Clinical trials: Encephalopathy, Hypoxic-Ischemic
Hypoxic-Ischemic Encephalopathy
Holding, Stress, and Bonding During Therapeutic Hypothermia
Ten infants undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy will be enrolled in a new protocol that will allow mothers to hold their infants during the hypothermia treatment period.
- Trial name
- NCT03079284
- Testing
- Holding during cooling
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Alexa Craig
Hypoxic-Ischemic Encephalopathy
Systemic Hypothermia Improves Outcome of Hypoxic-Ischemic Encephalopathy
Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and mortality in term and preterm neonates.
- Trial name
- NCT00817401
- Testing
- hypothermia
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Zhengzhou University
Urea Cycle Disorder, Organic Acidemia
Systemic Biomarkers of Brain Injury From Hyperammonemia
Ammonia is a waste product of protein and amino acid catabolism and is also a potent neurotoxin. High blood ammonia levels on the brain can manifest as cytotoxic brain edema and vascular compromise leading to intellectual and…
- Conditions
- Urea Cycle Disorder, Organic Acidemia, Maple Syrup Urine Disease, Glutaric Acidemia I
- Trial name
- NCT04602325
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Children's National Research Institute
Traumatic Brain Injury
A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy for the Treatment of Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy
This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on brain structure, neurocognitive/functional outcomes, and neuroinflammation after subacute and chronic neurological injury…
- Trial name
- NCT04063215
- Testing
- HB-adMSCs
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Hope Biosciences LLC
Hypoxic-Ischemic Encephalopathy
Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy
Citicoline, is a naturally occurring compound and an intermediate in the metabolism of phosphatidylcholine. Phosphatidylcholine is an important component of the phospholipids of the cell membranes.
- Trial name
- citicoline (NCT03181646)
- Testing
- citicoline
- Where
- Pakistan
- Volunteers
- 50 people
- Sponsor
- Armed Forces Hospital, Pakistan
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
Encephalopathy, Hypoxic Ischemic
Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia
The goal of this observational study is to identify early signs of poor neurodevelopmental outcome by performing specific neurological, neurophysiological and neuroimaging assessments in newborns with hypoxic-ischemic…
- Trial name
- NCT05767476
- Testing
- Clinical and instrumental neurological assessment
- Where
- 2 sites in Italy
- Volunteers
- 70 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
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
Hypoxic-Ischemic Encephalopathy, Pain
Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
Management of neonatal pain and sedation often includes opioid therapy. A growing body of evidence suggests long-term harm associated with neonatal opioid exposure.
- Trial name
- DICE (NCT04772222)
- Testing
- Dexmedetomidine Hydrochloride, Morphine Sulfate
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of Utah
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
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, Birth Asphyxia
Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU)
An extension of the MIDAB trial, the MIDAB-Follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (UCM) or…
- Trial name
- MIDAB-FU (NCT03681314)
- Testing
- Umbilical Cord Milking
- Where
- 3 sites in India
- Sponsor
- Nemours Children's Clinic
Asphyxia Neonatorum
Does Placenta Pathology Predict Outcome of Neonates With Hypoxic Ischemic Encephalopathy?"
The histology of the placenta of newborn infants with perinatal asphyxia and hypoxic-ischaemic encephalopathy is analysed. There will be an evaluation if placenta could be a biomarker for neurodevelopmental outcome at 18-24…
- Trial name
- NCT03284528
- Testing
- hypothermia therapy
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- University Children's Hospital, Zurich
Severe Hypoxic-ischemic Encephalopathy
Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy
The purpose of this study is to investigate the safety and effectiveness of autologous human placental-derived stem cells (HPDSC) in combination with autologous cord blood in neonates with severe hypoxic-ischemic encephalopathy.
- Trial name
- HPDSC+HIE (NCT02434965)
- Testing
- HPDSC, Cord blood
- Where
- United States
- Sponsor
- New York Medical College
Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy
Neonatal Neurological Observation With Video AI
NeoNOVA is a multi-site, prospective, single-arm, silent observational study to determine: among (Population) infants admitted to newborn services during their inpatient hospital stay, whether (Intervention) continuous bedside…
- Conditions
- Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Sedation, Sleep
- Trial name
- NeoNOVA (NCT07628829)
- Testing
- Continuous bedside video monitoring with AI anatomic landmark tracking for neurologic monitoring
- Where
- 2 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Artemis AI Labs
Neonatal Encephalopathy, Hypoxic-ischemic Encephalopathy
Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy
This is a pilot study to test feasibility and safety of intravenous infusion of autologous umbilical cord blood cells in the first 72 hours after birth if a neonate is born with signs of encephalopathy.
- Trial name
- NCT02256618
- Testing
- Autologous umbilical cord blood cells
- Where
- 6 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Neonatal Encephalopathy Consortium, Japan
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
Neonatal Seizure, Hypoxic-Ischemic Encephalopathy
Neonatal Seizure Registry - Developmental Functional EValuation
The NSR-DEV study is a longitudinal cohort study of around 280 Neonatal Seizure Registry participants that aims to evaluate childhood outcomes after acute symptomatic neonatal seizures, as well as examine risk factors for…
- Conditions
- Neonatal Seizure, Hypoxic-Ischemic Encephalopathy, Stroke, Intracranial Hemorrhages
- Trial name
- NSR-DEV (NCT04337697)
- Where
- 9 sites in United States
- Volunteers
- 188 people
- Sponsor
- University of California, San Francisco
Hypoxic-ischemic Encephalopathy
Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy
The purpose of this study is to to evaluate the safety and efficacy of hyperbaric oxygen in term gestation newborn infants with hypoxic-ischemic encephalopathy..
- Trial name
- NCT02894866
- Testing
- hyperbaric oxygen
- Where
- 10 sites in China
- Volunteers
- 250 people
- Sponsor
- Nanfang Hospital, Southern Medical University