congenital heart disease\n* Neonates with cerebral malformations\n* Neonates with genetic syndrome\n* Neonates with intraventricular and\u002For intraparenchymal hemorrhage on MRI performed on day 2 of life\n* Moribund infants not expected to survive","0 Minutes",{"count":124,"type":21},[24],"Around the time of birth, some babies experience a condition called asphyxia, which means that their brain and other organs do not receive enough blood and\u002For oxygen to work properly. This life-threatening condition accounts for nearly 1 out of 4 deaths of all babies around the world, and often leads to severe brain damage, cerebral palsy, epilepsy, and trouble with learning and functioning in everyday life. At this time, no treatment is available to repair the brain damage caused by asphyxia. Excitingly, a drug called sildenafil (Viagra®) is already given safely to babies who suffer from increased blood pressure in their lungs' vessels. Recent studies using a laboratory model of asphyxia at birth suggest that sildenafil may also repair the brain damage caused by asphyxia. Similarly, recent small studies have shown that it is both feasible and safe to give sildenafil to human babies, who suffered from asphyxia at birth. These studies also highlight the first promising signs that sildenafil may improve how the brains of these babies work, which is consistent with the abovementioned laboratory studies.\n\nOn the basis of these previous researches, the investigators predict that sildenafil can repair the damage to a baby's brain. The investigators will test whether sildenafil can be safely given to a large group of human babies who suffer from asphyxia at birth, and will confirm whether sildenafil improves or not how their brains and hearts\u002Flungs work.\n\nThis project will enable to determine whether sildenafil is a promising treatment for repairing brain damage in babies who suffer from asphyxia at birth. This project may also provide new solutions for these babies to improve their future life.",[28],[390,391,392,393,394,395,396,397],"birth asphyxia","brain","hypoxic-ischemic encephalopathy","neonate","neuroprotection","neurorestoration","newborn","sildenafil","2025-01-13",{"date":400,"type":35},"2025-01-14",{"date":402,"type":35},"2024-07-01",{"date":404,"type":21},"2028-06",{"name":406,"class":42},"Pia Wintermark",{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":293,"enrollmentInfo":415,"targetDuration":4,"studyType":22,"phases":417,"briefSummary":418,"conditions":419,"keywords":421,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":112},"100573457","early-phase-1-intranasal-breast-milk-therapy-in-hie-100573457","NCT06746532","Intranasal Breast Milk Therapy in HIE","Neonatal Intranasal Breast Milk, Impact on Brain Growth in Hypoxic-ischemic Encephalopathy Therapy (NEO-BRIGHT)","NEO-BRIGHT","Inclusion Criteria:\n\n* Moderate or severe hypoxic- ischemic encephalopathy, receiving therapeutic hypothermia\n\n  ≥ 35. gestational week \\\u003C 48 hours of life\n* Hypothermia treatment for 72 hours\n* Parental consent form\n\nExclusion Criteria:\n\n* Congenital malformation\n* Concurrent cerebral lesions\n* ECMO therapy\n* Contraindication of lactation\n* Mother unable or unwilling to provide fresh breast milk\n* Postpartum asphyxia",{"count":416,"type":21},80,[297],"This is an open-label prospective single-center randomized controlled trial to evaluate the effect of intranasal breast milk in hypoxic-ischemic encephalopathic neonates receiving therapeutic hypothermia on long term neurodevelopmental outcome compared to standard care.",[420,28,303,301],"Hypoxic-Ischaemic Encephalopathy",[422,423,424,391,425,392],"HIE","intranasal breast milk","perinatal asphyxia","breast milk stem cells","2024-12-20",{"date":428,"type":35},"2024-12-24",{"date":430,"type":21},"2025-02-01",{"date":432,"type":21},"2030-12",{"name":319,"class":42},{"id":435,"slug":436,"hasResults":11,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":11,"sex":17,"minAge":441,"maxAge":442,"enrollmentInfo":443,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":445,"conditions":446,"keywords":450,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":86},"100497365","the-long-term-consequences-of-neonatal-encephalopathy-in-the-hypothermia-era-100497365","NCT05756296","The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era","The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era: Protocol for a Follow-up Cohort Study at 9 Years of Age","Inclusion Criteria:\n\n* born between 2014 and 2018\n* received whole-body cooling to an esophageal temperature of 33.5°C initiated within the first 6 hours of life, continued for 72 hours, and then they were slowly rewarmed received TH for moderate or severe NE\n\nExclusion Criteria:\n\nParticipants with a history of\n\n* congenital infections\n* genetic or metabolic disorders\n* major brain malformations (e.g., lissencephaly) and\n* any contraindication for MRI (e.g., metal implant, claustrophobia)","8 Years","11 Years",{"count":444,"type":21},198,"The goal of this study is to characterize the ability and related brain profiles of children with Neonatal encephalopathy (NE) - Therapeutic hypothermia (TH) at 9 years old. The main questions it aims to answer are:\n\n1. Compare executive function, attention, social cognition, behaviour, anxiety, self-esteem, and peer problems between children with NE-TH and matched peers without NE.\n2. Compare brain volumes, cortical and subcortical morphology, white matter microstructure, and myelination between children with NE-TH and matched peers without NE.\n3. Evaluate the associations of perinatal risk factors and structural brain integrity with neuropsychological deficits to inform about the potential aggravating and protective factors for neuropsychological functioning.\n\nParticipants will complete one study visit to perform standardized evaluations and a brain MRI. Parents of participants will be invited to complete a series of questionnaires during this study visit or at a moment of their choice virtually.",[28,447,448,449],"Therapeutic Hypothermia","Brain Injuries","Child Development",[451,452,62,453,454,449],"Cerebral Palsy","Brain","Developmental Delay","MRI","2023-10-19",{"date":457,"type":35},"2023-10-23",{"date":459,"type":21},"2023-11-01",{"date":461,"type":21},"2028-12-31",{"name":463,"class":42},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre"]