Clinical trials: Hypoxic-Ischemic Encephalopathy
Infant, Newborn, Hypoxia, Brain
Late Hypothermia for Hypoxic-Ischemic Encephalopathy
This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ≥ 36 weeks gestational age with…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT00614744
- Testing
- Hypothermia, Normothermic Control
- Where
- 22 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
Hypoxic-Ischemic Encephalopathy
Dose Optimization of Caffeine for HIE
This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.
- Trial name
- NCT06448780
- Testing
- Caffeine citrate 20 mg/kg, Caffeine citrate 30 mg/kg
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- University of North Carolina, Chapel Hill
Hypoxic Ischemic Encephalopathy, Perinatal Asphyxia
Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy
Oxygen radicals and inflammation are important causes for brain injury in neonates following perinatal asphyxia. Animal studies demonstrated potential benefits to the brain when using both of vitamin C and ibuprofen.
- Trial name
- NCT00624871
- Testing
- Ascorbic acid (vitamin C), Ibuprofen
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Al-Azhar University
Post-Resuscitation Syndrome, Critical Illness
Predicting Mortality in Patients With Return of Spontaneous Circulation After Cardiac Arrest
This retrospective observational cohort study aims to identify early predictors of short- and mid-term mortality in adult patients who achieved return of spontaneous circulation (ROSC) after cardiac arrest.
- Conditions
- Post-Resuscitation Syndrome, Critical Illness, Cardiac Arrest, Hypoxic-Ischemic Encephalopathy
- Trial name
- PROM-ROSC (NCT07020091)
- Where
- Turkey (Türkiye)
- Volunteers
- 168 people
- Sponsor
- Ahmet Düzgün
Severe Hypoxic Ischemic Encephalopathy, Moderate Hypoxic Ischemic Encephalopathy
Efficacy Study of Hypothermia Plus Magnesium Sulphate(MgSO4) in the Management of Term and Near Term Babies With Hypoxic Ischemic Encephalopathy
The purpose of this study is to assess whether the addition of a drug such as Magnesium sulphate while providing therapeutic hypothermia (or cooling) to babies who are asphyxiated at birth provides additional benefit to the…
- Trial name
- MagCool (NCT01646619)
- Testing
- Magnesium Sulphate
- Where
- 7 sites in Egypt, Malaysia and 4 more
- Volunteers
- 300 people
- Sponsor
- Sajjad Rahman
Brain Ischemia Hypoxia, Muscle; Ischemic
Multisite Tissue Oxygenation Guided Perioperative Care in Cardiac Surgery
The BOTTOMLINE-CS trial is an international, open, single-center, pragmatic, randomised controlled trial to investigate whether multisite tissue oxygen saturation monitoring-guided perioperative care reduces composite…
- Conditions
- Brain Ischemia Hypoxia, Muscle; Ischemic, Muscle Hypoxia
- Trial name
- BOTTOMLINECS (NCT04896736)
- Testing
- Multisite tissue oxygenation-guided care, Usual care
- Where
- China
- Volunteers
- 1,960 people
- Sponsor
- Yale University
Therapeutic Hypothermia, Neonatal Hypoxic-Ischemic Encephalopathy
Continuous Monitoring of Body Temperature in Neonates During Therapeutic Hypothermia
This prospective observational pilot study aims to evaluate the feasibility, accuracy, and safety of the SteadyTemp® wireless adhesive thermometer for continuous, non-invasive body temperature monitoring in neonates undergoing…
- Conditions
- Therapeutic Hypothermia, Neonatal Hypoxic-Ischemic Encephalopathy, Neonatal Thermal Management
- Trial name
- MonT HT (NCT07756892)
- Testing
- continous temperature measurement
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Medical University of Graz
Asphyxia Neonatorum
Asphyxia Associated Metabolite Biomarker Investigation (AAMBI)
Verification of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies.
- Trial name
- AAMBI (NCT03354208)
- Testing
- blood sampling
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- Life Science Inkubator
Hypoxia-Ischemia, Brain, Ischemia, Vertebral Artery
Oxygen Concentration and Recovery After Carotid Endarterectomy
This study evaluates effects of high inspiratory oxygen on cerebral tissue oxygenation and patient recovery after carotid endarterectomy.
- Conditions
- Hypoxia-Ischemia, Brain, Ischemia, Vertebral Artery, Artery Stenosis, Carotid
- Trial name
- NCT02991976
- Testing
- Oxygen concentration
- Where
- Croatia
- Volunteers
- 80 people
- Sponsor
- Osijek University Hospital
Hypoxic-Ischemic Encephalopathy
Clinical Trial of a New Rectum Cooling System on Patients of Hypoxic-ischemic Brain Damage
This study will try to evaluate the effectiveness and safety of a new method for achieving mild hypothermia, i.e.,mild hypothermia therapy through rectum.
- Trial name
- NCT02544542
- Testing
- Rectum cooling system, Hyper-hypothermia blanket
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Children's Hospital of Chongqing Medical University
Neonatal Encephalopathy
Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia
Around the time of birth, some babies experience a condition called asphyxia, which means that their brain and other organs do not receive enough blood and/or oxygen to work properly.
- Trial name
- NCT06098833
- Testing
- Sildenafil, Ora-Blend
- Where
- 3 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Pia Wintermark
Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy
The Impact of Holding on Stress and Bonding in Mother-Infant Pairs During Therapeutic Hypothermia
This research is being done to try to improve the experience of mothers and babies during therapeutic hypothermia. Currently, mothers are not able to hold their baby during hypothermia treatment.
- Trial name
- NCT03837717
- Testing
- Holding, Saliva collection, No Holding
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- MaineHealth
Epilepsy, Dravet Syndrome
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.
- Conditions
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- Trial name
- ELEKTRA (NCT03650452)
- Testing
- TAK-935
- Where
- 44 sites in United States, Australia and 6 more
- Volunteers
- 141 people
- Sponsor
- Takeda
HIE - Hypoxic - Ischemic Encephalopathy
COMPARISON OF OUTCOME OF HYPOXIC ISCHEMIC ENCEPHLOPATHY MANAGED WITH COMBINATION OF MAGNESIUM SULPHATE AND MELATONIN VERSUS MAGNESIUM SULPHATE ALONE
COMPARISON OF OUTCOME OF HYPOXIC ISCHEMIC ENCEPHALOPATHY MANAGED WITH COMBINATION OF MAGNESIUM SULPHATE AND MELATONIN VERSUS MAGNESIUM SULPHATE ALONE Participants of group A will have 3 doses of MgSO4 infusion at rate of 250mg/kg…
- Trial name
- NCT07652801
- Testing
- MgSO4 (seizure prevention), Melatonin , Mgso4
- Volunteers
- 80 people
- Sponsor
- University of Child Health Sciences and Children's Hospital, Lahore
Hypoxic-Ischemic Encephalopathy, Bronchopulmonary Dysplasia
Efficacy Evaluation of UCB-MNCs in the Treatment of Refractory Neonatal Diseases
Hypoxic-ischemic encephalopathy (HIE), bronchopulmonary dysplasia (BPD), short bowel syndrome (SBS) are refractory in clinical treatment.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Bronchopulmonary Dysplasia, Short Bowel Syndrome
- Trial name
- NCT06427642
- Testing
- Mononuclear cells, Mild hypothermia therapy, Breathing support technique
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shandong Qilu Stem Cells Engineering Co., Ltd.
Hypoxic-Ischemic Encephalopathy
Holding, Stress, and Bonding During Therapeutic Hypothermia
Ten infants undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy will be enrolled in a new protocol that will allow mothers to hold their infants during the hypothermia treatment period.
- Trial name
- NCT03079284
- Testing
- Holding during cooling
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Alexa Craig
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
Hypoxic-Ischemic Encephalopathy
The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation in Neonates With HIE
The goal of this clinical trial is to evaluate the effects of minimal enteral nutrition (MEN) on mesenteric blood flow and oxygenation with Doppler USG and Near Infrared Spectroscopy (NIRS) during therapeutic hypo¬thermia (TH) in…
- Trial name
- NCT06344286
- Testing
- Minimal enteral nutrition, Distilled water
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Istanbul Training and Research Hospital
Cardiac Arrest, Inflammation
Immunoinflammatory Response in Post Cardiac Arrest Syndrome (PCAS)
This is a prospective, observational study to investigate molecular mechanisms mediating the systemic inflammatory process, and changes to metabolism, and their impact on brain injury, survival, and functional outcomes after…
- Conditions
- Cardiac Arrest, Inflammation, Obesity, Hypoxic Ischemic Encephalopathy (HIE)
- Trial name
- PCAS (NCT02664831)
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- MaineHealth
Neonatal Hypoxic Ischemic Encephalopathy
Prognostic Value of Arterial Spin Labeling Brain Perfusion MRI in Term Neonates With Hypoxic-ischemic Encephalopathy
The main purpose of this study will be to evaluate the prognostic value at 3 months of life of brain perfusion MRI determined by Arterial Spin Labeling technique in the first week of life of term newborns with hypoxic-ischemic…
- Trial name
- BBASL (NCT04325230)
- Testing
- Arterial Spin Labeling sequence
- Where
- France
- Volunteers
- 31 people
- Sponsor
- University Hospital, Bordeaux