Clinical trials: Hypoxic Ischemic Brain Injury
Hypoxic Ischemic Encephalopathy
MRI Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy(HIE)
Hundreds of babies in the world are being treated with brain cooling to prevent brain injury after they lose oxygen at birth. This study will use the newly developed information from the magnet resonance image to determine the…
- Trial name
- NCT01128673
- Testing
- mRI
- Where
- United States
- Sponsor
- Vanderbilt University
Hypoxic Ischemic Encephalopathy of Newborn, Hypoxic Ischemic Encephalopathy
The HIEnome Study: Genome Sequencing for Perinatal HIE
Perinatal hypoxic-ischemic encephalopathy is a rare severe condition in which neonates present with encephalopathy and a clinical history suggestive of prenatal or perinatal hypoxic-ischemic injury.
- Conditions
- Hypoxic Ischemic Encephalopathy of Newborn, Hypoxic Ischemic Encephalopathy, Hypoxic Ischemic Encephalopathy (HIE)
- Trial name
- NCT06762795
- Testing
- Genome sequencing
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Baylor College of Medicine
Small for Gestational Age at Delivery, Hypoxic-Ischemic Encephalopathy
Umbilical Cord Abnormalities in the Prediction of Adverse Pregnancy Outcomes
The objective of our study is to investigate the association of umbilical cord abnormalities with adverse pregnancy outcomes. The umbilical cord parameters that will be investigated as part of this study include the umbilical…
- Conditions
- Small for Gestational Age at Delivery, Hypoxic-Ischemic Encephalopathy, Stillbirth, Admission to Neonatal Unit
- Trial name
- ULOOP (NCT05901688)
- Testing
- Umbilical cord measurements & observations
- Where
- United Kingdom
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Medway NHS Foundation Trust
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
Hypoxic Ischemic Encephalopathy (HIE)
Caffeine for Hypoxic Ischemic Encephalopathy
CHIME is a randomized, parallel-arm, double-blind, placebo-controlled trial focused on infants with hypoxic ischemic encephalopathy (HIE).
- Trial name
- CHIME (NCT06855108)
- Testing
- Caffeine citrate oral solution
- Where
- 7 sites in Bangladesh, Democratic Republic of the Congo and 4 more
- Volunteers
- 830 people
- Sponsor
- NICHD Global Network for Women's and Children's Health
Hypoxic-Ischemic Encephalopathy
Neural Progenitor Cell and Paracrine Factors to Treat Hypoxic Ischemic Encephalopathy
The purpose of this study is to investigate the efficacy and safety of allogenic neural progenitor cell and paracrine factors of human mesenchymal stem cells for patients with moderate/severe Hypoxic-Ischemic Encephalopathy
- Trial name
- NCT02854579
- Testing
- neural progenitor cell, Paracrine factors, progenitor cell and paracrine factors
- Where
- 2 sites in China
- Volunteers
- 120 people
- Sponsor
- Navy General Hospital, Beijing
Hypoxic-Ischaemic Encephalopathy, Neonatal Encephalopathy
Intranasal Breast Milk Therapy in HIE
This is an open-label prospective single-center randomized controlled trial to evaluate the effect of intranasal breast milk in hypoxic-ischemic encephalopathic neonates receiving therapeutic hypothermia on long term…
- Conditions
- Hypoxic-Ischaemic Encephalopathy, Neonatal Encephalopathy, Perinatal Asphyxia, Neonatal Hypoxic Ischemic Encephalopathy
- Trial name
- NEO-BRIGHT (NCT06746532)
- Testing
- Intranasal breast milk
- Where
- Hungary
- Volunteers
- 80 people
- Sponsor
- Semmelweis University
Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD)
Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders
This observational study evaluates functional and developmental outcomes in pediatric participants undergoing a two week intensive multimodal neurorehabilitation program.
- Conditions
- Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD), Neurodevelopmental Disorders and Developmental Abnormalities, Developmental Delay (Disorder)
- Trial name
- GEN-HOPE (NCT07493096)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Healing Hope International
Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia
Intranasal Stem Cells to Treat Perinatal Brain Injury to Combat Cerebral Palsy
Hypoxic-ischemic brain injury (HIBI) is a leading cause of death and lifelong disability in near-term and term infants, most often caused by perinatal arterial ischemic stroke (PAIS, incidence approximately 1:5000 live births) or…
- Conditions
- Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia, Hypoxic-Ischemic Brain Injury, PAIS
- Trial name
- iSTOP-CP (NCT07831746)
- Testing
- MSC, marrow
- Volunteers
- 162 people
- Sponsor
- UMC Utrecht
Encephalopathy, Hypoxic-Ischemic
Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia
This research is being done to find out the safety of the investigational study drug, Clonidine Hydrochloride ( CLON). , in infants who are undergoing whole body cooling for the treatment of hypoxic ischemic encephalopathy (HIE).
- Trial name
- HIE (NCT01862250)
- Testing
- Clonidine (Duraclon®)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Johns Hopkins University
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
Hypoxic-Ischemic Encephalopathy, HIE
A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury
Infants with hypoxic-ischemic encephalopathy (HIE) are at high risk for neurodevelopmental impairment, despite current standards of care. Adjunctive treatments to promote brain repair are needed.
- Conditions
- Hypoxic-Ischemic Encephalopathy, HIE, Neurodevelopment, Infant Development
- Trial name
- NCT06429007
- Testing
- Metformin
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Boston Children's Hospital
Hypoxic-Ischemic Encephalopathy, Asphyxia
Hydrocortisone Treatment In Systemic Low Blood Pressure During Hypothermia in Asphyxiated Newborns
This is a prospective, randomized, double-blind, placebo controlled, single center study to compare low dose hydrocortisone vs placebo in systemic low blood pressure during hypothermia treatment in asphyxiated newborns.
- Trial name
- CORTISoL (NCT02700828)
- Testing
- Hydrocortisone
- Where
- Hungary
- Volunteers
- 32 people
- Sponsor
- Semmelweis University
Cerebral Palsy, Cerebral Palsy (CP)
Assessing Intellectual and Motor Outcomes in High-risk Infants
Cerebral palsy (CP) is a condition when a baby has a brain injury that affects their movement and muscle tone. Some people with CP can have other developmental issues, like learning impairments, but many do not and have isolated…
- Conditions
- Cerebral Palsy, Cerebral Palsy (CP), Cerebral Palsy Children, High-risk Infants
- Trial name
- AIM-High (NCT06857539)
- Where
- 4 sites in Ireland
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- University College Cork
Hypoxic-Ischemic Encephalopathy, Pain
The Effect of Maternal Scent and Knitted Octopus Application on Pain in Infants Diagnosed With Neonatal Asphyxia and Receiving Therapeutic Hypothermia Treatment
This study was designed to determine the effects of maternal scent and knitted octopus application on pain in infants born with asphyxia beyond 36 weeks' gestation and receiving Therapeutic Hypothermia (TH) treatment in the…
- Trial name
- Pain in HIE (NCT07526233)
- Testing
- scent
- Where
- Turkey (Türkiye)
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Alev Sivasli
Hypoxic Ischemic Encephalopathy
Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Hypoxic Ischemic Encephalopathy
This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in hypoxic ischemic encephalopathy.
- Trial name
- NCT01962233
- Testing
- mesenchymal stem cells
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Hebei Medical University
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
Neonatal Hypoxic-ischaemic Encephalopathy
Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells
Neonatal hypoxic-ischaemic encephalopathy is a dramatic perinatal complication due to brain asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal damage and loss.
- Trial name
- NEOSTEM (NCT02881970)
- Testing
- autologous cord blood stem cell
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
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
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary 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
- 15 sites in United States
- Volunteers
- 70 people
- Sponsor
- ReAlta Life Sciences, Inc.