[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypoxic-ischemic-encephalopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypoxic-ischemic-encephalopathy":56},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,39,68,110,136,162,194,220,248,318,344,369,397,423,453,482,509,535,561,593,632],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100256803","early-phase-1-melatonin-as-a-neuroprotective-therapy-in-neonates-with-hie-undergoing-hypothermia-100256803",false,"NCT02621944","Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia","Inclusion Criteria:\n\n* Eligible infants are \\>36 0\u002F7th weeks gestation,\n* pH (cord or neonatal) \\\u003C7.0,\n* base deficit \\>16 mEq\u002FL,\n* no available blood gas,\n* a cord blood\u002Ffirst hour of life blood gas with pH \\> 7.0 and \\\u003C 7.15,\n* base deficit between 10 and 15.9 mEq\u002FL,\n* infants must have a history of an acute perinatal event,\n* either a 10-minute Apgar \\\u003C 5 or a continued need for ventilation,\n* All infants must have signs of encephalopathy within 6 hours of age using the modified Sarnat scoring system,\n* neonates cooled within 6 hours of birth will be included in the study.\n\nExclusion Criteria:\n\n* suspected inborn errors of metabolism (elevated ammonia) and hypoglycemia,\n* clinical signs and symptoms consistent with meningitis detected upon sepsis evaluation,\n* a diagnosis of congenital abdominal surgical problems along with multiple congenital anomalies and\u002For chromosomal abnormalities.","ALL","6 Hours",{"count":18,"type":19},70,"ESTIMATED","INTERVENTIONAL",[22],"EARLY_PHASE1","Hypoxic-Ischemic Encephalopathy (HIE) occurs in 20 per 1000 births. Only 47% of neonates treated with the state of the art therapy (induced systemic hypothermia) have normal outcomes. Therefore, other promising therapies that potentially work in synergy with hypothermia to improve neurologic outcomes need to be tested. One potential agent is melatonin. Melatonin is a naturally occurring substance produced mainly from the pineal gland. Melatonin is widely known for its role in regulating the circadian rhythm, but it has many other effects that may benefit infants with HI injury. Melatonin serves as a free radical scavenger, decreases inflammatory cytokines, and stimulates anti-oxidant enzymes. Therefore, melatonin may interrupt several key components in the pathophysiology of HIE, in turn minimizing cell death and improving outcomes. The research study will evaluate the neuroprotective properties and appropriate dose of Melatonin to give to infants undergoing therapeutic hypothermia for hypoxic ischemic encephalopathy.",[25],"Hypoxic Ischemic Encephalopathy","RECRUITING","2026-06-25",{"date":29,"type":30},"2026-06-29","ACTUAL",{"date":32,"type":30},"2016-11-09",{"date":34,"type":19},"2027-03",{"name":36,"class":37},"University of Florida","OTHER",2,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100486131","phase-2-a-dose-escalation-study-of-levetiracetam-in-the-treatment-of-neonatal-seizures-100486131","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.","1 Month",{"count":49,"type":19},133,[51],"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",[54,55,56,57],"Neonatal Seizure","Neonatal Encephalopathy","Hypoxic-Ischemic Encephalopathy","Seizure Newborn","2026-06-11",{"date":60,"type":30},"2026-06-15",{"date":62,"type":30},"2023-03-24",{"date":64,"type":19},"2027-12-31",{"name":66,"class":37},"University of California, San Diego",5,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":38},"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":77,"type":19},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).",[55,56,81,82],"Sedation","Sleep",[84,85,86,87,88,89,90,91,92,81,93,94,95,96,97,98],"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":102,"type":30},"2026-06-08",{"date":104,"type":19},"2026-06-01",{"date":106,"type":19},"2029-05-31",{"name":108,"class":109},"Artemis AI Labs","INDUSTRY",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":75,"sex":15,"minAge":4,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"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":119,"type":19},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.",[56,55,92],[123,124,125],"neonatal","visual evoked potential","electroretinogram","2026-05-12",{"date":128,"type":30},"2026-05-14",{"date":130,"type":30},"2020-02-24",{"date":132,"type":19},"2029-07",{"name":134,"class":37},"University of Wisconsin, Madison",1,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":75,"sex":15,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":135},"100531096","individual-cerebral-hemodynamic-oxygenation-relationships-ichor-1-100531096","NCT06195345","Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)","ICHOR 1","Inclusion Criteria:\n\n* Individuals who are able to tolerate an MRI.\n* Are patients scheduled for a clinically indicated MRI.\n* Between birth and up to 18 years.\n\nExclusion Criteria:\n\n* Presence of an MRI-incompatible device or implant (e.g. pacemakers, stents)\n* Unable to tolerate the enclosed spaces and loud noises for the duration of time in scanner required to obtain an MRI.\n* Preterm infants less than 25 weeks\n* Any patient who is clinically too unstable to extend their MRI by up-to 7.5 minutes.","1 Minute","18 Years",{"count":146,"type":19},1000,"This is an observational study in patients who require clinical anesthesia. The main purpose of this study is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by different types of anesthesia. Subjects who require clinical anesthesia for a clinical MRI and for whom the use of anesthetics for the exam are in clinical equipoise are asked to join the study. All eligible subjects will be asked to provide informed consent before participating in the study.",[149,150,151,152,56],"HIE","TBI (Traumatic Brain Injury)","TBI","Hemodynamic Instability","2026-04-24",{"date":155,"type":30},"2026-04-29",{"date":157,"type":30},"2018-11-01",{"date":159,"type":19},"2035-11-01",{"name":161,"class":37},"Children's Hospital Los Angeles",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":20,"phases":173,"briefSummary":175,"conditions":176,"keywords":180,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":135},"100503542","phase-4-hydrocortisone-therapy-optimization-during-hypothermia-treatment-in-asphyxiated-neonates-100503542","NCT05836610","Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates","Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates - a Pharmacokinetic Study","UniCort","Inclusion Criteria:\n\n* gestational age ≥ 36 weeks\n* provision of whole-body hypothermia treatment (as described by Azzopardi et al.)\n* presence of systemic hypotension (defined as a mean arterial pressure less than the gestational age in weeks)\n* indication for hydrocortisone treatment during hypothermia by the attending physician\n* indwelling arterial catheter to take blood samples without additional painful punctures: umbilical arterial catheter or peripheral arterial catheter\n* written informed parental consent\n\nExclusion Criteria:\n\n* infants who are expected to be \\> 6 hours of age (not suitable for cooling)\n* critical congenital abnormalities\n* genetic disease\n* signed informed consent is unavailable","72 Hours",{"count":172,"type":19},50,[174],"PHASE4","This is a prospective, single center, pharmacokinetic study of intravenous hydrocortisone therapy for systemic low blood pressure during hypothermia treatment in asphyxiated newborns. Patients will be allocated to hydrocortisone supplementation while receiving conventional inotropic therapy as needed.\n\nThe hypothesis is that a detailed study of hydrocortisone pharmacokinetics during therapeutic hypothermia would help to personalize steroid supplementation in asphyxiated neonates. As the overall metabolic rate decreases with lower body temperature, drug metabolism is likely to be reduced as well, and lower doses, or less frequent dosing will be sufficient to achieve the targeted steroid range and biological effects in asphyxiated neonates with relative adrenal insufficiency. Thus, the investigators are planning to measure initial, baseline serum cortisol levels and serial serum cortisol levels after hydrocortisone supplementation in cooled asphyxiated neonates.",[56,177,178,179],"Asphyxia","Hypotension","Circulatory Failure Neonatal",[181,182,183,184,56,177],"Hypothermia treatment","Relative adrenal insufficiency","Hydrocortisone supplementation","Hydrocortisone pharmacokinetics","2026-04-23",{"date":187,"type":30},"2026-04-28",{"date":189,"type":30},"2021-09-21",{"date":191,"type":19},"2027-09",{"name":193,"class":37},"Semmelweis University",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":20,"phases":204,"briefSummary":205,"conditions":206,"keywords":207,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":219},"100499048","phase-2-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-rls-0071-in-newborns-with-moderate-or-severe-hypoxic-ischemic-encephalopathy-undergoing-therapeutic-hypothermia-100499048","NCT05778188","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia","A Phase 2, Two-Stage, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia With Long-Term Follow-Up","STAR","Inclusion Criteria:\n\n1. ≥ 36 weeks gestation.\n2. Sentinel event prior to delivery such as abruption, tight nuchal cord, uterine rupture, profound bradycardia, shoulder dystocia, or cord prolapse or other acute event likely attributable for newborn depression at delivery or an acute change in the fetal status with a clinical presentation consistent with an acute sentinel event with no clearly defined etiology.\n3. Moderate or severe encephalopathy based on at least one risk of encephalopathy criterion (a) and one clinical signs of encephalopathy criterion (b):\n\n   1. Risk of encephalopathy (either):\n\n      * Blood gas drawn within 1 hour of birth, either arterial blood gas (ABG) or venous blood gas (VBG) (cord or infant) with pH ≤ 7.0 OR base deficit ≥ 16 mmol\u002FL.\n\n      OR\n      * appearance, pulse, grimace, activity, and respiration (APGAR) score ≤ 5 at 10 minutes OR\n      * The infant required assisted ventilation ≥ 10 minutes after birth (ie, endotracheal, mask ventilation, or continuous positive airway pressure \\[CPAP\\]).\n   2. Clinical signs of encephalopathy (either\u002Fboth):\n\n      * Moderate\u002FSevere encephalopathy on National Institute of Child Health and Human Development assessment.\n      * Evidence of seizures (clinical and\u002For electroencephalogram).\n4. Be eligible to receive therapeutic hypothermia.\n5. Active whole-body cooling to be started prior to 6 hours of age (passive cooling is permitted prior to active whole body cooling).\n6. Product of a singleton pregnancy.\n7. Written informed consent obtained from parent or legal guardian.\n\nExclusion Criteria:\n\n1. Inability to enroll in the study and initiate the first dose of RLS-0071 within 10 hours of life.\n2. Known major congenital and\u002For chromosomal abnormality(ies).\n3. Severe growth restriction (birth weight ≤ 1800 g).\n4. Prenatal diagnosis of brain abnormality or hydrocephalus.\n5. Patient's head circumference is \\\u003C 30 cm.\n6. 10-minute APGAR score \\\u003C 2, if available.\n7. Infants suspected of overwhelming sepsis or congenital infection based on the Investigator's clinical consideration at the time of enrollment.\n8. Persistent severe hypotension unresponsive to inotropic support (requiring \\>2 inotropes, not inclusive of hydrocortisone).\n9. Persistent severe hypoxia in the setting of 100% fraction of inspired oxygen (FiO₂) and unresponsive to nitric oxide or requiring extracorporeal membrane oxygenation (ECMO).\n10. Severe disseminated intravascular coagulation with clinical bleeding.\n11. Neonatal encephalopathy believed to be due to a cause other than perinatal hypoxia (ie, other than HIE).\n12. Moribund infants for whom withdrawal of care being considered.\n13. Suspected or confirmed fetal alcohol syndrome or suspected substance withdraw seizures.\n14. Any other condition that the investigator may consider would make the patient ineligible for the study or place the patient at an unacceptable risk (Note: this criterion would include a clinically significant \\[eg, Grade 3 or 4\\] intracranial hemorrhage).","10 Hours",{"count":18,"type":19},[51],"Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant neurocognitive disability. Despite this vital unmet medical need, no pharmacological adjunct or alternative therapy has proven beneficial in improving outcomes in neonatal HIE.\n\nRLS-0071 is a novel peptide being developed for the treatment of neonatal HIE. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of newborns with moderate or severe HIE.",[56],[208,209],"Birth Asphyxia","Anoxic brain injury","2026-04-07",{"date":212,"type":30},"2026-04-13",{"date":214,"type":30},"2023-07-27",{"date":216,"type":19},"2028-12",{"name":218,"class":109},"ReAlta Life Sciences, Inc.",15,{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":20,"phases":231,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":135},"100578360","phase-2-sildenafil-plus-hypothermia-to-treat-neonatal-encephalopathy-100578360","NCT06810284","Sildenafil Plus Hypothermia to Treat Neonatal Encephalopathy","Effect of Sildenafil in Association to Hypothermia on Survival Without Brain Lesions In Term Neonates With Hypoxic-ischemic Encephalopathy (SHINE): Pharmacokinetic Study - Step 1","SHINE1","Inclusion Criteria:\n\n* 1\u002FNeonates born at or after 36 weeks' gestation, treated by therapeutic servo-controlled hypothermia for neonatal hypoxic ischemic encephalopathy.\n\nTherapeutic hypothermia should be decided according to French national guidelines.\n\n* 2\u002F Social security coverage\n* 3\u002F Informed consent of one of the two holders of parental authority.\n\nExclusion Criteria:\n\n* 1\u002F Chromosomal aberrations and major malformations evidenced after birth\n* 2\u002F Decision for \"comfort care only\" before study drug administration,\n* 3\u002F Uncontrolled hemorrhagic syndrome,\n* 4\u002F Severe hemodynamic failure at initiation, requiring at least two therapies (including either volume expansion, hydrocortisone or inotropes)\n* 5\u002F Known hypersensitivity to the active substance or to any of the excipients\n* 6\u002F Concomitant administration of nitrates or nitric oxide donors, Inhaled Nitric Oxide, other PDE5 inhibitors, inhibitors of CYP3A4\n* 7\u002F Participation in another interventional study","12 Hours",{"count":230,"type":19},24,[51],"The main objective of this study is to assess pharmacokinetics features of IV sildenafil in neonates with hypoxic-ischemic encephalopathy and treated by controlled hypothermia. This phase 2 study will prepare a large phase 3 randomized controlled trial to demonstrate the superiority of a combinatory therapy associating IV sildenafil and controlled hypothermia compared to Placebo and controlled hypothermia, on survival without brain lesions on MRI at discharge, in neonates born after 36 weeks of gestation.",[56],[235,236,237,238],"Hypoxic-ischemic encephalopathy","Sildenafil","Neuroprotection","newborn","2026-03-30",{"date":241,"type":30},"2026-03-31",{"date":243,"type":19},"2026-10",{"date":245,"type":19},"2029-05",{"name":247,"class":37},"Assistance Publique - Hôpitaux de Paris",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":15,"minAge":256,"maxAge":257,"enrollmentInfo":258,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":260,"conditions":261,"keywords":284,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":135},"100630855","intensive-multimodal-neurorehabilitation-targeting-neuroplasticity-in-pediatric-neurodevelopmental-and-chromosomal-disorders-100630855","NCT07493096","Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders","Functional and Neurodevelopmental Outcomes Following Intensive Multimodal Neurorehabilitation in Pediatric Patients With Neurodevelopmental Disorders, Including Chromosomal Abnormalities","GEN-HOPE","Inclusion Criteria:\n\n* Pediatric participants between approximately 4 and 12 years of age at the time of enrollment.\n* Diagnosed with or presenting with neurodevelopmental, neurologic, or genetic conditions, including but not limited to:\n\n  * cerebral palsy\n  * autism spectrum disorder\n  * developmental delay\n  * hypoxic ischemic encephalopathy (HIE)\n  * traumatic brain injury\n  * sensory processing disorder\n  * chromosomal or genetic abnormalities\n  * Demonstrate functional impairments in one or more neurodevelopmental domains, including:\n* motor coordination or motor planning\n* sensory processing\n* attention or executive functioning\n* oculomotor or visual processing\n* communication\n* emotional or behavioral regulation\n* activities of daily living\n* Enrolled in and able to participate in a two-week intensive therapy program consisting of approximately 2.5 hours per day\u002F 5 days per week\n\n  * Able to complete baseline and post-program clinical assessment using clinician-observed or caregiver-reported measures.\n  * Parent or legal guardian able to provide informed consent and participate in reporting functional outcomes when applicable.\n\nExclusion Criteria:\n\n* Medical instability or acute medical condition that would prevent safe participation in an intensive therapy program.\n* Severe uncontrolled seizure activity or other neurologic condition that would interfere with participation in structured therapeutic activities, as determined by the treating clinician.\n* Behavioral or psychological conditions that would prevent safe engagement in the therapy environment despite appropriate support.\n* Inability to attend or complete the full two-week intensive program.\n* Lack of sufficient baseline or post-intervention data to assess change in functional performance.\n* Concurrent participation in another structured intervention or clinical study that would confound interpretation of functional outcomes, at the discretion of the investigator.","4 Years","12 Years",{"count":259,"type":19},100,"This observational study evaluates functional and developmental outcomes in pediatric participants undergoing a two week intensive multimodal neurorehabilitation program. The program is designed for children with neurodevelopmental disorders, including but not limited to cerebral palsy, autism spectrum disorder, developmental delay, hypoxic ischemic encephalopathy (HIE), and chromosomal or genetic abnormalities.\n\nParticipants receive individualized therapy sessions for approximately 2.5 hours per day over a two week period. The intervention is not standardized but is tailored to each child's specific needs and may include components such as sensory integration, motor planning, reflex integration, oculomotor training, executive functioning activities, communication support, and other brain based therapeutic approaches.\n\nThe purpose of this study is to observe changes in functional abilities, including attention, motor coordination, emotional regulation, communication, and activities of daily living. Outcomes are assessed using clinician observation and parent reported changes before and after the intensive program, with limited follow-up when available.\n\nThis study does not assign participants to a specific treatment as part of a research protocol. Instead, it collects real world data from children already participating in a clinical therapy program to better understand potential benefits of intensive, individualized neurorehabilitation approaches.",[262,263,264,265,266,267,268,269,270,271,272,25,273,274,275,276,277,278,279,280,281,282,283],"Neurodevelopmental Disorders","Neurodevelopmental Disorders (NDD)","Neurodevelopmental Disorders and Developmental Abnormalities","Developmental Delay (Disorder)","Cerebral Palsy (CP)","Cerebral Palsy Hemiparetic Cerebral Palsy Spasticity Gait Disorders, Neurologic Postural Balance Impairment","Cerebral Palsy Infantile","Cerebral Palsy Spastic Hemiplegic","Cerebral Palsy, Dyskinetic","Autism Spectrum Disorder","Autism Spectrum Disorder (ASD","Hypoxic Ischemic Encephalopathy (HIE)","Traumatic Brain Injury (TBI)","Sensory Processing Disorder","Chromosomal Abnormalities","Genetic Disorders","Down Syndrome (Trisomy 21)","Fragile X Syndrome (FXS)","RETT Syndrome With Proven MECP2 Mutation","Williams Syndrome","22q11.2 Deletion Syndrome","Sensorimotor Integration",[285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,262,303,304,305,306,307,308],"Photobiomodulation","Low-Level Laser Therapy","Vibration Therapy","Tactile Stimulation","Cognitive Training","Behavioral Therapy","Intensive Therapy","Pediatric Neurorehabilitation","Multimodal Therapy","Neuroplasticity","Sensory Integration","Reflex Integration","Motor Planning","Executive Function","Emotional Regulation","Functional Outcomes","Activities of Daily Living","High Frequency Therapy","Rehabilitation","Child Development Disorders","Occupational Therapy","Physical Therapy Modalities","Early Intervention","Cognitive Therapy","2026-03-19",{"date":311,"type":30},"2026-03-25",{"date":313,"type":30},"2026-03-01",{"date":315,"type":19},"2036-12-30",{"name":317,"class":37},"Healing Hope International",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":324,"enrollmentInfo":325,"targetDuration":4,"studyType":20,"phases":327,"briefSummary":329,"conditions":330,"keywords":331,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":4},"100624613","phase-1-hydrogen-in-neonatal-encephalopathy-hie-trial-100624613","NCT07411911","Hydrogen In Neonatal Encephalopathy (HIE) Trial","Inclusion Criteria:\n\n1. Infants born ≥36 weeks gestation.\n2. Any one of the following:\n\n   1. sentinel event prior to delivery, such as uterine rupture, profound fetal bradycardia, or cord prolapse\n   2. low Apgar scores (≤ 5 at 10 minutes of life)\n   3. prolonged resuscitation at birth (chest compressions and\u002For intubation and\u002For mask ventilation at 10 minutes)\n   4. severe acidosis (pH \\\u003C 7.0 from cord or neonate blood gas within 60 minutes of birth)\n   5. abnormal base excess (≤ -16 mEq\u002FL from cord gas or neonate blood gas within 60 minutes of birth)\n3. Moderate or severe encephalopathy present in the first 2 hours of life.\n4. Intubated and mechanically ventilated at the time of enrollment.\n\nExclusion Criteria:\n\n1. Enrollment in the opt-out program.\n2. Presence of known cyanotic congenital heart disease.\n3. Presence of known or suspected genetic\u002Fchromosomal syndrome or multiple congenital anomalies.\n4. Presence of known congenital malformation that is expected to require urgent surgical intervention in the neonatal period, including congenital diaphragmatic hernia (CDH), gastroschisis, omphalocele, intestinal atresia, or imperforate anus.\n5. Presence of antenatally diagnosed central nervous system malformation, including hemorrhage, hydrocephalus, or structural anomaly of the brain (eg. polymicrogyria).\n6. Need for high frequency ventilation (HFV) at time of enrollment.\n7. Patients receiving respiratory support via Drager Babylog ventilators.\n8. Study enrollment and randomization after 2 hours of age","2 Hours",{"count":326,"type":19},54,[328],"PHASE1","Despite advances in neonatal care, moderate-to-severe acute perinatal HIE in late preterm and term infants remains a cause of mortality, neurological injury, and long-term neurodevelopmental disability. The current standard of care includes therapeutic hypothermia for 72 hours, but 40-50% of infants will die or suffer significant neurodevelopmental impairment. It has been shown that administration of hydrogen gas (H2) significantly diminishes ischemic injury in swine, and that H2 administration at the dose and duration proposed herein is well-tolerated in healthy adults. The purpose of this project is to test the feasibility and safety of H2 administration as an adjunct to therapeutic hypothermia in infants with HIE. Under exemption from informed consent, infants with severe, acute brain injury at birth will be randomized to standard therapy with or without the administration of 2% hydrogen in gases administered via the ventilator, non-invasive ventilation, or nasal cannula for 72 hours.",[149,56],[56,149,332,333,334],"Hydrogen Gas","Neonates","Brain Injury","2026-02-09",{"date":337,"type":30},"2026-02-17",{"date":339,"type":19},"2026-03",{"date":341,"type":19},"2031-03",{"name":343,"class":37},"Boston Children's Hospital",{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":20,"phases":353,"briefSummary":354,"conditions":355,"keywords":357,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":368},"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":352,"type":19},40,[51],"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.",[56,356,55],"Neonatal Asphyxia",[56,358,55],"Cerebral Asphyxia","2025-12-26",{"date":361,"type":30},"2025-12-31",{"date":363,"type":30},"2023-09-06",{"date":365,"type":19},"2026-12",{"name":367,"class":109},"Pharmazz, Inc.",4,{"id":370,"slug":371,"hasResults":11,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":75,"sex":15,"minAge":376,"maxAge":377,"enrollmentInfo":378,"targetDuration":380,"studyType":78,"phases":4,"briefSummary":381,"conditions":382,"keywords":383,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":135},"100615408","a-study-of-a-blood-marker-in-newborns-with-brain-injury-caused-by-lack-of-oxygen-at-birth-100615408","NCT07292220","A Study of a Blood Marker in Newborns With Brain Injury Caused by Lack of Oxygen at Birth","Investigation of Neurofilament Light Chain (NfL) Levels in Newborns Diagnosed With Hypoxic Ischemic Encephalopathy: A Case-Control Study","Inclusion Criteria:\n\n1. Newborns with a gestational age ≥36 weeks (term)\n2. Diagnosis of hypoxic ischemic encephalopathy (HIE) based on clinical and\u002For laboratory findings\n3. Diagnosis of stage I, stage II, or stage III HIE according to the Sarnat staging system\n4. Therapeutic hypothermia (TH) treatment initiated within the first 6 hours after birth\n5. Written consent obtained from the legal parent(s) for participation in the study\n\nExclusion Criteria:\n\n1. Major congenital malformation or genetic syndrome (e.g., Trisomy 21, congenital heart disease)\n2. Newborns with suspected sepsis, metabolic disease, or other systemic disease\n3. Premature infants with a gestational age \\\u003C36 weeks\n4. Therapeutic hypothermia treatment not started on time or inadequately administered\n5. Medical conditions preventing blood sampling (e.g., severe coagulopathy, circulatory instability)","0 Days","28 Days",{"count":379,"type":19},20,"2 Weeks","Perinatal asphyxia is a significant health problem with an incidence of 1 to 8 per 1,000 live births and can lead to serious morbidity and mortality during the neonatal period. One of its most severe consequences is hypoxic-ischemic encephalopathy (HIE), a condition that causes irreversible damage to the newborn brain due to hypoxia and ischemia. HIE is one of the leading causes of long-term neurological sequelae. Therapeutic hypothermia initiated within the first six hours after birth has been shown to significantly reduce both mortality and neurodevelopmental impairments associated with HIE. However, biomarkers that can reliably predict individual treatment response or objectively demonstrate the severity of brain injury at an early stage remain limited.\n\nNeurofilament light chain (NfL) is a protein found within the cytoskeletal structure of myelinated axons. When axonal injury occurs, NfL is released into the interstitial space and subsequently enters the cerebrospinal fluid and systemic circulation, where it can be measured. Increased NfL levels have been identified in a variety of neurological conditions, including neurodegenerative disorders and traumatic brain injury. Recent findings show that both cerebrospinal fluid and serum\u002Fplasma NfL levels are elevated in newborns diagnosed with HIE, supporting its potential role as a biochemical marker of axonal injury.\n\nThe primary aim of this study is to investigate the time-dependent changes in serum NfL levels in newborns diagnosed with HIE and undergoing therapeutic hypothermia, and to evaluate the relationship between these changes, clinical findings, and neuroimaging results. For this purpose, serum NfL levels were measured at four specific time points: within the first six hours after birth (preferably cord blood), upon reaching the target cooling temperature (approximately 12-24 hours), during the rewarming phase (72-96 hours), and on the day of magnetic resonance imaging (preferably day seven). The results are expected to provide insights into the prognostic utility of NfL in HIE and contribute to determining the optimal timing for clinical sampling.\n\nThe secondary objective of the study is to compare NfL levels of newborns diagnosed with HIE to those of a control group without HIE, thereby identifying potential cut-off values that may help distinguish between affected and unaffected infants.",[56],[384,385,386,387],"Hypoxic-ischemic encephalopathy (HIE)","Neurofilament light chain (NfL)","Newborn","Therapeutic hypothermia","2025-12-05",{"date":390,"type":30},"2025-12-18",{"date":392,"type":19},"2025-12-15",{"date":394,"type":19},"2026-08-01",{"name":396,"class":37},"Mustafa Gürkan",{"id":398,"slug":399,"hasResults":11,"nctId":400,"briefTitle":401,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":15,"minAge":376,"maxAge":403,"enrollmentInfo":404,"targetDuration":4,"studyType":20,"phases":406,"briefSummary":408,"conditions":409,"keywords":411,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":38},"100574708","the-hienome-study-genome-sequencing-for-perinatal-hie-100574708","NCT06762795","The HIEnome Study: Genome Sequencing for Perinatal HIE","Inclusion Criteria:\n\n* Delivery ≥35w0d gestation\n* Diagnosed with moderate or severe HIE, or HIE with seizures\n* Undergoing total body cooling \u002F therapeutic hypothermia\n* Able to provide blood or buccal samples during birth hospitalization\n* Admitted to Texas Children's Hospital Main, West, or Woodlands NICU\n\nExclusion Criteria:\n\n* Parents\u002Ffamily not willing to allow participation\n* Inability to collect sufficient neonatal blood samples (in some circumstances, a buccal swab may be used as backup)","1 Year",{"count":405,"type":19},25,[407],"NA","Perinatal hypoxic-ischemic encephalopathy is a rare severe condition in which neonates present with encephalopathy and a clinical history suggestive of prenatal or perinatal hypoxic-ischemic injury. Emerging evidence suggests that genetic conditions are frequently identified in cases of perinatal HIE; however, it is unclear which neonates with this diagnosis warrant genetic testing. This study will offer clinical genome sequencing to neonates with HIE who are undergoing total body cooling (therapeutic hypothermia) and their parents.",[410,25,273],"Hypoxic Ischemic Encephalopathy of Newborn",[235,412,413],"Genetic testing","Genome sequencing","2025-09-25",{"date":416,"type":30},"2025-10-01",{"date":418,"type":30},"2025-05-15",{"date":420,"type":19},"2027-06-30",{"name":422,"class":37},"Baylor College of Medicine",{"id":424,"slug":425,"hasResults":11,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":11,"sex":15,"minAge":144,"maxAge":430,"enrollmentInfo":431,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":433,"conditions":434,"keywords":439,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":135},"100396710","prognostic-factors-to-regain-consciousness-100396710","NCT04445649","Prognostic Factors to Regain Consciousness","Investigation of Prognostic Factors to Regain Consciousness in Neurological Early Rehabilitation","Inclusion Criteria:\n\n* early neurological rehabilitation (phase B)\n* stroke, traumatic brain injury, hypoxic-ischemic encephalopathy\n* disorder of consciousness (coma, UWS, MCS)\n* at minimum two weeks after disease onset\n* admission to intensive care unit\n* written consent from the patient's legal representative\n* exclusion of pregnancy\n\nExclusion Criteria:\n\n* insufficient cardiorespiratory stability\n* fractures or severe infratentorial brain injuries leading to impaired auditory evoked - potentials\n* previous brain damage\n* mental disorders (dementia, depression)\n* colonization with multi-resistant pathogens\n* MRI contraindications\n* claustrophobia\n* weight \\> 120 kg","85 Years",{"count":432,"type":19},130,"The study aims to identify factors that predict the medium and long-term outcome of patients with disorders of consciousness (DOC) undergoing early neurological rehabilitation.\n\nIn this prospective, observational study, 130 DOC patients are going to be included (36 months). At study entry, different routine data, disease severity and functional status are documented for each patient. In addition, MRI, EEG and evoked potentials are measured within the first week. The level of consciousness is recorded with the Coma-Recovery-Scale-Revised and serves as the primary outcome parameter. Complications, comorbidities, functional status and leve of consciousness are assessed weekly. After eight weeks, the measurement of the MRI, the EEG and the evoked potentials are repeated. After 3, 6 and 12 months, the Glasgow Outcome Scale-Revised is used to followed up the current status of the patients.",[435,436,437,438,56],"Neurologic Disorder","Disorder of Consciousness","Traumatic Brain Injury","Stroke",[440,441,442,443],"Neurological rehabilitation","Prognosis","Outcome","Level of consciousness","2025-09-18",{"date":446,"type":30},"2025-09-19",{"date":448,"type":30},"2020-06-15",{"date":450,"type":19},"2027-12-15",{"name":452,"class":37},"BDH-Klinik Hessisch Oldendorf",{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":11,"sex":15,"minAge":256,"maxAge":460,"enrollmentInfo":461,"targetDuration":4,"studyType":20,"phases":462,"briefSummary":463,"conditions":464,"keywords":468,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":135},"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","70 Years",{"count":379,"type":19},[407],"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.",[465,438,466,56,467],"Cerebral Palsy","Premature Birth","Periventricular Leukomalacia",[469,470,471,472],"Pediatric","Mobility Aids","Assistive Technology","Spinal Stimulation","2025-08-11",{"date":475,"type":30},"2025-08-13",{"date":477,"type":30},"2022-08-04",{"date":479,"type":19},"2026-12-31",{"name":481,"class":37},"University of Washington",{"id":483,"slug":484,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":11,"sex":15,"minAge":489,"maxAge":490,"enrollmentInfo":491,"targetDuration":4,"studyType":20,"phases":493,"briefSummary":494,"conditions":495,"keywords":497,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"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\\-","1 Hour","5 Days",{"count":492,"type":19},30,[407],"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.",[56,55,496],"Pentoxifylline Adverse Reaction",[498,499],"preterm infants","nephroprotection","2025-07-19",{"date":502,"type":30},"2025-07-28",{"date":504,"type":19},"2025-07-30",{"date":506,"type":19},"2026-03-02",{"name":508,"class":37},"Alexandria University",{"id":510,"slug":4,"hasResults":11,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":11,"sex":15,"minAge":516,"maxAge":517,"enrollmentInfo":518,"targetDuration":4,"studyType":20,"phases":520,"briefSummary":521,"conditions":522,"keywords":523,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":534},"100338099","NCT03682042","Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up","A Cluster Randomized Clinical Trial of Umbilical Cord Milking Versus Early Cord Clamping on Short and Long-term Outcomes in Neonates Who Are Non-Vigorous at Birth","CORDMILK-FU","Inclusion Criteria:\n\n* Enrolled in CORDMILK trial\n* Non-vigorous at birth\n\nExclusion Criteria:\n\n* None","22 Months","26 Months",{"count":519,"type":19},3442,[407],"An extension of the CORDMILK trial, the CORDMILK follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term\u002Flate preterm infants who were non-vigorous at birth and received umbilical cord milking (UCM) or early cord clamping (ECC).",[56,208],[524],"Placental transfusion","2025-07-07",{"date":527,"type":30},"2025-07-10",{"date":529,"type":30},"2022-10-17",{"date":531,"type":19},"2027-10-30",{"name":533,"class":37},"Nemours Children's Clinic",9,{"id":536,"slug":537,"hasResults":11,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":11,"sex":15,"minAge":542,"maxAge":543,"enrollmentInfo":544,"targetDuration":4,"studyType":20,"phases":546,"briefSummary":547,"conditions":548,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":558,"locationsCount":560},"100482917","effects-of-a-physical-therapy-intervention-on-motor-delay-in-infants-admitted-to-a-neonatal-intensive-care-unit-100482917","NCT05568264","Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit","Early Detection and Therapeutic Improvement of Motor Delay in High Risk Infants: A Randomized, Controlled Trial","Inclusion Criteria:\n\nNICU admission and qualifies for Early Childhood Clinic (NICU high-risk follow up clinic) or Early Intervention due to:\n\n* BW \\\u003C1500 grams\n\nOR\n\n* Disorders of the central nervous system\n\n  * Brain injury (including but not limited to extra axial hemorrhage, any grade intraventricular or intraparenchymal hemorrhage, stroke, hypoxic ischemic encephalopathy (HIE), meningitis)\n\n    * HIE includes mild, moderate, severe exam on modified Sarnat exam, both cooled and non-cooled\n    * includes \"at risk for HIE\" with 10-minute Apgar \\\u003C7 plus pH\\\u003C7.15 or base deficit \\>\u002F=12.\n  * Brain developmental abnormalities (hydrocephalus, microcephaly, cortical dysgenesis)\n  * Cramped synchronous movements at term PMA\n\nOR\n\n* Bronchopulmonary dysplasia (BPD) defined as need for respiratory support at 36 weeks postmenstrual age in an infant born at \\\u003C32 weeks of gestation.\n\nAND\n\n* Medically stable AND able to start intervention between 34-48 weeks PMA.\n\nExclusion Criteria:\n\n(related to inability to complete intervention, sensor placement, or clinic assessments)\n\n* open wounds, skin condition precluding sensor placement\n* immune deficiencies requiring protective isolation\n* limb reduction defects\n* followed primarily in another clinic (including but not limited to meningomyelocele and related conditions\u002Ftrisomy 21)\n* bleeding disorders or ongoing need for anticoagulation\n* palliative or hospice care (for life limiting conditions including, but not limited to trisomy 18, 13)\n* known visual impairment at the time of enrollment\n* DCFS custody\n* no English-speaking caregivers\n* any other condition that would preclude participation in the study, as determined by the PI\n* previously enrolled in competing randomized trial with developmental outcome variables\n\nEach child's enrollment in the study will be approved by the child's neonatologist.","33 Weeks","48 Weeks",{"count":545,"type":19},222,[407],"Study Aims\n\nPilot study: Due to the large recruitment goal and length of the project, the study team\u002FPIs will evaluate the first cohort of 6-10 participants to refine study procedures and study-related materials. If no major modifications are made to the protocol as a result of this evaluation, data from these participants will be included for analysis.\n\nAim 1: Evaluate the efficacy of an early, evidence-based, clinical experience-based therapeutic intervention (from the NICU to 12-months corrected age) on improving motor function and reducing severity of motor delays in infants at 12-months corrected age.\n\nThe investigators hypothesize that the intervention group will demonstrate an average 8-point difference (0.5 standard deviation) compared to the standard of care group. \\[an 8-point difference is considered a clinically meaningful difference\\]\n\nAim 2: Evaluate the early effects (i.e., before 12 months) of a therapeutic intervention, provided from NICU to 12-months corrected age, on motor function and severity of motor delay.\n\nThe Investigators hypothesize that a statistically significant higher percentage of infants in the intervention group will demonstrate improved motor function and reduced severity of motor delays, compared to the standard of care group-assessed using sensors, the NSMDA and TIMP-as early as 3-months corrected age.\n\nAim 3: Evaluate whether an early intervention that focuses on caregiver engagement improves caregiver well-being.\n\nThe invetigators hypothesize that an intervention that focuses on supporting and addressing the individual needs of the caregiver will improve caregiver well-being. The investigators will evaluate these effects using the PedsQL (Family Impact Module).",[549,466,550,56,551],"Motor Delay","Intraventricular Hemorrhage","Bronchopulmonary Dysplasia","2025-05-19",{"date":554,"type":30},"2025-05-21",{"date":556,"type":30},"2022-10-01",{"date":479,"type":19},{"name":559,"class":37},"Shirley Ryan AbilityLab",3,{"id":562,"slug":563,"hasResults":11,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":11,"sex":15,"minAge":568,"maxAge":569,"enrollmentInfo":570,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":572,"conditions":573,"keywords":576,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":4},"100565710","neuromotor-development-and-motor-related-health-care-in-children-with-a-high-risk-neonatal-period-100565710","NCT06645717","Neuromotor Development and Motor Related Health Care in Children with a High Risk Neonatal Period","Neuromotor Development in Children Enrolled in the Swedish Neonatal Follow-up Program and Access to Motor Related Healthcare","Inclusion Criteria:\n\n* Included in the SNQ registry and having a follow-up protocol for 2 and\u002For 5 years of age.\n\nExclusion Criteria:\n\n* None if the above inclusion criteria ar true.","2 Years","14 Years",{"count":571,"type":19},2900,"The overall aim of the study is to evaluate the prevalence of motor- and neurological disorders (cerebral pares and other less severe motor disorders) in Swedish infants with a high-risk neonatal period and to elucidate whether these children receive motor related health care (MRHC) at 2 and or 5,5 years of age.",[574,262,466,56,575],"Motor Disorders","Small for Gestational Age At Delivery",[577,149,578,579,580,581,582,583],"brain","SGA","preterm","neurodevelopment","motor related healthcare","children","motor function","2024-10-14",{"date":586,"type":30},"2024-10-17",{"date":588,"type":19},"2025-01-01",{"date":590,"type":19},"2034-10-01",{"name":592,"class":37},"Karolinska Institutet",{"id":594,"slug":595,"hasResults":11,"nctId":596,"briefTitle":597,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":11,"sex":15,"minAge":599,"maxAge":144,"enrollmentInfo":600,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":601,"conditions":602,"keywords":608,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":630,"locationsCount":135},"100408734","systemic-biomarkers-of-brain-injury-from-hyperammonemia-100408734","NCT04602325","Systemic Biomarkers of Brain Injury From Hyperammonemia","Inclusion Criteria:\n\n1. Inherited Hyperammonemias:\n\n   1. A clinical diagnosis of 1 of 7 diagnosed urea cycle disorders:\n\n      * N-acetylglutamate Synthetase Deficiency (NAGS)\n      * Carbamyl Phosphate Synthetase Deficiency (CPSD)\n      * Ornithine Transcarbamylase Deficiency (OTCD)\n      * Argininosuccinate Synthetase Deficiency (ASD)\n      * Argininosuccinate Lyase Deficiency (ALD)\n      * Arginase Deficiency (AD)\n      * Hyperammonemia-Hyperornithinemia-Homocitrullinuria (HHH)\n   2. A clinical diagnosis of 1 of 2 organic acidemias:\n\n      * Propionic Acidemia (PA)\n      * Methylmalonic Acidemia (MMA)\n2. Acute metabolic disorder without hyperammonemia, with neurological sequelae\n\n   1. Maple Syrup Urine Disease (MSUD)\n   2. Glutaric Acidemia (GA1)\n3. Acute metabolic disorder without hyperammonemia and without neurological sequelae\n\n   * Fatty Acid Oxidation Disorders:\n   * Medium Chain-Acyl CoA Dehydrogenase Deficiency\n   * Very Long Chain-Acyl CoA Dehydrogenase Deficiency\n   * Trifunctional Protein Deficiency\n   * Long Chain Hydroxyacyl-CoA Dehydrogenase Deficiency\n   * Carnitine Palmitoyltransferase I or II Deficiency\n   * Carnitine\u002FAcylcarnitine Translocase Deficiency\n   * Primary Carnitine Transport Deficiency\n4. Hypoxic-Ischemic Encephalopathy\n\nExclusion Criteria:\n\n* Prior Solid-Organ Transplant\n* Use of any other investigational drug, biologic, or therapy or any clinical or laboratory abnormality or medical condition that, as determined by the investigator, may interfere with or obscure the biomarker measurements","7 Years",{"count":230,"type":19},"Ammonia is a waste product of protein and amino acid catabolism and is also a potent neurotoxin. High blood ammonia levels on the brain can manifest as cytotoxic brain edema and vascular compromise leading to intellectual and developmental disabilities. The following aims are proposed:\n\nAim 1 of this study will be to determine the chronology of biomarkers of brain injury in response to a hyperammonemic (HA) brain insult in patients with an inherited hyperammonemic disorder.\n\nAim 2 will be to determine if S100B, NSE, and UCHL1 are altered in patients with two other inborn errors of metabolism, Maple Syrup Urine Disease (MSUD) and Glutaric Acidemia (GA1).",[603,604,605,606,607,56],"Urea Cycle Disorder","Organic Acidemia","Maple Syrup Urine Disease","Glutaric Acidemia I","Fatty Acid Oxidation Disorder",[609,610,611,612,613,614,615,616,617,618,619,620,621,622],"N-acetylglutamate Synthetase Deficiency","Carbamyl Phosphate Synthetase Deficiency","Ornithine Transcarbamylase Deficiency","Argininosuccinate Synthetase Deficiency","Argininosuccinate Lyase Deficiency","Arginase Deficiency","Hyperammonemia-Hyperornithinemia-Homocitrullinuria","Medium Chain-Acyl CoA Dehydrogenase Deficiency","Very Long Chain-Acyl CoA Dehydrogenase Deficiency","Trifunctional Protein Deficiency","Long Chain Hydroxyacyl-CoA Dehydrogenase Deficiency","Carnitine Palmitoyltransferase I or II Deficiency","Carnitine\u002FAcylcarnitine Translocase Deficiency","Primary Carnitine Transport Deficiency","2024-02-06",{"date":625,"type":30},"2024-02-07",{"date":627,"type":30},"2020-07-09",{"date":629,"type":19},"2027-05",{"name":631,"class":37},"Children's National Research Institute",{"id":633,"slug":634,"hasResults":11,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":11,"sex":15,"minAge":640,"maxAge":641,"enrollmentInfo":642,"targetDuration":4,"studyType":20,"phases":644,"briefSummary":645,"conditions":646,"keywords":649,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":659,"locationsCount":135},"100432608","early-virtual-intervention-for-infants-with-cp-following-hie-diagnosis-100432608","NCT04913324","Early Virtual Intervention for Infants With CP Following HIE Diagnosis","The RECOVER Study - Remote Early Intervention for Cerebral Palsy to Improve Outcomes Using Virtual Care Following pERinatal Asphyxia","RECOVER","Inclusion Criteria:\n\n1. Diagnosis of moderate to severe hypoxic ischemic encephalopathy as defined based on Sarnat criteria 35\n2. Received therapeutic hypothermia\n3. Abnormal brain MRI (deep grey matter, watershed or mixed patterns of injury) in the first seven days of life\n4. Greater than or equal to 34 weeks gestation\n5. Patients are followed by the Neonatal Follow-Up Clinic at SickKids\n6. Abnormal GMA (abnormal or absent fidgety movements) at 12 weeks of age\n\nExclusion Criteria:\n\n1. Known or high suspicion of a genetic syndrome\n2. Residence post-discharge will not be with biological parents\n3. Limited fluency in English\n4. No internet access","4 Months","5 Months",{"count":643,"type":19},150,[407],"This will be a five year study that will be a prospective, randomized, controlled trial (RCT) to assess the effect of a virtual early intervention care delivery model in the provision of therapy to enhance the neurodevelopmental trajectory of infants with brain injury. In addition, the investigators will enhance understanding of the social and parental contributors to outcomes and the early health economic impact of a virtual clinic. The results of this study will help inform the design of a larger, multi-center randomized controlled trial.",[465,56,647,648],"Brain Injuries","Perinatal Hypoxia",[149,465,650,651,56,652,647,648],"Infant","Virtual Care","Follow-Up","2021-05-28",{"date":655,"type":30},"2021-06-04",{"date":657,"type":19},"2021-06-01",{"date":479,"type":19},{"name":660,"class":37},"The Hospital for Sick Children"]