Clinical trials: Encephalopathy
Cardiac Arrest
Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of 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-OH (NCT00878644)
- Testing
- Therapeutic Hypothermia, Therapeutic Normothermia
- Where
- 34 sites in United States, Canada
- Volunteers
- 295 people
- Sponsor
- University of Michigan
Hypoxic-Ischemic Encephalopathy
Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy
The purpose of this study is to investigate the effectiveness and safety of selective head cooling (SHC) in neonatal hypoxic-ischemic encephalopathy (HIE).
- Trial name
- NCT00890409
- Testing
- Cooling cap (YJW608-04B)
- Where
- China
- Volunteers
- 256 people
- Sponsor
- Fudan University
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
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
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
Hypoxic-Ischemic Encephalopathy, Brain Ischemia Hypoxia
CEUS Evaluation of Hypoxic Ischemic Injury
Neonates presenting with neurologic symptoms require rapid, non-invasive imaging with high spatial resolution and tissue contrast.
- Trial name
- NCT03549520
- Testing
- Sulfur hexafluoride lipid-type A microspheres
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Children's Hospital of Philadelphia
Epileptic Encephalopathy, Continuous Spike and Wave During Sleep
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
This is a phase 2, double-blind study to assess the efficacy, safety, tolerability, and pharmacokinetics of NBI-827104 when administered once daily for 13 weeks in pediatric subjects with Epileptic Encephalopathy with Continuous…
- Trial name
- NCT04625101
- Testing
- NBI-827104
- Where
- 15 sites in United States, Canada and 4 more
- Volunteers
- 24 people
- Sponsor
- Neurocrine Biosciences
Hypoxic Ischemic Encephalopathy
Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
The goal is to see whether topiramate (an anti-epileptic agent) improves the outcome of babies with neonatal hypoxic encephalopathy who are receiving whole body cooling.
- Trial name
- NCT01765218
- Testing
- Topiramate
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Kristin R Hoffman
Minimal Hepatic Encephalopathy
Study of Lactulose in Children With Chronic Liver Disease
Pediatric patients with chronic liver disease may have Minimal Hepatic Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological function.By utilizing cognitive and developmental testing we will…
- Trial name
- MHE (NCT00811434)
- Testing
- Lactulose
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Indiana University
Infantile Neronal Ceroid Lipofuscinosis
Cystagon to Treat Infantile Neuronal Ceroid Lipofuscinosis
This study will examine the effectiveness of a drug called Cystagon in treating infantile neuronal ceroid lipofuscinosis (INCL), a progressive neurological disease affecting children.
- Trial name
- NCT00028262
- Testing
- Cystagon
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Hypoxic Ischemic Encephalopathy
California Transport Cooling Trial
Hypoxic ischemic encephalopathy (HIE) remains a major cause of death and severe disability despite advances in neonatal and perinatal medicine. Therapeutic hypothermia is the single most promising intervention for HIE.
- Trial name
- CTCT (NCT01683383)
- Testing
- Device (servo-regulated cooling), Control (standard practice)
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Stanford University
Head Injury
Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury
The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial…
- Trial name
- NCT01824589
- Testing
- -7 cm H2O ITPR, -12cm H2O ITPR
- Volunteers
- 1 people
- Sponsor
- Advanced Circulatory Systems
Encephalopathy, Hypoxic-Ischemic
Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia
This research is being done to find out the safety of the investigational study drug, Clonidine Hydrochloride ( CLON). , in infants who are undergoing whole body cooling for the treatment of hypoxic ischemic encephalopathy (HIE).
- Trial name
- HIE (NCT01862250)
- Testing
- Clonidine (Duraclon®)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Johns Hopkins University
Hyperbilirubinemic Encephalopathy
Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries
The investigators hypothesize that a new BIND (Bilirubin Induced Neurologic Dysfunction) scoring method adapted for the developing world (BIND II, developed by our team for use by health care workers), with additional…
- Trial name
- NCT01754688
- Where
- Nigeria
- Volunteers
- 624 people
- Sponsor
- University of Minnesota
CDKL5 Deficiency Disorder
Study of Adjunctive Ganaxolone Treatment in Children and Young Adults With CDKL5 Deficiency Disorder
A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in children and young adults with genetically confirmed CDKL5 gene mutation.
- Trial name
- Marigold (NCT03572933)
- Testing
- ganaxolone
- Where
- 36 sites in United States, Australia and 6 more
- Volunteers
- 101 people
- Sponsor
- Marinus Pharmaceuticals
Neonatal Encephalopathy
CoolCap Followup Study-Coordination of Participating Centers
This observational study will assess long-term functional outcome of survivors from neonatal encephalopathy who were previously treated with either head cooling or with conventional care in a randomized clinical trial.
- Trial name
- NCT00581581
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- University of Rochester
Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns
A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy
This study will test the safety and efficacy of an infusion of a baby's own (autologous) umbilical cord blood as compared with placebo in babies born with history and signs of hypoxic-ischemic brain injury.
- Trial name
- (HIE) (NCT02612155)
- Testing
- Infusion of autologous cord blood
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Michael Cotten
Hypoxic-Ischemic Encephalopathy
Caffeine for Hypoxic-Ischemic Encephalopathy
Hypoxic-ischemic encephalopathy (HIE) due to perinatal asphyxia is common and often fatal. Therapeutic hypothermia reduces mortality and morbidity in infants with HIE.
- Trial name
- NCT03913221
- Testing
- Caffeine Citrate 5 mg/kg, Caffeine Citrate 10 mg/kg
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of North Carolina, Chapel Hill