Clinical trials: Hypoxic-Ischemic Encephalopathy
Hypoxic Ischemic Encephalopathy
Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia
Hypoxic-Ischemic Encephalopathy (HIE) occurs in 20 per 1000 births. Only 47% of neonates treated with the state of the art therapy (induced systemic hypothermia) have normal outcomes.
- Trial name
- NCT02621944
- Testing
- Melatonin, Magnetic Resonance Imaging, Pharmacokinetics
- Where
- 2 sites in United States
- Volunteers
- 70 people
- Sponsor
- University of Florida
Cardiac Arrest (CA), Anoxic Brain Injury
Early WAKE-up Predictors After Out-of-Hospital Cardiac Arrest
WAKE-OHCA is a prospective observational substudy of the Danish Out-of-Hospital Cardiac Arrest (DANOHCA) trial, identifier NCT05895838.
- Conditions
- Cardiac Arrest (CA), Anoxic Brain Injury, Comatose Survivors of Cardiac Arrest, EEG
- Trial name
- WAKE-OHCA (NCT06979700)
- Testing
- Automated Pupillometry, Transcranial Doppler Ultrasound, Optic Nerve Sheath Diameter
- Where
- 2 sites in Denmark
- Volunteers
- 250 people
- Sponsor
- University of Aarhus
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
Mechanical Ventilator Weaning, Acute Brain Injury
Brain-injured Patients Extubation Readiness Study
The BIPER study is a stepped wedge cluster randomised clinical trial aiming to decrease extubation failure in critically-ill brain-injured patients with residual impaired consciousness using a simple clinical score.
- Conditions
- Mechanical Ventilator Weaning, Acute Brain Injury, Altered Level of Consciousness, Mechanical Ventilation
- Trial name
- Biper (NCT04080440)
- Testing
- Extubation readiness clinical score, Usual Care
- Where
- 21 sites in France
- Volunteers
- 660 people
- Sponsor
- University Hospital, Clermont-Ferrand
Hypoxic-Ischemic Encephalopathy Mild
Predictive Value of aEEG and Cerebral Oxygenation on Neurological Outcomes in Newborns With Mild Hypoxic-Ischemic Encephalopathy
Newborns with mild hypoxic-ischemic encephalopathy usually do not receive cooling treatment. However, some of these newborns may develop neurological problems later in life.
- Trial name
- NCT07393620
- Where
- 3 sites in Turkey (Türkiye)
- Volunteers
- 30 people
- Sponsor
- Uludag University
Hypoxic Ischemic Encephalopathy
Safety and Efficacy of Topiramate in Neonates With Hypoxic Ischemic Encephalopathy Treated With Hypothermia
The purpose of this study is to determine whether the administration of topiramate to newborns with hypoxic-ischemic encephalopathy potentiates the neuroprotective effect of treatment with hypothermia.
- Trial name
- NeoNATI (NCT01241019)
- Testing
- Topiramate in newborns with hypoxic ischemic encephalopathy treated with therapeutic hypothermia
- Where
- 2 sites in Italy
- Volunteers
- 64 people
- Sponsor
- Meyer Children's Hospital IRCCS
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
Asphyxia Neonatorum, Neonatal Mortality
Neonatal Resuscitation in Zambia
Asphyxia is a leading cause of neonatal death in Zambia. This study will be conducted in two cities in Zambia to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to the new World…
- Conditions
- Asphyxia Neonatorum, Neonatal Mortality, Hypoxic Ischemic Encephalopathy
- Trial name
- NCT00097097
- Testing
- Neonatal Resuscitation
- Where
- Zambia
- Volunteers
- 40,000 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
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
Hypoxic Ischemic Encephalopathy of Newborn, Hyperglycemia
Continuous Glucose Monitoring in HIE
The aim of the study is to examine whether the use of continuous glucose monitoring (CGM) to guide the clinical management of glycaemic control will result into an increased time in the target glucose concentration.
- Conditions
- Hypoxic Ischemic Encephalopathy of Newborn, Hyperglycemia, Hypoglycemia
- Trial name
- NCT06563687
- Testing
- Dexcom ONE+
- Where
- 3 sites in Italy
- Volunteers
- 70 people
- Sponsor
- University of Campania Luigi Vanvitelli
Acute Kidney Injury, Hypoxia-Ischemia, Brain
Tissue Oxygenation During Treatment of Infant Congenital Heart Defects
Background: Acute kidney injury (AKI) is a common and serious postoperative complication in children with congenital heart disease.
- Conditions
- Acute Kidney Injury, Hypoxia-Ischemia, Brain, Mesenteric Ischemia
- Trial name
- NCT03941015
- Where
- China
- Volunteers
- 245 people
- Sponsor
- Beijing Anzhen Hospital
Hypoxic Ischaemic Encephalopathy
Correlation of Risk Factors and Severity of Hypoxic-ischaemic Encephalopathy
The first aim of this study is to analyse perinatal risk factors leading to hypoxic ischaemic encephalopathy in term and near term neonates born in Switzerland who were admitted to the neonatal and intensive care units offering…
- Trial name
- NCT02800018
- Testing
- risk factors
- Where
- Switzerland
- Volunteers
- 160 people
- Sponsor
- University Children's Hospital, Zurich
Perinatal Death, Respiratory Distress Syndrome, Newborn
Maternal Hyperoxygenation for Intrapartum Fetal Heart Rate Tracing Abnormalities
Hyperoxygenation for resuscitation of abnormal fetal heart rate tracings has been routine obstetric practice. However, there have not been any studies to support this practice.
- Conditions
- Perinatal Death, Respiratory Distress Syndrome, Newborn, Hypoxic-Ischemic Encephalopathy, Neonatal Seizure
- Trial name
- NCT03996317
- Testing
- Room air
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Loma Linda University
Congenital Heart Defects, Brain Ischemia
Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit for Suspected for Brain Injury
Cardiac pathology is a major risk for brain injury and neurodevelopmental deficit. The most common cause of cardiac pathology is congenital heart defects (CHD) about 4-8/1000 live births a year.
- Conditions
- Congenital Heart Defects, Brain Ischemia, Hypoxia Brain, Child
- Trial name
- Coolheart (NCT02395276)
- Testing
- Whole body hypothermia
- Volunteers
- 75 people
- Sponsor
- Sheba Medical Center
Hypoxia-Ischemia, Brain, Signs and Symptoms
Assessing Cerebrovascular Reactivity Based on Cerebral Oximetry: a Pilot Study
The brain is such a metabolically active organ that it consumes about 20% of oxygen burned every minute by an average adult even though it only contributes about 2% of the body weight.
- Trial name
- DOSI (NCT01483495)
- Testing
- Diffuse optical spectroscopy
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- University of California, Irvine
Neonatal Hypoxic Ischemic Encephalopathy
Antenatal and Intrapartum Risk Factors Associated With Neonatal Hypoxic Ischemic Encephalopathy
Perinatal asphyxia is a major cause of hypoxic Ischemic encephalopathy (HIE), perinatal death and long term neurodisability. This can be devastating for the individual and their family; the healthcare and litigation costs…
- Trial name
- NCT04364932
- Volunteers
- 100 people
- Sponsor
- Assiut University
Hypoxic-Ischaemic Encephalopathy, Perinatal Asphyxia
Hypoxic-Ischemic Encephalopathy Therapy Optimization in Neonates for Better Neuroprotection With Inhalative CO2
This is a Phase I, open-label, single center trial to evaluate the feasibility and safety of low concentration CO2 gas mixture (5% CO2 + 95% air) inhalation in asphyxiated, cooled, mechanically ventilated newborns at risk of…
- Conditions
- Hypoxic-Ischaemic Encephalopathy, Perinatal Asphyxia, Hypocapnia
- Trial name
- HENRIC (NCT02700854)
- Testing
- 5% carbon-dioxide inhalation
- Where
- Hungary
- Volunteers
- 10 people
- Sponsor
- Semmelweis University
Hypoxic-Ischemic Encephalopathy
MRI of Neonate With HIE Before and During the Moderate Hypothermia
Moderate hypothermia has been demonstrated to be the effective treatment for neonates with hypoxic-ischemic encephalopathy (HIE). However, few studies reveal the actual alterations in physiological parameters (i.e.
- Trial name
- NCT03079492
- Testing
- Magnetic resonance imaging
- Where
- China
- Volunteers
- 30 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Cerebral Palsy, Hypoxia-Ischemia, Brain
The TOBY Children Study
The aim of this study is to determine the efficacy of therapeutic hypothermia following perinatal asphyxia on neurological and neuropsychological outcomes and also to assess academic attainment and any additional health, societal…
- Trial name
- NCT01092637
- Where
- United Kingdom
- Volunteers
- 280 people
- Sponsor
- Imperial College London
Perinatal Asphyxia
A Study of 2-Iminobiotin in Neonates With Perinatal Asphyxia
In case of insufficient oxygen supply to the brain of a newborn child (perinatal asphyxia), toxic compounds will be formed. These toxic compounds will damage the cells of the brain.
- Trial name
- NCT01626924
- Testing
- 2-Iminobiotin
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 6 people
- Sponsor
- Neurophyxia B.V.