Clinical trials: Encephalopathy
Asphyxia Neonatorum, Hypoxia
TOBY (TOtal Body hYpothermia): a Study of Treatment for Perinatal Asphyxia
Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial encephalopathy reduces death and severe neurodevelopmental disability.
- Conditions
- Asphyxia Neonatorum, Hypoxia, Encephalopathy, Seizures
- Trial name
- NCT00147030
- Testing
- Whole body mild induced hypothermia
- Where
- United Kingdom
- Volunteers
- 325 people
- Sponsor
- Imperial College London
Developmental and Epileptic Encephalopathies, Epileptic Spasms
Ketogenic Diet for Prevention of Epileptic Spasms in Infantile Onset Genetic Epilepsies
Epileptic spasms (ES) are a predominantly infantile seizure type observed frequently in certain genetic disorders. Ketogenic diet (high ratio of fat to carbohydrate/protein) is an established non-medication treatment for…
- Conditions
- Developmental and Epileptic Encephalopathies, Epileptic Spasms, Genetic Epilepsy, Neonatal and Infant Epilepsy
- Trial name
- NCT06700811
- Testing
- Ketogenic diet
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Heather Olson
Posterior Reversible Encephalopathy Syndrome, Intensive Care Units
The Predictors of ICU Admission of oPRES
The purpose of this study is to explore the predictors of ICU admission of obstetric posterior reversible encephalopathy syndrome.
- Trial name
- NCT05310513
- Testing
- Whether the patient needs to be admitted to the ICU
- Where
- China
- Volunteers
- 366 people
- Sponsor
- Dunjin Chen
Hypoxic-Ischemic Encephalopathy Mild, Neonatal Encephalopathy
TIME Study: Therapeutic Hypothermia for Infants With Mild Encephalopathy
The TIME study is a randomized, controlled trial to evaluate impact on early measures of neurodevelopment and the safety profile of therapeutic hypothermia in term neonates with Mild Hypoxic-Ischemic Encephalopathy who are < 6…
- Trial name
- TIME (NCT04176471)
- Testing
- Therapeutic Hypothermia, Normothermia
- Where
- 5 sites in United States
- Volunteers
- 68 people
- Sponsor
- Stanford University
Hepatic Encephalopathy
PEG (Polyethylene Glycol)Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy
The current standard of care for patients with HE includes non-absorbable disaccharides(lactulose);The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose.The exact mode of action by lactulose is thought to…
- Trial name
- NCT03100513
- Testing
- Lactulose, Polyethylene Glycol
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Sherief Abd-Elsalam
Cerebral Palsy Hypoxic-Ischemic Encephalopathy Intracranial Hemorrhage
Autologous Bone Marrow Mononuclear Cell Transplantation Combined With Rehabilitation in Children With Sequelae of Hypoxic-Ischemic Encephalopathy or Intracranial Hemorrhage
This study evaluates the safety and preliminary efficacy of autologous bone marrow mononuclear cell transplantation combined with rehabilitation in children with neurological sequelae caused by hypoxic-ischemic brain injury or…
- Trial name
- BMMCT-CP (NCT07527104)
- Testing
- Autologous Bone Marrow Mononuclear Cell Transplantation
- Where
- Vietnam
- Volunteers
- 60 people
- Sponsor
- National Children's Hospital, Vietnam
Acute Liver Failure, Hepatic Encephalopathy
N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure
We have completed patient enrollment in the the double blind, randomized, placebo-controlled trial of intravenous (IV) N-acetylcysteine (NAC) vs. placebo for the treatment of non-acetaminophen ALF.
- Trial name
- NCT00248625
- Testing
- N-acetylcysteine
- Where
- 20 sites in United States, Canada and 1 more
- Volunteers
- 184 people
- Sponsor
- University of Pittsburgh
Neonatal Encephalopathy
Uterine Activity in Moderate-Severe Neonatal Encephalopathy: A Case Control Study
Excessive uterine activity may be one of several aetiological factors that contribute to depressed neurological function in the newborn.
- Trial name
- NCT03122808
- Testing
- Uterine Activity Analysis, Partogram Analysis
- Where
- Ireland
- Volunteers
- 264 people
- Sponsor
- The Rotunda Hospital
Cerebral Visual Impairment, Refractive and Accommodative Disorders
Babies in Glasses; a Feasibility Study.
This is a feasibility study to begin investigating the possibility that early use of near vision glasses will improve vision in infants at risk of Cerebral Visual Impairment (CVI), leading to further improvement in other areas of…
- Conditions
- Cerebral Visual Impairment, Refractive and Accommodative Disorders, Hypoxic-Ischemic Encephalopathy, Premature Birth
- Trial name
- BiG (NCT05048550)
- Testing
- Near vision spectacles
- Where
- United Kingdom
- Volunteers
- 55 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
Urea Cycle Disorder, Organic Acidemia
Systemic Biomarkers of Brain Injury From Hyperammonemia
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…
- Conditions
- Urea Cycle Disorder, Organic Acidemia, Maple Syrup Urine Disease, Glutaric Acidemia I
- Trial name
- NCT04602325
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Children's National Research Institute
Hypothermia
Pharmacokinetics of Ampicillin in Neonates With Moderate to Severe Hypoxic-Ischemic Encephalopathy
Controlled Hypothermia has become the standard of care for neonates with moderate to severe HIE. Ampicillin and aminoglycosides are drugs that are universally used for the treatment of suspected neonatal sepsis, which may or may…
- Trial name
- NCT03129620
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Drexel University
CSWS, Developmental and/or Epileptic Encephalopathies
Melatonin for the Treatment of DEE-SWAS
The goal of this study is to learn if melatonin, a naturally produced substance, can help to treat some of the symptoms of DEE-SWAS, a type of epilepsy that causes children to lose skills and development.
- Conditions
- CSWS, Developmental and/or Epileptic Encephalopathies, Electrical Status Epilepticus in Sleep
- Trial name
- NCT07221968
- Testing
- Melatonin
- Volunteers
- 3 people
- Sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Hypoxic-Ischemic Encephalopathy
RIC in HIE: A Safety and Feasibility Trial
Remote Ischemic Conditioning has never been studied in neonates with HIE. However, RIC has been studied in animal models of perinatal asphyxia and has shown encouraging results.
- Trial name
- NCT05379218
- Testing
- Remote Ischemic Conditioning
- Where
- Canada
- Volunteers
- 32 people
- Sponsor
- The Hospital for Sick Children
Status Epilepticus, Altered Level of Consciousness
eegCap Application in Paediatrics wiTh redUced GCS in REsus
Children frequently present with altered or reduced consciousness levels to emergency departments. By using EEG monitoring, subclinical seizure activity may be detected, leading to earlier pharmacological intervention and…
- Conditions
- Status Epilepticus, Altered Level of Consciousness, Non-epileptic Seizures, Epilepsy
- Trial name
- CAPTURE (NCT05259891)
- Where
- Ireland
- Volunteers
- 20 people
- Sponsor
- University College Cork
Hypoxic-Ischemic Encephalopathy
A Study of a Blood Marker in Newborns With Brain Injury Caused by Lack of Oxygen at Birth
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.
- Trial name
- NCT07292220
- Where
- Turkey (Türkiye)
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Mustafa Gürkan
SCN8A Developmental and Epileptic Encephalopathy Syndrome
Extension Study to Evaluate How Safe and Tolerable NBI-921352 is as an Adjunctive Therapy for Participants With SCN8A-DEE
Extension study to evaluate how safe and tolerable the drug NBI-921352 is when used as adjunctive therapy in participants with SCN8A developmental and epileptic encephalopathy syndrome (SCN8A-DEE).
- Trial name
- NCT05226780
- Testing
- NBI-921352
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Neurocrine Biosciences
Hypoxic-Ischemic Encephalopathy
Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy
Citicoline, is a naturally occurring compound and an intermediate in the metabolism of phosphatidylcholine. Phosphatidylcholine is an important component of the phospholipids of the cell membranes.
- Trial name
- citicoline (NCT03181646)
- Testing
- citicoline
- Where
- Pakistan
- Volunteers
- 50 people
- Sponsor
- Armed Forces Hospital, Pakistan
Cardiac Arrest
Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial
Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in which the body's temperature is lowered and maintained several degrees below normal for a period of time, has been used to successfully…
- Trial name
- THAPCA-IH (NCT00880087)
- Testing
- Therapeutic Hypothermia, Therapeutic Normothermia
- Where
- 33 sites in United States, Canada and 1 more
- Volunteers
- 329 people
- Sponsor
- University of Michigan
Dravet Syndrome
A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet Syndrome
The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of ZX008 (fenfluramine hydrochloride) when added to adjunctive antiepileptic stiripentol treatment in children and young adults with Dravet…
- Trial name
- NCT02926898
- Testing
- ZX008 (Fenfluramine Hydrochloride)
- Where
- 28 sites in United States, Canada and 5 more
- Volunteers
- 87 people
- Sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Hypoxic-Ischemic Encephalopathy, Brain Injury
Prospective Research in Infants With Mild Encephalopathy
A multicenter observational pilot study will be conducted to determine the natural history of infants with early diagnosis (≤ 6 hrs of age) of mild neonatal encephalopathy (NE) who are not qualified for therapeutic hypothermia.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Brain Injury, Neonatal Seizure
- Trial name
- PRIME (NCT01747863)
- Testing
- Neurologic examination
- Where
- 7 sites in United States, Canada and 2 more
- Volunteers
- 63 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre