Clinical trials: Neonatal Encephalopathy
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
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, Birth Asphyxia
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries
The investigators will conduct a study on non-vigorous infants at birth to determine if umbilical cord milking (UCM) results in lower rate of moderate to severe hypoxic ischemic encephalopathy (HIE) or death than early clamping…
- Trial name
- CORDMILK (NCT03657394)
- Testing
- Umbilical cord milking
- Where
- 9 sites in India
- Volunteers
- 3,442 people
- Sponsor
- Nemours Children's Clinic
Refractory Epilepsy, SYNGAP1 Encephalopathy
Fenfluramine for the Treatment of Different Types of Developmental and Epileptic Encephalopathies: a Pilot Trial Exploring Epileptic and Non-epileptic Outcomes
This study is a pilot non-controlled clinical trial with adjunctive fenfluramine for the treatment of five different types of developmental and epileptic encephalopathies (DEEs) focused on epileptic and "non-epileptic outcomes"…
- Conditions
- Refractory Epilepsy, SYNGAP1 Encephalopathy, STXBP1 Encephalopathy With Epilepsy, Inv Dup(15) Encephalopathy
- Trial name
- FENDEEP (NCT05232630)
- Testing
- Fenfluramine
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Hospital Ruber Internacional
Hypoxic Encephalopathy
Early Neurological Outcome in Newborns With Mild Encephalopathy:a Regional Network
This is a multicenter prospective observational study that aims to determine the natural history of patients with early diagnosis (within 6 hours of life) of mild hipoxic ischemic encephalopaty (HIE), who are not candidates for…
- Trial name
- NCT05785481
- Testing
- Clinical and instrumental neurological assessment
- Where
- Italy
- Volunteers
- 27 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Hypoxic-Ischemic Encephalopathy, Asphyxia
Hydrocortisone Treatment In Systemic Low Blood Pressure During Hypothermia in Asphyxiated Newborns
This is a prospective, randomized, double-blind, placebo controlled, single center study to compare low dose hydrocortisone vs placebo in systemic low blood pressure during hypothermia treatment in asphyxiated newborns.
- Trial name
- CORTISoL (NCT02700828)
- Testing
- Hydrocortisone
- Where
- Hungary
- Volunteers
- 32 people
- Sponsor
- Semmelweis University
Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy
Nephroprotection Following Perinatal Asphyxia: Randomized Controlled Trial
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…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy, Pentoxifylline Adverse Reaction
- Trial name
- NCT07088328
- Testing
- Pentoxifylline
- Volunteers
- 30 people
- Sponsor
- Alexandria University
Genetic Disease, STXBP1 Encephalopathy With Epilepsy
STXBP1 and SYNGAP1 Related Disorders Natural History Study
The purpose of this study is to find out more about STXBP1 and SYNGAP1 related disorders. The information gathered by this study will be used to prepare for clinical treatment trials.
- Conditions
- Genetic Disease, STXBP1 Encephalopathy With Epilepsy, SYNGAP1-Related Intellectual Disability
- Trial name
- NCT06555965
- Testing
- Non-interventional study
- Where
- 5 sites in United States
- Volunteers
- 600 people
- Sponsor
- Children's Hospital of Philadelphia
Hypoxic Ischaemic Encephalopathy (HIE)
EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES
To compare the survival rate and improvement in stage of hypoxic ischemic encephalopathy (HIE) at day 7 of treatment in neonates treated with versus without melatonin in addition to standard supportive therapy.
- Trial name
- NCT07305350
- Testing
- Melatonin, intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover
- Where
- Pakistan
- Volunteers
- 110 people
- Sponsor
- University of Child Health Sciences and Children's Hospital, Lahore
Hypoxic-Ischemic Encephalopathy
School-aged Outcomes Post Hypoxic Ischaemic Encephalopathy
Neonatal HIE increases the risk for cognitive impairments in childhood. Neonatal MRI brain scans are a strong predictor for outcome, however a normal scan has only a 35% sensitivity and 85% specificity for a normal outcome.
- Trial name
- SOPHIE (NCT07770035)
- Where
- Ireland
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- University College Cork
Periventricular Leukomalacia, White Matter Disease
Cell-Based Therapy for White Matter Repair in Periventricular Leukomalacia
The goal of this study is to explore a new treatment that may help repair brain damage in individuals with periventricular leukomalacia (PVL), a condition that affects white matter in the brain.
- Conditions
- Periventricular Leukomalacia, White Matter Disease, Hypoxic-Ischemic Encephalopathy, Demyelinating Diseases
- Trial name
- NCT06985303
- Testing
- Investigational Combination Product
- Sponsor
- MGAM LLC
Neonates With HIE
Magnesium Sulfate in Neonatal HIE"
The study will investigates the neuroprotective effects of intravenous magnesium sulfate in neonates with hypoxic-ischemic encephalopathy (HIE) at a Karachi tertiary care hospital.
- Trial name
- NCT06342362
- Testing
- Magnesium sulfate
- Where
- Pakistan
- Volunteers
- 102 people
- Sponsor
- Sindh Institute of Child Health and Neonatology
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
Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy
PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia
A phase 1 study investigating the tolerability and pharmacokinetics of caffeine citrate in neonates with hypoxic ischemic encephalopathy receiving therapeutic hypothermia.
- Conditions
- Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Caffeine
- Trial name
- NCT05295784
- Testing
- Caffeine citrate
- Where
- 2 sites in United States
- Sponsor
- University of Arkansas
Hypoxic-Ischemic Encephalopathy
Erythropoietin in Management of Neonatal Hypoxic Ischemic Encephalopathy
Perinatal hypoxic-ischaemic encephalopathy occurs in one to three infants per 1000 term births, and up to 12 000 infants are affected each year in the united state of America.
- Trial name
- NCT03163589
- Testing
- Erythropoietin, normal saline
- Volunteers
- 40 people
- Sponsor
- Assiut University
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
AMPD3, OMIM*102772, AMP Deaminase Deficiency, AK1, OMIM *103000, Adenylate Kinase Deficiency
A Natural History Study Seeks to Understand the Clinical, Genomic, Pharmacological, Laboratory, and Dietary Determinates of Pyrimidine and Purine Metabolism Disorders
Background: Pyrimidine and purine metabolism disorders (DPPMs) affect how the body metabolizes chemicals called pyrimidines and purines.
- Conditions
- AMPD3, OMIM*102772, AMP Deaminase Deficiency, AK1, OMIM *103000, Adenylate Kinase Deficiency, AMPD1, OMIM *102770, Myopathy Due to Myoadenylate Deaminase Deficiency, TPMT, OMIM *187680, Thoipurines, Poor Metabolism of
- Trial name
- NCT06092346
- Where
- United States
- Volunteers
- 999 people
- Sponsor
- National Human Genome Research Institute (NHGRI)
Hypoxia-Ischemia, Brain
The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy
The purpose of this study is to evaluate the safety and the tolerability of CL2020 cells in hypoxic ischemic encephalopathy neonates with hypothermia therapy.
- Trial name
- SHIELD (NCT04261335)
- Testing
- CL2020 cells
- Where
- Japan
- Volunteers
- 9 people
- Sponsor
- Nagoya University
Moderate to Severe Hypoxic-ischemic Encephalopathy
Study of hCT-MSC in Newborn Infants With Moderate or Severe HIE
To determine the safety of single and repeated intravenous doses of hCT-MSC in newborn infants with HIE.
- Trial name
- NCT03635450
- Testing
- Infusion of hCT-MSC
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Joanne Kurtzberg, MD
Mitochondrial Encephalomyopathies, Hereditary Spastic Paraplegia
Natural History Study of Patients with HPDL Mutations
This study uses medical records that allow retrospective data extraction of clinical manifestation to assess the natural history of HPDL mutations
- Conditions
- Mitochondrial Encephalomyopathies, Hereditary Spastic Paraplegia, Spastic Paraplegia, White Matter Disease
- Trial name
- NCT05848271
- Testing
- Patient Registry, Dry blood spots sampling
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Diego