Clinical trials: Hypoxic Ischemic Brain Injury, active
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
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
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
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
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
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
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
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
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
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
Traumatic Brain Injury, Cerebral Palsy
Real World Outcomes of Intranasal MuSE Exosomes and Stem Cells in Neurological Regenerative Therapy
This prospective observational study collects real world data on participants receiving regenerative therapies administered internationally and delivered intranasally via the Kurve Therapeutics ViaNase device.
- Conditions
- Traumatic Brain Injury, Cerebral Palsy, Hypoxic Ischemic Encephalopathy, Neurologic Disorders
- Trial name
- MuSE-INSIGHT (NCT07521384)
- Where
- Mexico
- Volunteers
- 36 people
- Sponsor
- Healing Hope International
Cerebrovascular Disease, Ischemic Stroke
Florida Cerebrovascular Disease Biorepository and Genomics Center
The purpose of this study is to create a state-wide biorepository and resource center for cerebrovascular diseases in Florida, which will include collecting medical history information and blood from subjects affected by…
- Conditions
- Cerebrovascular Disease, Ischemic Stroke, Transient Ischemic Attack, Intracerebral Hemorrhage
- Trial name
- NCT05491980
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Mayo Clinic
Hypoxic Ischemic Encephalopathy of Newborn, Hypoxic Ischemic Encephalopathy
The HIEnome Study: Genome Sequencing for Perinatal HIE
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.
- Conditions
- Hypoxic Ischemic Encephalopathy of Newborn, Hypoxic Ischemic Encephalopathy, Hypoxic Ischemic Encephalopathy (HIE)
- Trial name
- NCT06762795
- Testing
- Genome sequencing
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Baylor College of Medicine
Neonatal Seizure, Neonatal Encephalopathy
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
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…
- Conditions
- Neonatal Seizure, Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Seizure Newborn
- Trial name
- NEOLEV3 (NCT05610085)
- Testing
- Levetiracetam Injection, Phenobarbital Sodium Injection
- Where
- 6 sites in United States, New Zealand
- Volunteers
- 133 people
- Sponsor
- University of California, San Diego
Neonatal Seizures, HIE - Hypoxic - Ischemic Encephalopathy
Treatment of Seizures in Neonate With HIE
Aim of the study To evaluate and compare phenobarbital's and levetiracetam's safety and efficacy for treating seizures in neonates with moderate to severe HIE
- Trial name
- HIE (NCT07284498)
- Testing
- Phenobarbital, Levetiracetam
- Where
- 2 sites in Egypt
- Volunteers
- 66 people
- Sponsor
- Mansoura University
Neonatal Encephalopathy
Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonatal Encephalopathy
The aim of our study is to evaluate the feasibility of applying transcutaneous CO2 monitoring (tcPCO2) in neonates receiving therapeutic hypothermia and to quantify the agreement between tcPCO2 and PCO2 in this population with or…
- Trial name
- NCT04603547
- Testing
- Transcutaneous Carbon Dioxide Monitoring
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Brigham and Women's Hospital
Hypoxic-Ischemic Encephalopathy
Sildenafil Plus Hypothermia to Treat Neonatal Encephalopathy
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.
- Trial name
- SHINE1 (NCT06810284)
- Testing
- Sildenafil Citrate (IV)
- Where
- France
- Volunteers
- 24 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy
Dexmedetomidine Versus Morphine During Cooling Therapy in Neonates
About ~3/ 1000 live-born newborns may suffer from brain injury due to a transient drop in oxygen supply to the brain during the birth process.
- Conditions
- Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy, Perinatal Anoxic-ischemic Brain Injury
- Trial name
- COOL-SED (NCT06985290)
- Testing
- Dexmedetomidine Infusion, Morphine Infusion
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Ipsita Goswami
Acute Brain Injury, Traumatic Brain Injury
Bedside Cranial Ultrasound for Risk-Stratified Imaging in Pediatric Acute Brain Injury
Acute brain injury (ABI) is a leading cause of death and long-term disability in children. Diagnosis depends on fast neuroimaging, and head computed tomography (CT) is the bedside reference standard despite exposing the…
- Conditions
- Acute Brain Injury, Traumatic Brain Injury, Intracranial Hemorrhage, Hydrocephalus
- Trial name
- CUPID-Peds (NCT07772323)
- Where
- United States
- Volunteers
- 220 people
- Sponsor
- Virginia Commonwealth University