Clinical trials: Hypoxic-Ischemic Brain Injury
Hypoxic Ischemic Encephalopathy
Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy
The purpose of this study is to determine the efficacy of high dose Erythropoietin to improve survival and neurologic outcome in asphyxiated term newborn undergoing cooling.
- Trial name
- Neurepo (NCT01732146)
- Testing
- erythropoietin Beta
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Music Therapy, Pain
Music Therapy During Hypothermia in the NICU
Background: Hypoxic-ischemic encephalopathy (HIE) is a neurological condition caused by poor oxygenation during the peripartum period.
- Conditions
- Music Therapy, Pain, Allodynia, Neonates
- Trial name
- NCT06951269
- Testing
- Live entrained music therapy
- Where
- Colombia
- Volunteers
- 22 people
- Sponsor
- Fundación Santa Fe de Bogota
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
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-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
Hypoxia, Brain, Hypoxia-Ischemia, Brain
Home Stimulation for Brain-Asphyxiated Infants
This study examines the potential benefits of a home stimulation program to treat infants who have suffered from brain asphyxiation (lack of oxygen). The program involves one year of stimulatory activities.
- Trial name
- NCT00006516
- Testing
- Infant stimulation
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Cerebral Palsy, Hydrocephalus
Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries
This protocol is designed to enable access to intravenous infusions of banked umbilical cord blood (CB), that is thawed and not more than minimally manipulated, for children with various brain disorders.
- Conditions
- Cerebral Palsy, Hydrocephalus, Apraxia of Speech, Hypoxia Ischemia, Cerebral
- Trial name
- NCT03327467
- Testing
- Cord Blood Infusion
- Where
- United States
- Sponsor
- Joanne Kurtzberg, MD
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
Cardiac Arrest
Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial
Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in which the body's temperature is lowered and maintained several degrees below normal for a period of time, has been used to successfully…
- Trial name
- THAPCA-IH (NCT00880087)
- Testing
- Therapeutic Hypothermia, Therapeutic Normothermia
- Where
- 33 sites in United States, Canada and 1 more
- Volunteers
- 329 people
- Sponsor
- University of Michigan
Newborn Asphyxia
Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy
Therapeutic hypothermia (TH) is the standard of care for newborns with moderate to severe hypoxic-ischaemic encephalopathy (HIE) born at 35 weeks or more of gestation.
- Trial name
- NCT06394453
- Testing
- enteral feeding with mother milk or human donor breast milk
- Where
- Poland
- Volunteers
- 104 people
- Sponsor
- Nutricia Foundation
HIE, TBI (Traumatic Brain Injury)
Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)
This is an observational study in patients who require clinical anesthesia. The main purpose of this study is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by different…
- Conditions
- HIE, TBI (Traumatic Brain Injury), TBI, Hemodynamic Instability
- Trial name
- ICHOR 1 (NCT06195345)
- Testing
- MR Imaging
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Los Angeles
Hypoxic-Ischemic Encephalopathy
PAEAN - Erythropoietin for Hypoxic Ischaemic Encephalopathy in Newborns
Double-blind, placebo controlled Phase III trial of erythropoietin for hypoxic ischaemic encephalopathy in infants receiving hypothermia.
- Trial name
- PAEAN (NCT03079167)
- Testing
- Epoetin Alfa, Normal saline
- Where
- 24 sites in Australia, New Zealand and 1 more
- Volunteers
- 313 people
- Sponsor
- University of Sydney
Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia
Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Treadmill
There have been many studies on the use of running training in older children to improve gait development in children with cerebral palsy.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia, Intraventricular Hemorrhage Neonatal, Bilirubin Encephalopathy
- Trial name
- NCT03534466
- Testing
- Baby treadmill, Conventional physical rehabilitation training
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Children's Hospital of Fudan University
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
Perinatal Stroke
Baby Brain Recovery Study
This study will be a longitudinal multiple-visit observational study, done to identify possible bioindicators of recovery and repair of motor corticospinal pathways which may be targeted by future interventions in infants with…
- Trial name
- NCT05013736
- Testing
- Magnetic Resonance Imaging, Behavioral Assessments, Non invasive Transcranial Magnetic Stimulation
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- University of Wisconsin, Madison
Brain Injuries, Congenital Heart Disease
Protecting Brains and Saving Futures - the PBSF Protocol
Background: Multiple neonatal disorders are associated with risks of neurological injury. Thus, management of these infants should involve a coordinated approach to permit early diagnosis with improved clinical care.
- Conditions
- Brain Injuries, Congenital Heart Disease, Newborn Morbidity, Intraventricular Hemorrhage
- Trial name
- PBSF (NCT03786497)
- Where
- 2 sites in Brazil
- Volunteers
- 2,268 people
- Sponsor
- Protecting Brains Saving Futures
Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy
Investigating Cerebral Oxygenation in the Newborn
The goal of this single centre observational study is to use near-infrared spectroscopy (NIRS) monitoring to investigate cerebral oxygenation in two groups of newborn infants who are at high risk of brain injury.
- Conditions
- Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy, Premature Infant Disease
- Trial name
- ICON (NCT05588960)
- Testing
- Near-infrared spectroscopy monitoring (Masimo O3 Regional Oximeter with Neonatal Sensor)
- Where
- United Kingdom
- Volunteers
- 99 people
- Sponsor
- University of Edinburgh
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
Hypoxic Ischemic Encephalopathy
Erythropoietin in Infants With Hypoxic Ischemic Encephalopathy (HIE)
In this prospective trial the investigators plan to study the efficacy of erythropoietin as a therapeutic agent in neonates who suffer from brain injury following perinatal asphyxia.
- Trial name
- NCT00945789
- Testing
- Human recombinant erythropoietin, EEG and Brain MRI, Nitric oxide measurement in the blood
- Where
- Egypt
- Volunteers
- 45 people
- Sponsor
- Tanta University
Hypoxic-Ischemic Encephalopathy, Cardiac Arrest
Propofol-induced EEG Changes in Hypoxic Brain Injury
PROPEA3 is a prospective observational study investigating the recovery of propofol-induced EEG slow-wave activity and its association with neurological outcome after cardiac arrest.
- Trial name
- PROPEA3 (NCT03485781)
- Where
- 2 sites in Finland
- Volunteers
- 102 people
- Sponsor
- University of Oulu