Clinical trials: Hypoxic-Ischemic Encephalopathy, Neonatal
Hypoxic Ischaemic Encephalopathy
Xenon and Cooling Therapy in Babies at High Risk of Brain Injury Following Poor Condition at Birth
This study examines the effect of inhaled xenon gas in the treatment of newborn infants with hypoxic-ischemic encephalopathy (HIE) in combination with cooling, which is the standard treatment for this condition.
- Trial name
- CoolXenon2 (NCT01545271)
- Testing
- xenon gas, Whole body cooling
- Where
- United Kingdom
- Volunteers
- 32 people
- Sponsor
- University Hospitals Bristol and Weston NHS Foundation Trust
Periventricular Leukomalacia, White Matter Disease
Cell-Based Therapy for White Matter Repair in Periventricular Leukomalacia
The goal of this study is to explore a new treatment that may help repair brain damage in individuals with periventricular leukomalacia (PVL), a condition that affects white matter in the brain.
- Conditions
- Periventricular Leukomalacia, White Matter Disease, Hypoxic-Ischemic Encephalopathy, Demyelinating Diseases
- Trial name
- NCT06985303
- Testing
- Investigational Combination Product
- Sponsor
- MGAM LLC
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
HIE - Perinatal Hypoxic - Ischemic Encephalopathy
NVD in Hypothermic HIE Neonates
Neonatal hypoxic ischemic (HI) injury is an unpredictable neurologic injury with devastating, long term consequences for parents who are expecting a normal child.
- Trial name
- NCT04643821
- Testing
- N-acetylcysteine, NAC, and calcitriol
- Volunteers
- 30 people
- Sponsor
- Medical University of South Carolina
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 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
Mild Hypoxic Ischemic Encephalopathy of Newborn
Cool Prime Comparative Effectiveness Study for Mild HIE
To determine effectiveness of therapy to improve neurodevelopmental outcomes in infants with mild HIE. To determine the adverse effects of Therapeutic Hypothermia (TH) in mild HIE on the neonate and his/her family.
- Trial name
- COOLPRIME (NCT04621279)
- Testing
- Normothermia, Whole body therapeutic hypothermia
- Where
- United States
- Volunteers
- 460 people
- Sponsor
- University of Texas Southwestern Medical Center
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
Brain Injuries, Congenital Heart Disease
Protecting Brains and Saving Futures - the PBSF Protocol
Background: Multiple neonatal disorders are associated with risks of neurological injury. Thus, management of these infants should involve a coordinated approach to permit early diagnosis with improved clinical care.
- Conditions
- Brain Injuries, Congenital Heart Disease, Newborn Morbidity, Intraventricular Hemorrhage
- Trial name
- PBSF (NCT03786497)
- Where
- 2 sites in Brazil
- Volunteers
- 2,268 people
- Sponsor
- Protecting Brains Saving Futures
Hypoxic-Ischaemic Encephalopathy, Perinatal Asphyxia
Hypoxic-Ischemic Encephalopathy Therapy Optimization in Neonates for Better Neuroprotection With Inhalative CO2
This is a Phase I, open-label, single center trial to evaluate the feasibility and safety of low concentration CO2 gas mixture (5% CO2 + 95% air) inhalation in asphyxiated, cooled, mechanically ventilated newborns at risk of…
- Conditions
- Hypoxic-Ischaemic Encephalopathy, Perinatal Asphyxia, Hypocapnia
- Trial name
- HENRIC (NCT02700854)
- Testing
- 5% carbon-dioxide inhalation
- Where
- Hungary
- Volunteers
- 10 people
- Sponsor
- Semmelweis University
Music Therapy, Pain
Music Therapy During Hypothermia in the NICU
Background: Hypoxic-ischemic encephalopathy (HIE) is a neurological condition caused by poor oxygenation during the peripartum period.
- Conditions
- Music Therapy, Pain, Allodynia, Neonates
- Trial name
- NCT06951269
- Testing
- Live entrained music therapy
- Where
- Colombia
- Volunteers
- 22 people
- Sponsor
- Fundación Santa Fe de Bogota
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
Neonatal Hypoxic Ischemic Encephalopathy
Neonatal Hypoxic Ischemic Encephalopathy:Early Diagnosis and Management of Comorbidities
Perinatal asphyxia is common cause of acquired neonatal brain injury in neonates associated with hypoxic-ischemic encephalopathy, leading to long-term neurologic complication or death.
- Trial name
- NCT03550612
- Testing
- magnetic resonant imaging,cranial ultrasound., Amplitude integrated electroencephalogram
- Volunteers
- 100 people
- Sponsor
- Assiut University
Neonatal Hypoxic Ischemic Encephalopathy
Antenatal and Intrapartum Risk Factors Associated With Neonatal Hypoxic Ischemic Encephalopathy
Perinatal asphyxia is a major cause of hypoxic Ischemic encephalopathy (HIE), perinatal death and long term neurodisability. This can be devastating for the individual and their family; the healthcare and litigation costs…
- Trial name
- NCT04364932
- Volunteers
- 100 people
- Sponsor
- Assiut University
Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns
A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy
This study will test the safety and efficacy of an infusion of a baby's own (autologous) umbilical cord blood as compared with placebo in babies born with history and signs of hypoxic-ischemic brain injury.
- Trial name
- (HIE) (NCT02612155)
- Testing
- Infusion of autologous cord blood
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Michael Cotten
Hypoxic-Ischemic Encephalopathy, Acute Kidney Injury
Renal and Cerebral NIRS and Early Acute Kidney Injury in Cooled Neonates With Birth Asphyxia
This prospective, single-center observational cohort study evaluated whether continuous cerebral and bilateral renal near-infrared spectroscopy (NIRS) monitoring during therapeutic hypothermia distinguishes term neonates with…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Neonatal, Asphyxia Neonatorum
- Trial name
- NCT07743099
- Testing
- 1- Continuous Cerebral Near-Infrared Spectroscopy, 2- Continuous Bilateral Renal Near-Infrared Spectroscopy
- Where
- Turkey (Türkiye)
- Volunteers
- 46 people
- Sponsor
- Agah Bahadır Öztürk,MD
Cerebral Palsy, Hypoxic-Ischemic Encephalopathy
Therapeutic Intervention Supporting Development From NICU to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy
The purpose of this study is to evaluate the feasibility and begin to evaluate the effect of a sensorimotor intervention (SMI) provided in the first 6 months of life for infants with hypoxic-ischemic encephalopathy.
- Trial name
- NCT05130528
- Testing
- Sensorimotor Intervention
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- University of Southern California
Birth Asphyxia
First-day High Dose Vitamin C, E in Severe Birth Asphyxia
To study the role of first-day high dose oral vitamin C and first-day single high dose oral vitamin E in hypoxic-ischemic encephalopathy in newborns, in the reduction of morbidity and adverse neurodevelopmental sequelae.
- Trial name
- CEBA (NCT01743742)
- Testing
- Vitamin E, Vitamin C
- Where
- India
- Volunteers
- 95 people
- Sponsor
- Sir Takhtasinhji General Hospital
Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy
Healthy Little Eyes
The purpose of this research study is to gather more information on how eye injury is related to a baby's future development and see if eye function and brain test results can be used, along with current measures, to better…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy, Encephalopathy
- Trial name
- NCT05971446
- Testing
- Visual Evoked Potential (VEP), Electroretinogram (ERG)
- Where
- United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Perinatal Stroke
Baby Brain Recovery Study
This study will be a longitudinal multiple-visit observational study, done to identify possible bioindicators of recovery and repair of motor corticospinal pathways which may be targeted by future interventions in infants with…
- Trial name
- NCT05013736
- Testing
- Magnetic Resonance Imaging, Behavioral Assessments, Non invasive Transcranial Magnetic Stimulation
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- University of Wisconsin, Madison