Clinical trials: Hypoxic Ischemic Brain Injury
Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns
A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy
This study will test the safety and efficacy of an infusion of a baby's own (autologous) umbilical cord blood as compared with placebo in babies born with history and signs of hypoxic-ischemic brain injury.
- Trial name
- (HIE) (NCT02612155)
- Testing
- Infusion of autologous cord blood
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Michael Cotten
Hypoxic-Ischemic Encephalopathy, Acute Kidney Injury
Renal and Cerebral NIRS and Early Acute Kidney Injury in Cooled Neonates With Birth Asphyxia
This prospective, single-center observational cohort study evaluated whether continuous cerebral and bilateral renal near-infrared spectroscopy (NIRS) monitoring during therapeutic hypothermia distinguishes term neonates with…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Neonatal, Asphyxia Neonatorum
- Trial name
- NCT07743099
- Testing
- 1- Continuous Cerebral Near-Infrared Spectroscopy, 2- Continuous Bilateral Renal Near-Infrared Spectroscopy
- Where
- Turkey (Türkiye)
- Volunteers
- 46 people
- Sponsor
- Agah Bahadır Öztürk,MD
Cerebral Palsy, Hypoxic-Ischemic Encephalopathy
Therapeutic Intervention Supporting Development From NICU to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy
The purpose of this study is to evaluate the feasibility and begin to evaluate the effect of a sensorimotor intervention (SMI) provided in the first 6 months of life for infants with hypoxic-ischemic encephalopathy.
- Trial name
- NCT05130528
- Testing
- Sensorimotor Intervention
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- University of Southern California
Cardiac Arrest (CA), Cerebrospinal Fluid
Molecular Insights Into Post-Cardiac Arrest Brain Injury Via CSF Multi-Omics
The goal of this study is to uncover the molecular mechanisms responsible for secondary brain injury in patients with post-cardiac arrest syndrome by analyzing cerebrospinal fluid (CSF) using multi-omics techniques.
- Conditions
- Cardiac Arrest (CA), Cerebrospinal Fluid, Multiomics, Hypoxic-Ischemic Brain Injury
- Trial name
- PCABI-OMICS (NCT07481396)
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Chungnam National University Hospital
Birth Asphyxia
First-day High Dose Vitamin C, E in Severe Birth Asphyxia
To study the role of first-day high dose oral vitamin C and first-day single high dose oral vitamin E in hypoxic-ischemic encephalopathy in newborns, in the reduction of morbidity and adverse neurodevelopmental sequelae.
- Trial name
- CEBA (NCT01743742)
- Testing
- Vitamin E, Vitamin C
- Where
- India
- Volunteers
- 95 people
- Sponsor
- Sir Takhtasinhji General Hospital
Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy
Healthy Little Eyes
The purpose of this research study is to gather more information on how eye injury is related to a baby's future development and see if eye function and brain test results can be used, along with current measures, to better…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy, Encephalopathy
- Trial name
- NCT05971446
- Testing
- Visual Evoked Potential (VEP), Electroretinogram (ERG)
- Where
- United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
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
Hypoxic-Ischemic Encephalopathy
Erythropoietin in Management of Neonatal Hypoxic Ischemic Encephalopathy
Perinatal hypoxic-ischaemic encephalopathy occurs in one to three infants per 1000 term births, and up to 12 000 infants are affected each year in the united state of America.
- Trial name
- NCT03163589
- Testing
- Erythropoietin, normal saline
- Volunteers
- 40 people
- Sponsor
- Assiut University
Asphyxia Neonatorum
Biomarkers And Neurological Outcome in Neonates 2
Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data in a human population for their…
- Trial name
- BANON2 (NCT04714775)
- Where
- 13 sites in Germany, Turkey (Türkiye)
- Volunteers
- 500 people
- Sponsor
- InfanDx AG
Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)
Cytokines Associated With Cord Blood Cell Therapy for Neonatal Encephalopathy
This is a observational study to assess the effects of and to explore the mechanisms of autologous umbilical cord blood cell therapy for neonatal encephalopathy by way of measuring serum cytokines.
- Trial name
- NCT02455830
- Testing
- Autologous cord blood cell therapy
- Where
- 6 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Neonatal Encephalopathy Consortium, Japan
Moderate to Severe Hypoxic-ischemic Encephalopathy
Study of hCT-MSC in Newborn Infants With Moderate or Severe HIE
To determine the safety of single and repeated intravenous doses of hCT-MSC in newborn infants with HIE.
- Trial name
- NCT03635450
- Testing
- Infusion of hCT-MSC
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Joanne Kurtzberg, MD
Hypoxic Ischemic Encephalopathy
Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
The goal is to see whether topiramate (an anti-epileptic agent) improves the outcome of babies with neonatal hypoxic encephalopathy who are receiving whole body cooling.
- Trial name
- NCT01765218
- Testing
- Topiramate
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Kristin R Hoffman
Neonatal Seizure, Neonatal Encephalopathy
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
The main purpose of this study is to determine the maximum safe tolerated dose of LEV in the treatment of neonatal seizures. Our hypothesis is that optimal dosing of Levetiracetam (LEV) to treat neonatal seizures is significantly…
- Conditions
- Neonatal Seizure, Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Seizure Newborn
- Trial name
- NEOLEV3 (NCT05610085)
- Testing
- Levetiracetam Injection, Phenobarbital Sodium Injection
- Where
- 6 sites in United States, New Zealand
- Volunteers
- 133 people
- Sponsor
- University of California, San Diego
Disorder of Consciousness, Stroke
tDCS and rTMS in Patients With Early Disorders of Consciousness
A randomized controlled study was conducted to explore the efficacy of early transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) to promote wakefulness in patients with disorder…
- Conditions
- Disorder of Consciousness, Stroke, Ischemic-hypoxic Encephalopathy
- Trial name
- NCT05820178
- Testing
- tDCS, rTMS
- Volunteers
- 120 people
- Sponsor
- Xuanwu Hospital, Beijing
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, Sepsis
Continous Renal Replacement Therapy With the CARPEDIEM® in a French National Cohort of 25 Neonates and Small Infants
Historically, CKRT and hemodialysis were performed in small infants and newborns with devices developed for adults with high rates of complications and mortality.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Sepsis, Kidney Diseases, Metabolic Disease
- Trial name
- NCT05495607
- Testing
- CARPEDIEN
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
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
Whole Body Cooling Using Phase Changing Material
A prospective randomized control trial to examine safety and effectiveness of whole body cooling to a rectal temperature of 33.5 C using phase changing material in neonatal encephalopathy.
- Trial name
- NCT01138176
- Testing
- Cooling
- Where
- India
- Volunteers
- 35 people
- Sponsor
- Robertson, Nicola, M.D.
Infant, Newborn, Hypoxia, Brain
Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)
The Optimizing Cooling trial will compare four whole-body cooling treatments for infants born at 36 weeks gestational age or later with hypoxic-ischemic encephalopathy: (1) cooling for 72 hours to 33.5°C; (2) cooling for 120…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT01192776
- Testing
- Whole-body Cooling
- Where
- 19 sites in United States
- Volunteers
- 364 people
- Sponsor
- NICHD Neonatal Research Network
Newborn Hypoxic-Ischemic Encephalopathy
Evaluation of a PCM Mattress to Treat HIE Infants During Transport
Background the research proposed herein is in line with the Swedish Research Council's current focus on International collaborations and postdoctoral work abroad.
- Trial name
- PCMhypo (NCT05361473)
- Testing
- The NeoHilda Point of care method, Traditional evaluation
- Where
- Vietnam
- Volunteers
- 140 people
- Sponsor
- Karolinska Institutet