Clinical trials: Neonatal Encephalopathy, open to volunteers
Neonatal Encephalopathy, Newborn Asphyxia
Cooling in Mild Encephalopathy
The goal of this randomised control trial is to establish the safety and efficacy of whole-body hypothermia for babies with mild hypoxic ischaemic encephalopathy, inform national and international guidelines, and establish…
- Trial name
- COMET (NCT05889507)
- Testing
- Whole body hypothermia, Targeted normothermia, Supportive neonatal intensive care
- Where
- 39 sites in Italy, United Kingdom
- Volunteers
- 426 people
- Sponsor
- Imperial College London
Anoxia-Ischemia, Brain, Neonatal Encephalopathy
Neonate Cerebral Activity in Immediate Post Partum
Neonatal anoxia-ischemia causes significant neurodevelopmental disorders. In this study the investigators want to better understand the interactions between the nervous and the hemodynamic cerebral systems during the adaptation…
- Trial name
- POSTPARTUM (NCT04225975)
- Testing
- electroencephalogram, oxymetry
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Newborn Asphyxia
Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy
Therapeutic hypothermia (TH) is the standard of care for newborns with moderate to severe hypoxic-ischaemic encephalopathy (HIE) born at 35 weeks or more of gestation.
- Trial name
- NCT06394453
- Testing
- enteral feeding with mother milk or human donor breast milk
- Where
- Poland
- Volunteers
- 104 people
- Sponsor
- Nutricia Foundation
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
Preterm Less Than 32wks With IVH, WMI/PVL, Late Preterm or Term (37-42wks) With Neonatal Encephalopathy Treated With Hypothermia for HIE
Cerebral/ Cortical Visual Impairment: Screening, Identification and Outcome Prediction in Neonates
Cerebral/Cortical Visual Impairment (CVI) is the leading cause of childhood visual impairment in the United States and other industrialized countries.
- Trial name
- CVI (NCT07275021)
- Testing
- Prospective Clinical and Neurodevelopmental Data Collection
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Brigham and Women's Hospital
Hypoxic Ischemic Encephalopathy of Newborn, Hyperglycemia
Continuous Glucose Monitoring in HIE
The aim of the study is to examine whether the use of continuous glucose monitoring (CGM) to guide the clinical management of glycaemic control will result into an increased time in the target glucose concentration.
- Conditions
- Hypoxic Ischemic Encephalopathy of Newborn, Hyperglycemia, Hypoglycemia
- Trial name
- NCT06563687
- Testing
- Dexcom ONE+
- Where
- 3 sites in Italy
- Volunteers
- 70 people
- Sponsor
- University of Campania Luigi Vanvitelli
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
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
Congenital Portosystemic Shunt, CPSS (Congenital Portosystemic Shunt)
International Registry of Congenital Portosystemic Shunt (IRCPSS)
Congenital Portosystemic Shunt (CPSS) is a rare condition important by the multiplicity and severity of associated complications.
- Trial name
- IRCPSS (NCT06041906)
- Testing
- Shunt Closure
- Where
- 26 sites in United States, Australia and 14 more
- Volunteers
- 500 people
- Sponsor
- Prof. Valérie Mc Lin
Hypoxic Brain Damage, Hypoxic Ischaemic Encephalopathy (HIE)
Intranasal AAV9-PHP.eB Gene Therapy in Cerebral Palsy (CP) & Hypoxic Ischemic Encephalopathy (HIE)
This international study, organized by Healing Hope International, is an observational registry designed to collect real-world data on participants living with chronic hypoxic ischemic encephalopathy (HIE) who receive an emerging…
- Conditions
- Hypoxic Brain Damage, Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischaemic Encephalopathy Due to Cardiac Arrest, Hypoxic Ischemic Encephalopathy of Newborn
- Trial name
- GEN-HOPE (NCT07264166)
- Where
- Mexico
- Volunteers
- 25 people
- Sponsor
- Healing Hope International
Hypoxic-Ischaemic Encephalopathy, Neonatal Encephalopathy
Intranasal Breast Milk Therapy in HIE
This is an open-label prospective single-center randomized controlled trial to evaluate the effect of intranasal breast milk in hypoxic-ischemic encephalopathic neonates receiving therapeutic hypothermia on long term…
- Conditions
- Hypoxic-Ischaemic Encephalopathy, Neonatal Encephalopathy, Perinatal Asphyxia, Neonatal Hypoxic Ischemic Encephalopathy
- Trial name
- NEO-BRIGHT (NCT06746532)
- Testing
- Intranasal breast milk
- Where
- Hungary
- Volunteers
- 80 people
- Sponsor
- Semmelweis University
Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD)
Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders
This observational study evaluates functional and developmental outcomes in pediatric participants undergoing a two week intensive multimodal neurorehabilitation program.
- Conditions
- Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD), Neurodevelopmental Disorders and Developmental Abnormalities, Developmental Delay (Disorder)
- Trial name
- GEN-HOPE (NCT07493096)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Healing Hope International
Oxidative Phosphorylation Deficiencies, Electron Transport Chain Disorders, Mitochondrial
The NIH MINI Study: Metabolism, Infection, and Immunity in Inborn Errors of Metabolism
The Metabolism, Infection and Immunity (MINI) Study is a longitudinal natural history study at the National Institutes of Health (NIH) that aims to define the relationship between infection, immunity and clinical decline in…
- Conditions
- Oxidative Phosphorylation Deficiencies, Electron Transport Chain Disorders, Mitochondrial, Mitochondrial Disorders, Leigh Disease
- Trial name
- NCT01780168
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- National Human Genome Research Institute (NHGRI)
Encephalopathy
This Multicentre Study Compares aCUP-E With Standard Electrodes During aEEG Monitoring in NICU Newborns at Risk of Encephalopathy, Assessing Recording Quality, Reliability, Ease of Use and Safety.
This multicentre, observational, prospective and comparative study aims to validate the use of the new aCUP-E electrode for aEEG monitoring in newborns admitted to the NICU, comparing it with conventional electrodes currently…
- Trial name
- aCUP HUSJR/J23 (NCT07923227)
- Volunteers
- 35 people
- Sponsor
- Institut Investigacio Sanitaria Pere Virgili
Neonates and Preterm Infants, Neonates or Premature Babies
Prospective Study of the Feasibility of Brain Connectivity Imaging by Functional Ultrasound Imaging (fUS) in Newborn Infant
Neurodevelopmental disorders (NDD) affect how the brain develops and can lead to lifelong difficulties with movement, learning, behavior, and thinking.
- Trial name
- CONEXUS (NCT06940713)
- Testing
- Imaging Time
- Where
- France
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Epileptic Encephalopathy
Creation of a Register of Patients With Neonatal-onset Epileptic Encephalopathy
Electrical activity emerges in the third trimester of pregnancy, plays an important role in the construction of cortical maps, and is impaired in patients with severe early epileptic encephalopathies (EOEE).
- Trial name
- IMPROVE (NCT04802135)
- Testing
- Survey
- Where
- 15 sites in France
- Volunteers
- 200 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
HIE - Hypoxic - Ischemic Encephalopathy, Perinatal Anoxic-ischemic Brain Injury
Biomarkers Study in Infants With Prior Neonatal Brain Injury
This research focuses on the long-term cognitive development of children, including healthy infants and those who had a perinatal brain injury.
- Conditions
- HIE - Hypoxic - Ischemic Encephalopathy, Perinatal Anoxic-ischemic Brain Injury, Premature Birth, Healthy Participants
- Trial name
- NCT07413900
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Encephalopathy, Erythropoietin
Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial)
One million babies die, and at least 2 million survive with lifelong disabilities following neonatal encephalopathy (NE) in low and middle-income countries (LMICs), every year.
- Conditions
- Encephalopathy, Erythropoietin, Newborn Asphyxia
- Trial name
- EMBRACE (NCT05395195)
- Testing
- Erythropoietin, Supportive neonatal intensive care
- Where
- 10 sites in Bangladesh, India and 1 more
- Volunteers
- 504 people
- Sponsor
- Imperial College London
Neonatal Encephalopathy
Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia
Around the time of birth, some babies experience a condition called asphyxia, which means that their brain and other organs do not receive enough blood and/or oxygen to work properly.
- Trial name
- NCT06098833
- Testing
- Sildenafil, Ora-Blend
- Where
- 3 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Pia Wintermark
Leigh Syndrome, Leigh Disease
The International Registry for Leigh Syndrome
The purpose of this study is to develop a database containing clinical and laboratory information for patients with Leigh syndrome.
- Conditions
- Leigh Syndrome, Leigh Disease, Leigh's Necrotizing Encephalopathy, Subacute Necrotizing Encephalomyopathy
- Trial name
- NCT03137355
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- The University of Texas Health Science Center, Houston