Clinical trials: Encephalopathy, Hypoxic-Ischemic
Hypoxic Ischemic Encephalopathy
Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (Control Levels)
Hypoxic-ischemic encephalopathy (HIE) is a serious birth complication due to systemic asphyxia which occurs in about 20 of 1,000 full-term infants and nearly 60% of premature newborns.
- Trial name
- NCT02349672
- Testing
- blood sample
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- University of Florida
Hypoxic Ischemic Encephalopathy, Cerebral Infarction
Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy
This study examines the effect of cord blood in the treatment of newborn infants with neonatal encephalopathy in combination with hypothermia, which is the standard treatment for this condition.
- Trial name
- NCT02551003
- Testing
- Autologous cord blood, Hypothermia
- Where
- China
- Sponsor
- Children's Hospital of Fudan University
Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy
Neonatal Neurological Observation With Video AI
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…
- Conditions
- Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Sedation, Sleep
- Trial name
- NeoNOVA (NCT07628829)
- Testing
- Continuous bedside video monitoring with AI anatomic landmark tracking for neurologic monitoring
- Where
- 2 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Artemis AI Labs
Hypoxic-ischemic Encephalopathy
Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy
The purpose of this study is to to evaluate the safety and efficacy of hyperbaric oxygen in term gestation newborn infants with hypoxic-ischemic encephalopathy..
- Trial name
- NCT02894866
- Testing
- hyperbaric oxygen
- Where
- 10 sites in China
- Volunteers
- 250 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Mild Hypoxic Ischemic Encephalopathy of Newborn
Cool Prime Comparative Effectiveness Study for Mild HIE
To determine effectiveness of therapy to improve neurodevelopmental outcomes in infants with mild HIE. To determine the adverse effects of Therapeutic Hypothermia (TH) in mild HIE on the neonate and his/her family.
- Trial name
- COOLPRIME (NCT04621279)
- Testing
- Normothermia, Whole body therapeutic hypothermia
- Where
- United States
- Volunteers
- 460 people
- Sponsor
- University of Texas Southwestern Medical Center
Hypoxia-Ischemia, Brain, Periventricular Leukomalacia
Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury
The investigators propose to compare the proteomic analysis of umbilical venous blood from neonates with brain injury to gestational age matched noninjured controls.
- Trial name
- NCT00375908
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Johns Hopkins University
Hypoxic Ischaemic Encephalopathy (HIE), Premature Birth
Healing Tiny Minds: Rural Recovery Through Virtual and Lived Experience Care
The goal of this behavioral-interventional study is to learn if the Abecedarian Approach implemented virtually for children ages 0-5 with a history of Hypoxic Ischaemic Encephalopathy (HIE) and/or premature birth produces the…
- Conditions
- Hypoxic Ischaemic Encephalopathy (HIE), Premature Birth, Cerebral Palsy, Neurological Disorder
- Trial name
- NCT06643598
- Testing
- Abecedarian Approach
- Where
- United States
- Volunteers
- 225 people
- Sponsor
- University of Wisconsin, Madison
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
Anoxic-Ischemic Encephalopathy
Becoming Children With Perinatal Anoxo-Ischemic Encephalopathy Without Indication of Therapeutic Hypothermia
There are 3 levels of severity of anoxo-ischemic encephalopathy (EAI): mild, moderate and severe. Therapeutic hypothermia is beneficial in children with moderate EAI.
- Trial name
- SARNATUN (NCT03744481)
- Testing
- Questionaire
- Where
- France
- Volunteers
- 68 people
- Sponsor
- Hospices Civils de Lyon
Birth Asphyxia
First-day High Dose Vitamin C, E in Severe Birth Asphyxia
To study the role of first-day high dose oral vitamin C and first-day single high dose oral vitamin E in hypoxic-ischemic encephalopathy in newborns, in the reduction of morbidity and adverse neurodevelopmental sequelae.
- Trial name
- CEBA (NCT01743742)
- Testing
- Vitamin E, Vitamin C
- Where
- India
- Volunteers
- 95 people
- Sponsor
- Sir Takhtasinhji General Hospital
Hypoxic Ischemic Encephalopathy of Newborn, Premature Birth
Metformin Treatment in Infants After Perinatal Brain Injury
A phase I study to test the feasibility and safety of treatment with metformin in infants affected by hypoxic ischemic encephalopathy (HIE) or prematurity-related brain injury
- Trial name
- NCT05590676
- Testing
- Metformin Hydrochloride
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- The Hospital for Sick Children
Asphyxia Neonatorum
Biomarkers And Neurological Outcome in Neonates 2
Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data in a human population for their…
- Trial name
- BANON2 (NCT04714775)
- Where
- 13 sites in Germany, Turkey (Türkiye)
- Volunteers
- 500 people
- Sponsor
- InfanDx AG
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 Brain Injury, Hypoxia, Brain
Portable MRI for Pediatric Hypoxic Ischemic Brain Injury
This study will evaluate the sensitivity and specificity of low field portable MRI (pMRI) for detection of hypoxic ischemic brain injuries in pediatric patients compared to clinically obtained neuroimaging to define pediatric…
- Conditions
- Acute Brain Injury, Hypoxia, Brain, Ischemia, Brain, Brain Injuries
- Trial name
- pMRI for HIBI (NCT07577336)
- Testing
- Portable MRI, Scavenged Sample Collection
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Children's Mercy Hospital Kansas City
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
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
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
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