Clinical trials: Hypoxic-Ischemic 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
Cerebral Ischemia-Hypoxia
Effect of Sedatives on Regional Cerebral Oxygen Saturation
Compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine sedation for spinal anesthesia in the elderly patients who undergoing femur surgery.
- Trial name
- 2 (NCT02966743)
- Testing
- Midazolam, Dexmedetomidine
- Where
- South Korea
- Sponsor
- Gachon University Gil Medical Center
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
Perinatal Stroke, Hypoxic-ischemic Encephalopathy
Protein Supplementation in Infants With Brain Injury
To date, few studies have been done regarding nutrition supplementation in infants with brain injury. Therefore, the investigators are proposing to study the effects of protein supplementation in this group of babies.
- Conditions
- Perinatal Stroke, Hypoxic-ischemic Encephalopathy, White Matter Injury
- Trial name
- NCT01936246
- Testing
- Increased protein
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Anoxic Brain Injury
Safety and Efficacy Assessment of Autologous Bone-marrow Derived Adult Mesenchymal Stem Cell Therapy in Patients With Anoxic(or Hypoxic) Brain Injury Pilot Trial
The purpose of study is to evaluate the safety and efficacy of autologous bone marrow-derived stem cells therapy in patients with anaerobic (hypoxic) brain injury.
- Trial name
- NCT02210624
- Testing
- HYNR-CS inj.
- Where
- South Korea
- Volunteers
- 4 people
- Sponsor
- Hyun Young Kim
Hypoxic Ischaemic Encephalopathy
Xenon and Cooling Therapy in Babies at High Risk of Brain Injury Following Poor Condition at Birth
This study examines the effect of inhaled xenon gas in the treatment of newborn infants with hypoxic-ischemic encephalopathy (HIE) in combination with cooling, which is the standard treatment for this condition.
- Trial name
- CoolXenon3 (NCT02071394)
- Testing
- Xenon gas, Whole body cooling
- Where
- 2 sites in United Kingdom
- Volunteers
- 50 people
- Sponsor
- University Hospitals Bristol and Weston NHS Foundation Trust
Hypoxic-Ischemic Encephalopathy, Neonatal, Brain Injuries, Hypoxic-Ischemic
Mesenchymal Stem Cells With Cooling Therapy for Infants With Hypoxic-Ischemic Encephalopathy
Hypoxic-ischemic encephalopathy (HIE) is a serious condition in newborns caused by lack of oxygen and blood flow around the time of birth.
- Trial name
- SiSTEM-NEO (NCT07018739)
- Testing
- Wharton's jelly-derived mesenchymal stem cells, 0.9 % Normal Saline
- Where
- Thailand
- Volunteers
- 40 people
- Sponsor
- Mahidol University
Hypoxic-Ischemic Encephalopathy, Post-Cardiorespiratory Arrest Coma
Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia
This study is designed to assess the effect of cerebral oxygen saturation as an early predictor of neurological outcomes in patients undergoing therapeutic hypothermia after cardiac arrest
- Conditions
- Hypoxic-Ischemic Encephalopathy, Post-Cardiorespiratory Arrest Coma, Cardiac Arrest
- Trial name
- NCT03024021
- Testing
- Near-infrared spectroscopy (NIRS) (INVOS®, Covidien)
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Tepecik Training and Research Hospital
Traumatic Coma
Brain Network Disruptions Related to Traumatic Coma
To provide a fine-grained description of the brain network dysfunctions induced by severe traumatic brain injury (TBI) or anoxic encephalopathy, that are responsible for the acute state of unarousable unawareness, named coma…
- Trial name
- Coma3D (NCT03482115)
- Testing
- PET examination with radiopharmaceutical drug [18F] DPA-714, MRI examination, Blood samples
- Where
- France
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- University Hospital, Toulouse
Neurologic Disorder, Disorder of Consciousness
Prognostic Factors to Regain Consciousness
The study aims to identify factors that predict the medium and long-term outcome of patients with disorders of consciousness (DOC) undergoing early neurological rehabilitation.
- Conditions
- Neurologic Disorder, Disorder of Consciousness, Traumatic Brain Injury, Stroke
- Trial name
- NCT04445649
- Testing
- Coma-Recovery-Scale-Revised (CRS-R)
- Where
- Germany
- Volunteers
- 130 people
- Sponsor
- BDH-Klinik Hessisch Oldendorf
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
Hypoxic-Ischemic Encephalopathy
Developmental Outcomes
Determine whether the concentrations of UCH-L1 and GFAP measured in umbilical cord blood and in blood 0-6 hours postnatal accurately predict the extent of neurodevelopmental deficits and/or death at 18-20 months.
- Trial name
- NCT02264808
- Testing
- Developmental Outcomes
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Florida
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
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
Circulatory Failure
NeoAdapt 3: Novel Biomarkers in the Evaluation of Neonatal Circulatory Insufficiency in Babies Suffering From Hypoxic Ischemic Encephalopathy
1 in 1000 babies are born suffering from a lack of oxygen. This is known as hypoxic ischemic encephalopathy (HIE). Infants with this condition can suffer multiple organ problems.
- Trial name
- NCT02051894
- Testing
- Dobutamine
- Where
- United Kingdom
- Volunteers
- 18 people
- Sponsor
- Brighton and Sussex University Hospitals NHS Trust
HIE, Hypoxic-Ischemic Encephalopathy
Hydrogen In Neonatal Encephalopathy (HIE) Trial
Despite advances in neonatal care, moderate-to-severe acute perinatal HIE in late preterm and term infants remains a cause of mortality, neurological injury, and long-term neurodevelopmental disability.
- Trial name
- NCT07411911
- Testing
- Hydrogen Gas (H2)
- Volunteers
- 54 people
- Sponsor
- Boston Children's Hospital
Hypoxic Ischemic Encephalopathy
Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy
The hypothesis is that premature infants' can have enough cooling applied to cool their brain to decrease CNS injury without cooling their body.
- Trial name
- NCT00620711
- Testing
- Olympic Cool Cap
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Vanderbilt University
Cardiac Arrest, Hypoxic Ischemic Brain Injury
TIBOHCA: Safety, Tolerability and Pharmacokinetics of 2-Iminobiotin (2-IB) After OHCA
Following successful cardiopulmonary resuscitation (CPR) after out of hospital cardiac arrest (OHCA), 50% of patients admitted to the Intensive Care Unit (ICU) die.
- Trial name
- TIBOHCA (NCT02836340)
- Testing
- 2-Iminobiotin
- Where
- Netherlands
- Volunteers
- 21 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Seizures
Pilot Study of Bumetanide for Newborn Seizures
The main goal of the study is to obtain pharmacokinetic and safety data of bumetanide in newborns with refractory seizures. The overall hypothesis is that bumetanide, added to conventional antiepileptic (antiseizure) medications…
- Trial name
- NCT00830531
- Testing
- Bumetanide
- Where
- 4 sites in United States
- Volunteers
- 43 people
- Sponsor
- Soul, Janet , M.D.
Hypoxic-Ischemic Encephalopathy, Congenital Heart Disease
Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit
The wireless NIRS sensor will be placed on the participant's forehead, directly underneath the INVOS wired sensor. The wireless NIRS sensor will remain in place for 4 consecutive hours, over 2 consecutive days.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Congenital Heart Disease, Stroke Hemorrhagic, Aneurysm Cerebral
- Trial name
- NCT07732244
- Testing
- Wireless NIRS
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre