Clinical trials: Neonatal Encephalopathy
Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischemic Encephalopathy of Newborn
Feasibility and Safety of Intranasally Administered Breast Milk in HIE
This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.
- Conditions
- Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy, Neonatal Hypoxic Ischemic Encephalopathy
- Trial name
- F-NEO-BRIGHT (NCT06747260)
- Testing
- Intranasal breast milk
- Where
- Hungary
- Volunteers
- 10 people
- Sponsor
- Semmelweis 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
Hypoxic-Ischemic Encephalopathy, Hepatitis B Vaccination
Hypothermia's Effect on Hepatitis B Vaccination
The purpose of the research is to determine if the Hepatitis B vaccine after birth provides enough protection after cooling for Hypoxic Ischemic Encephalopathy (HIE).
- Conditions
- Hypoxic-Ischemic Encephalopathy, Hepatitis B Vaccination, Hypothermia, Newborn
- Trial name
- NCT05787899
- Testing
- Hypothermia Protocol
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Medical University of South Carolina
MELAS Syndrome, Lebers Hereditory Optic Neuropathy With Extra Ocular Symptoms (LHON-Plus)
A Basket Clinical Study to Assess Glycerol Tributyrate in Patients With Mitochondrial Encephalopathy, Lactic Acidosis, Stroke-like Episodes (MELAS) or Leber's Hereditary Optic Neuropathy-Plus (LHON-Plus)
This is a parallel arm non-randomized dose-escalation, open-label basket exploratory phase 1 clinical trial where Mitochondrial encephalopathy, lactic acidosis, stroke-like episodes (MELAS) and Leber's hereditary optic…
- Trial name
- NCT06792500
- Testing
- Glycerol Tributyrate
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- George Washington University
Hepatic Encephalopathy, Urea Cycle Disorders
A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group
The purpose of this study is to determine the safety and tolerability of GT4P administered orally as a single dose, and twice daily for 7 consecutive days, to subjects with hepatic impairment with cirrhosis (Child-Pugh scores of…
- Trial name
- NCT00986895
- Testing
- HPN-100
- Where
- 2 sites in Ukraine
- Volunteers
- 32 people
- Sponsor
- Amgen
HIE, Hypoxic-Ischemic Encephalopathy
Hydrogen In Neonatal Encephalopathy (HIE) Trial
Despite advances in neonatal care, moderate-to-severe acute perinatal HIE in late preterm and term infants remains a cause of mortality, neurological injury, and long-term neurodevelopmental disability.
- Trial name
- NCT07411911
- Testing
- Hydrogen Gas (H2)
- Volunteers
- 54 people
- Sponsor
- Boston Children's Hospital
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
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
Hypoxic Ischemic Encephalopathy
Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy
The hypothesis is that premature infants' can have enough cooling applied to cool their brain to decrease CNS injury without cooling their body.
- Trial name
- NCT00620711
- Testing
- Olympic Cool Cap
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Vanderbilt University
Asphyxia Neonatorum, Hypoxia
TOBY (TOtal Body hYpothermia): a Study of Treatment for Perinatal Asphyxia
Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial encephalopathy reduces death and severe neurodevelopmental disability.
- Conditions
- Asphyxia Neonatorum, Hypoxia, Encephalopathy, Seizures
- Trial name
- NCT00147030
- Testing
- Whole body mild induced hypothermia
- Where
- United Kingdom
- Volunteers
- 325 people
- Sponsor
- Imperial College London
Hypoxic-Ischemic Encephalopathy Mild, Neonatal Encephalopathy
TIME Study: Therapeutic Hypothermia for Infants With Mild Encephalopathy
The TIME study is a randomized, controlled trial to evaluate impact on early measures of neurodevelopment and the safety profile of therapeutic hypothermia in term neonates with Mild Hypoxic-Ischemic Encephalopathy who are < 6…
- Trial name
- TIME (NCT04176471)
- Testing
- Therapeutic Hypothermia, Normothermia
- Where
- 5 sites in United States
- Volunteers
- 68 people
- Sponsor
- Stanford University
Hypoxic-Ischemic Encephalopathy
Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy
The purpose of this study is to investigate the effectiveness and safety of selective head cooling (SHC) in neonatal hypoxic-ischemic encephalopathy (HIE).
- Trial name
- NCT00890409
- Testing
- Cooling cap (YJW608-04B)
- Where
- China
- Volunteers
- 256 people
- Sponsor
- Fudan University
Hypoxic Encephalopathy, Birth Asphyxia
Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates
Studying the effect of passive versus Blanket roll III modality of therapeutic hypothermia (TH)on myocardial function of asphyxiated neonates through using tissue Doppler (TD).
- Conditions
- Hypoxic Encephalopathy, Birth Asphyxia, Neonatal Encephalopathy, Hypothermia, Newborn
- Trial name
- NCT05652738
- Testing
- Passive cooling application, cooling using Blanket roll III
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Alexandria University
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
Neonatal Seizures
NEMO1:NEonatal Seizure Using Medication Off-patent
NEMO is a multicentre pan European clinical trial with the aim to develop new treatment strategies for the treatment of neonatal seizures using the loop diuretic bumetanide.
- Trial name
- NEMO1 (NCT01434225)
- Testing
- Bumetanide
- Where
- 7 sites in Ireland, Netherlands and 2 more
- Volunteers
- 14 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
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, Umbilical Cord Milking
Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy
The objective of this pilot study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth.
- Trial name
- NCT02287077
- Testing
- Umbilical Cord Milking
- Where
- India
- Volunteers
- 101 people
- Sponsor
- Thomas Jefferson University
Neonatal Seizure, Hypoxic-Ischemic Encephalopathy
Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy
The NSR-GENE study is a longitudinal cohort study of approximately 300 parent-child trios from the Neonatal Seizure Registry and participating site outpatient clinics that aims to evaluate whether and how genes alter the risk of…
- Conditions
- Neonatal Seizure, Hypoxic-Ischemic Encephalopathy, Stroke, Intracranial Hemorrhage
- Trial name
- NSR-GENE (NCT05361070)
- Where
- 8 sites in United States
- Volunteers
- 300 people
- Sponsor
- University of California, San Francisco
Hypoxic Ischemic Encephalopathy
Radiological Evaluation of Hypoxic Ischemic Encephalopathy
To compare between Transcranial Ultrasound , MRI and CT in patients with Hypoxic Ischemic Encephalopathyas regards diagnostic accuracy and prognostic value .
- Trial name
- NCT06145256
- Testing
- MRI brain, MSCT brain, Transcranial Ultrasound
- Volunteers
- 48 people
- Sponsor
- Assiut University
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