Clinical trials: Hypoxic Ischemic Encephalopathy
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
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
Neonatal Encephalopathy
Sildenafil Administration to Treat Neonatal Encephalopathy
Despite improvements in neonatal care, birth asphyxia in term newborns remains a serious condition causing significant mortality and long-term morbidity, including cerebral palsy and mental retardation.
- Trial name
- SANE-01 (NCT02812433)
- Testing
- Sildenafil, Ora-Blend
- Where
- Canada
- Volunteers
- 28 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Hypoxic-ischemic Encephalopathy
Dexmedetomidine Pharmacokinetics in Neonates During Therapeutic Hypothermia
The goal of this proposal is to profile the pharmacokinetics of dexmedetomidine in newborns ≥36 weeks post-menstrual age during therapeutic hypothermia for hypoxic-ischemic encephalopathy.
- Trial name
- NCT02529202
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Seattle Children's Hospital
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
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)
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
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
Cardiac Arrest
Targeting the Optimal Mean Arterial Pressure in Hypoxic Ischemic Brain Injury After Cardiac Arrest
Hypoxic ischemic brain injury (HIBI) is the ensuing brain injury after cardiac arrest and is the primary cause of adverse outcome. HIBI is caused by low oxygen delivery to the brain.
- Trial name
- CAMPING (NCT04081506)
- Testing
- Individualized perfusion targets
- Sponsor
- University of British Columbia
Disorder of Consciousness, Traumatic Brain Injury
Sub-study of the NEURODOC Project : Neurophysiological Evaluation of a Routine Care Open Label tDCS Session
Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of…
- Conditions
- Disorder of Consciousness, Traumatic Brain Injury, Anoxic Brain Injury, Stroke
- Trial name
- Neurodoc (NCT04035655)
- Testing
- Coma Recovery Scale - revised, Electrophysiological recordings
- Where
- France
- Volunteers
- 66 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
Birth Asphyxia
Asphyxia Associated Metabolite Biomarker Investigation 2
Follow-up of participants of AAMBI1 study at age of at least 2 years. AAMBI1(ClinicalTrials.gov ID: NCT03354208): Verification of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia.
- Trial name
- AAMBI2 (NCT04714502)
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 144 people
- Sponsor
- InfanDx AG
Hypoxic Ischemic Encephalopathy (HIE)
Neonates With Hypoxic Ischemic Encephalopathy (HIE)
Assessment of the potential neuroprotective effect of magnesium sulphate and caffeine in treating asphyxiated newborns and improvement of the neurological outcome of Hypoxic Ischemic Encephalopathy in Assiut university hospital…
- Trial name
- NCT06694545
- Volunteers
- 72 people
- Sponsor
- Assiut University
Hypoxic-Ischemic Encephalopathy
Florida Neonatal Neurologic Network
Create a database with selected medical information on infants born with hypoxic-ischemic encephalopathy (HIE). In addition, the following samples will be collected in a bio-repository for future studies: blood, urine, and buccal…
- Trial name
- FN3 (NCT02260271)
- Testing
- Database Entry/Biospecimen Collection
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- University of Florida
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
Brain Injury Traumatic Severe (Diagnosis), Coma
Stimulant Therapy Targeted to Individualized Connectivity Maps to Promote ReACTivation of Consciousness
Phase 1 of the STIMPACT trial is an open label,dose-escalation,safety study of intravenous (IV) methylphenidate (MPH) therapy in patients with disorders of consciousness (DoC) caused by severe brain injuries.
- Conditions
- Brain Injury Traumatic Severe (Diagnosis), Coma, Consciousness, Level Altered, Anoxic Brain Injury
- Trial name
- STIMPACT (NCT03814356)
- Testing
- Methylphenidate
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Massachusetts General Hospital
EEG, Neonatology
An Observational Study of the NeuroBell EEG Monitor
An observational clinical investigation of the NeuroBell EEG Monitor (a portable and wireless EEG monitor).
- Conditions
- EEG, Neonatology, Seizure, Neurology
- Trial name
- NCT07508670
- Testing
- NeuroBell EEG Monitor
- Where
- Ireland
- Volunteers
- 17 people
- Sponsor
- University College Cork