Clinical trials: Hypoxic-Ischemic Encephalopathy
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
Hypoxic Ischemic Encephalopathy of Newborn, Feeding Patterns
Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy
Therapeutic hypothermia (TH) is accepted worldwide as a standard of care for infants born at or beyond 36 weeks gestational age with moderate-to-severe hypoxic ischaemic encephalopathy (HIE).
- Trial name
- NCT06447155
- Testing
- Bolus feeding, Continuous feeding
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Istanbul Training and Research Hospital
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up
An extension of the CORDMILK trial, the CORDMILK follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were non-vigorous at birth and received umbilical cord milking…
- Trial name
- CORDMILK-FU (NCT03682042)
- Testing
- Umbilical Cord Milking
- Where
- 9 sites in India
- Volunteers
- 3,442 people
- Sponsor
- Nemours Children's Clinic
Encephalopathy, Hypoxic-Ischemic
PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment.
This study is a prospective, observational, single-center study to assess the correlation between rs-fMRI measures and clinical measures of standard MRI, NIRS, EEG and clinical scores.
- Trial name
- PEDI-REAVASC (NCT06370624)
- Testing
- MRI-scan
- Where
- Belgium
- Volunteers
- 30 people
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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
Darbe Administration in Newborns Undergoing Cooling for Encephalopathy
Selective head cooling or whole body hypothermia has become the standard of care for neonatal hypoxia-ischemia encephalopathy (HIE).
- Trial name
- DANCE (NCT01471015)
- Testing
- Darbepoetin alfa
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- University of Utah
Mild Birth Asphyxia, Moderate Birth Asphyxia
Olfactory Testing in Perinatal Asphyxia: Enhancing Risk Assessment
Neonatal asphyxia remains a leading cause of neurodevelopmental disabilities despite advancements in perinatal care. Hypoxic-ischemic encephalopathy (HIE), a severe outcome of asphyxia, impacts 1-3 infants per 1,000 live births…
- Trial name
- MEMOBRAIN (NCT06744244)
- Testing
- Olfactory Testing, Heart rate (HR), Heart Rate Variability (HRV), Respiratory Rate (RR), peripheral oxygen saturation (SpO2), Video-EEG
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- University of Parma
Neonatal Hypoxic Ischemic Encephalopathy
Cord Blood for Neonatal Hypoxic-ischemic Encephalopathy
This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous)umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury.
- Trial name
- NCT00593242
- Testing
- infusion of autologous cord blood, Neurodevelopmental outcomes
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Michael Cotten
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
Infant, Newborn, Hypoxia-Ischemia, Brain
Whole-Body Cooling for Birth Asphyxia in Term Infants
This large multicenter trial tested whether cerebral cooling initiated within 6 hours of birth and continued for 72 hours would reduce the risk of death and moderate to severe neurodevelopmental injury at 18-22 months corrected…
- Trial name
- NCT00005772
- Testing
- Induced hypothermia, Control
- Where
- 16 sites in United States
- Volunteers
- 208 people
- Sponsor
- NICHD Neonatal Research Network
Hypoxia-Ischemia, Brain, Heart Arrest
Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest
The objective of this study is to estimate the feasibility and safety of early weaning from ICU treatment in patients after cardiac arrest and an early (< 12 h) favourable EEG pattern (indicating no or mild postanoxic…
- Trial name
- SELECT (NCT06048796)
- Testing
- Early cessation of sedation and TTM
- Where
- 2 sites in Netherlands
- Volunteers
- 40 people
- Sponsor
- Medisch Spectrum Twente
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
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
Hypoxic Ischemic Encephalopathy of Newborn, Premature Birth
Metformin Treatment in Infants After Perinatal Brain Injury
A phase I study to test the feasibility and safety of treatment with metformin in infants affected by hypoxic ischemic encephalopathy (HIE) or prematurity-related brain injury
- Trial name
- NCT05590676
- Testing
- Metformin Hydrochloride
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- The Hospital for Sick Children
Hypoxic-Ischemic Encephalopathy
School-aged Outcomes Post Hypoxic Ischaemic Encephalopathy
Neonatal HIE increases the risk for cognitive impairments in childhood. Neonatal MRI brain scans are a strong predictor for outcome, however a normal scan has only a 35% sensitivity and 85% specificity for a normal outcome.
- Trial name
- SOPHIE (NCT07770035)
- Where
- Ireland
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- University College Cork
Hypoxic Ischaemic Encephalopathy (HIE)
EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES
To compare the survival rate and improvement in stage of hypoxic ischemic encephalopathy (HIE) at day 7 of treatment in neonates treated with versus without melatonin in addition to standard supportive therapy.
- Trial name
- NCT07305350
- Testing
- Melatonin, intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover
- Where
- Pakistan
- Volunteers
- 110 people
- Sponsor
- University of Child Health Sciences and Children's Hospital, Lahore
Anoxic Brain Injury
Safety and Efficacy Assessment of Autologous Bone-marrow Derived Adult Mesenchymal Stem Cell Therapy in Patients With Anoxic(or Hypoxic) Brain Injury Pilot Trial
The purpose of study is to evaluate the safety and efficacy of autologous bone marrow-derived stem cells therapy in patients with anaerobic (hypoxic) brain injury.
- Trial name
- NCT02210624
- Testing
- HYNR-CS inj.
- Where
- South Korea
- Volunteers
- 4 people
- Sponsor
- Hyun Young Kim
Hypoxic-Ischemic Encephalopathy
Dose Optimization of Caffeine for HIE
This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.
- Trial name
- NCT06448780
- Testing
- Caffeine citrate 20 mg/kg, Caffeine citrate 30 mg/kg
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- University of North Carolina, Chapel Hill
Anoxic Brain Injury, Cardiac Arrest
Temperature Control With an Esophageal Cooling Device in Post Cardiac Arrest Patients
This is a prospective, interventional study aiming to assess the effectiveness of the Esophageal Cooling Device (ECD) as a temperature control modality in post cardiac arrest patients.
- Trial name
- E-Chill (NCT02387775)
- Testing
- Esophageal temperature control
- Where
- 2 sites in Canada
- Volunteers
- 15 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Aquired Brain Injury, Stroke
Group-based Emotional Awareness and Expression Therapy to Support Recovery After Acquired Brain Injury: A Clinical Development and Evaluation Study
Difficulties in understanding and managing emotions may hinder recovery, rehabilitation, and participation in everyday life after acquired brain injury (ABI).
- Conditions
- Aquired Brain Injury, Stroke, MTBI - Mild Traumatic Brain Injury, mTBI
- Trial name
- NCT07852936
- Testing
- TAU + Group Therapy (EAET), Treatment as Usual (TAU)
- Where
- Sweden
- Volunteers
- 110 people
- Sponsor
- Uppsala University