Clinical trials: Encephalopathy, Hypoxic-Ischemic
Neonatal Hypoxic Ischemic Encephalopathy, Neonatal Stroke
Neonatal Brain Ultrasound With CEUS and Elastography
The aim of our study is to investigate changes of brain perfusion and elasticity in neonates during the time that a neonate is adapting to live outside the womb and during diseases that are suspected to affect neonatal brain…
- Conditions
- Neonatal Hypoxic Ischemic Encephalopathy, Neonatal Stroke, Neonatal Encephalopathy, Unspecified
- Trial name
- NCT05648812
- Testing
- Brain contrast enhanced ultrasound, brain ultrasound elastography, Sulfur Hexafluoride
- Where
- Finland
- Volunteers
- 100 people
- Sponsor
- Turku University Hospital
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
Hypoxic-Ischemic Encephalopathy, Brain Injury
Prospective Research in Infants With Mild Encephalopathy
A multicenter observational pilot study will be conducted to determine the natural history of infants with early diagnosis (≤ 6 hrs of age) of mild neonatal encephalopathy (NE) who are not qualified for therapeutic hypothermia.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Brain Injury, Neonatal Seizure
- Trial name
- PRIME (NCT01747863)
- Testing
- Neurologic examination
- Where
- 7 sites in United States, Canada and 2 more
- Volunteers
- 63 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
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
Traumatic Brain Injury, Ischemic Stroke
Detection of Cerebral Ischemia With a Noninvasive Neurometabolic Optical Monitor
The goals of the project are to evaluate a noninvasive monitor of brain metabolism and blood flow in critically ill humans. If validated, such a reliable noninvasive brain blood flow and metabolism monitor, by allowing…
- Conditions
- Traumatic Brain Injury, Ischemic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage
- Trial name
- NNOM (NCT02983786)
- Testing
- Indocyanine Green
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- University of Pennsylvania
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, Neonatal Convulsions
Intra-operative Feed Back on Traction Force During Vacuum Extraction: Safe Vacuum Extraction Alliance
The objective of the clinical investigation is to test whether intra-operative traction force feed back during vacuum extraction leads to a significant decrease in incidence of brain damage in neonates.
- Conditions
- Hypoxic Ischemic Encephalopathy, Neonatal Convulsions, Subgaleal Hematoma
- Trial name
- SVEA (NCT03071783)
- Testing
- Vacuum extraction intelligent system
- Where
- Sweden
- Volunteers
- 800 people
- Sponsor
- Karolinska Institutet
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
Hypoxic Ischemic Encephalopathy
Autologous Cord Blood Cells for Brain Injury in Term Newborns
This is a pilot study to test feasibility and safety of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood during the first 3 days of age if the baby is born with signs of brain injury.
- Trial name
- NCT01649648
- Testing
- Autologous cord blood
- Where
- 3 sites in Singapore
- Volunteers
- 2 people
- Sponsor
- National University Hospital, Singapore
Neonates With HIE
Magnesium Sulfate in Neonatal HIE"
The study will investigates the neuroprotective effects of intravenous magnesium sulfate in neonates with hypoxic-ischemic encephalopathy (HIE) at a Karachi tertiary care hospital.
- Trial name
- NCT06342362
- Testing
- Magnesium sulfate
- Where
- Pakistan
- Volunteers
- 102 people
- Sponsor
- Sindh Institute of Child Health and Neonatology
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
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
Cerebral Palsy Hypoxic-Ischemic Encephalopathy Intracranial Hemorrhage
Autologous Bone Marrow Mononuclear Cell Transplantation Combined With Rehabilitation in Children With Sequelae of Hypoxic-Ischemic Encephalopathy or Intracranial Hemorrhage
This study evaluates the safety and preliminary efficacy of autologous bone marrow mononuclear cell transplantation combined with rehabilitation in children with neurological sequelae caused by hypoxic-ischemic brain injury or…
- Trial name
- BMMCT-CP (NCT07527104)
- Testing
- Autologous Bone Marrow Mononuclear Cell Transplantation
- Where
- Vietnam
- Volunteers
- 60 people
- Sponsor
- National Children's Hospital, Vietnam
Hypoxic-Ischemic Encephalopathy, Cell Damage
Use of Melatonin for Neuroprotection in Asphyxiated Newborns
Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Hypoxic-Ischemic Encephalopathy (HIE) occurs in 3-5 per 1000 births. Only 47% of neonates have normal outcomes.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Cell Damage, Asphyxia Perinatal
- Trial name
- MELPRO (NCT03806816)
- Testing
- Melatonin
- Where
- 6 sites in Holy See, Italy
- Volunteers
- 100 people
- Sponsor
- University Hospital of Ferrara
Hypoxic Ischaemic Encephalopathy (HIE), Premature Birth
Healing Tiny Minds: Rural Recovery Through Virtual and Lived Experience Care
The goal of this behavioral-interventional study is to learn if the Abecedarian Approach implemented virtually for children ages 0-5 with a history of Hypoxic Ischaemic Encephalopathy (HIE) and/or premature birth produces the…
- Conditions
- Hypoxic Ischaemic Encephalopathy (HIE), Premature Birth, Cerebral Palsy, Neurological Disorder
- Trial name
- NCT06643598
- Testing
- Abecedarian Approach
- Where
- United States
- Volunteers
- 225 people
- Sponsor
- University of Wisconsin, Madison
Acute Brain Injury, Hypoxia, Brain
Portable MRI for Pediatric Hypoxic Ischemic Brain Injury
This study will evaluate the sensitivity and specificity of low field portable MRI (pMRI) for detection of hypoxic ischemic brain injuries in pediatric patients compared to clinically obtained neuroimaging to define pediatric…
- Conditions
- Acute Brain Injury, Hypoxia, Brain, Ischemia, Brain, Brain Injuries
- Trial name
- pMRI for HIBI (NCT07577336)
- Testing
- Portable MRI, Scavenged Sample Collection
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Children's Mercy Hospital Kansas City
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Clinical evaluation of the possible neuroprotective effect of early prophylactic high dose of Levetiracetam as adjunctive therapy to WBC in neonates with HIE.
- Trial name
- NCT07897032
- Testing
- Levetiracetam, Therapeutic hypothermia (whole body cooling)
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Alexandria University
Neonatal Asphyxial Encephalopathy, Hypoxic Ischemic Encephalopathy
Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy
This study was a multicenter, randomized, controlled pilot trial of moderate systemic hypothermia (33°C) vs normothermia (37°C) for 48 hours in infants with neonatal encephalopathy instituted within 6 hours of birth or…
- Trial name
- NCT02826941
- Testing
- hypothermia, normothermia
- Volunteers
- 65 people
- Sponsor
- Medical University of South Carolina
Hypoxic-ischemic Encephalopathy (HIE)
The PROTECT-HIE Pilot Trial
Some babies experience a lack of oxygen and blood flow around the time of birth. This can lead to a serious condition called hypoxic-ischemic encephalopathy (HIE), which can injure the brain and other organs, including the heart.
- Trial name
- PROTECT-HIE (NCT07406477)
- Testing
- Dobutamine, TnECHO
- Where
- 2 sites in Canada
- Volunteers
- 40 people
- Sponsor
- University of Alberta
Seizures
Pilot Study of Bumetanide for Newborn Seizures
The main goal of the study is to obtain pharmacokinetic and safety data of bumetanide in newborns with refractory seizures. The overall hypothesis is that bumetanide, added to conventional antiepileptic (antiseizure) medications…
- Trial name
- NCT00830531
- Testing
- Bumetanide
- Where
- 4 sites in United States
- Volunteers
- 43 people
- Sponsor
- Soul, Janet , M.D.