Clinical trials: HIE - Hypoxic - Ischemic Encephalopathy
Hypoxic-ischemic Encephalopathy
Neonatal Erythropoietin in Asphyxiated Term Newborns
The purpose of this study is to determine the safety and pharmacokinetics of moderate to high doses of erythropoietin in newborn infants with birth asphyxia.
- Trial name
- NEAT (NCT00719407)
- Testing
- erythropoietin
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of California, San Francisco
Neonatal Seizures
Levetiracetam Treatment of Neonatal Seizures: Safety and Efficacy Phase II Study
LEVNEONAT is a multicentre French clinical trials with the aim to develop new treatment strategies for the treatment of neonatal seizures using Levetiracetam.
- Trial name
- LEVNEONAT-1 (NCT02229123)
- Testing
- Intravenous Levetiracetam
- Where
- 8 sites in France
- Volunteers
- 18 people
- Sponsor
- University Hospital, Tours
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
Motor Disorders, Neurodevelopmental Disorders
Neuromotor Development and Motor Related Health Care in Children with a High Risk Neonatal Period
The overall aim of the study is to evaluate the prevalence of motor- and neurological disorders (cerebral pares and other less severe motor disorders) in Swedish infants with a high-risk neonatal period and to elucidate whether…
- Conditions
- Motor Disorders, Neurodevelopmental Disorders, Premature Birth, Hypoxic-Ischemic Encephalopathy
- Trial name
- NCT06645717
- Volunteers
- 2,900 people
- Sponsor
- Karolinska Institutet
Hypoxic-ischemic Encephalopathy (HIE)
Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy in Vietnam
This study aims to evaluate the effectiveness of therapeutic hypothermia in neonates diagnosed with hypoxic-ischemic encephalopathy (HIE).
- Trial name
- HIE-TH Vietnam (NCT07555652)
- Testing
- Therapeutic Hypothermia
- Where
- Vietnam
- Volunteers
- 120 people
- Sponsor
- National Children's Hospital, Vietnam
Encephalopathy, Hypoxic-Ischemic
PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment.
This study is a prospective, observational, single-center study to assess the correlation between rs-fMRI measures and clinical measures of standard MRI, NIRS, EEG and clinical scores.
- Trial name
- PEDI-REAVASC (NCT06370624)
- Testing
- MRI-scan
- Where
- Belgium
- Volunteers
- 30 people
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Hypoxic Ischaemic Encephalopathy (HIE)
Effect of Citicoline on Neurological Severity Score and Cerebral Doppler Resistive Index in Neonatal Hypoxic Ischemic Encephalopathy
To determine the efficacy of citicoline in improving cerebral blood flow parameters and neurological status among neonates with hypoxic-ischemic encephalopathy using Doppler resistive index and Sarnat-Sarnat score after 72 hours…
- Trial name
- NCT07763145
- Testing
- Citicoline, Standard medical treatment
- Where
- Pakistan
- Volunteers
- 86 people
- Sponsor
- Khyber Girls Medical College
Hypoxic-Ischemic Encephalopathy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant…
- Trial name
- STAR (NCT05778188)
- Testing
- RLS-0071
- Where
- 22 sites in United States
- Volunteers
- 173 people
- Sponsor
- ReAlta Life Sciences, Inc.
Neonatal Hypoxic-Ischemic Encephalopathy (HIE)
CoolCap Trial, Treatment of Perinatal Hypoxic-Ischemic Encephalopathy
This is a research study of head cooling. Its goal is to determine whether cooling babies' heads can reduce or prevent brain damage that may have resulted from temporarily reduced oxygen supply to the brain.
- Trial name
- NCT00383305
- Testing
- Cool-Cap
- Where
- 27 sites in United States, Canada and 2 more
- Volunteers
- 235 people
- Sponsor
- Olympic Medical
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
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
Hypoxic-Ischemic Encephalopathy, Hepatitis B Vaccination
Hypothermia's Effect on Hepatitis B Vaccination
The purpose of the research is to determine if the Hepatitis B vaccine after birth provides enough protection after cooling for Hypoxic Ischemic Encephalopathy (HIE).
- Conditions
- Hypoxic-Ischemic Encephalopathy, Hepatitis B Vaccination, Hypothermia, Newborn
- Trial name
- NCT05787899
- Testing
- Hypothermia Protocol
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Medical University of South Carolina
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, 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, 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
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
Effect of Reflexology, Hypoxic-Ischemic Encephalopathy, Neonatal
Foot Reflexology in Neonates With Hypoxic-Ischemic Encephalopathy
This randomized controlled trial aims to evaluate the effect of foot reflexology on comfort levels and physiological parameters in neonates with hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia.
- Conditions
- Effect of Reflexology, Hypoxic-Ischemic Encephalopathy, Neonatal, Foot Reflexology, Therapeutic Hypothermia
- Trial name
- NCT07549789
- Testing
- Foot reflexology, Standard care
- Where
- Turkey (Türkiye)
- Volunteers
- 84 people
- Sponsor
- Istanbul Nisantasi University
Swallowing Disorder, Perinatal Asphyxia
Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia
The transition period to full oral feeding in infants with perinatal asphyxia is important in predicting long-term outcomes. The transition to independent oral feeding is accepted as a discharge criterion by the American Academy…
- Conditions
- Swallowing Disorder, Perinatal Asphyxia, Feeding; Difficult, Newborn, Feeding Disorder of Infancy or Early Childhood
- Trial name
- NCT05687708
- Testing
- Non-Nutritive Sucking
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Medipol University
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