Clinical trials: Perinatal Brain Injury
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
Cerebral Palsy, Perinatal Stroke
Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture
The purpose of the study is to assess implementation and effectiveness of a caregiver-delivered rehabilitation intervention for infants and toddlers with cerebral palsy.
- Trial name
- HEIGHTEN (NCT05346887)
- Testing
- Home-based Therapy
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- University of Calgary
Hypoxia Ischemia, Cerebral, Hypoxia-Ischemia, Brain
Functional Imaging of Baby Brains
Infants are at risk of developing motor and cognitive neurodevelopmental disabilities as a sequelae to hypoxic-ischemic brain injury during the perinatal period.
- Conditions
- Hypoxia Ischemia, Cerebral, Hypoxia-Ischemia, Brain, Hypoxia Neonatal, Hypoxic-Ischemic Encephalopathy
- Trial name
- FIBB (NCT05514665)
- Testing
- Diffuse Optical Tomography
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- Hamilton Health Sciences Corporation
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
Asphyxia Neonatorum
Biomarkers And Neurological Outcome in Neonates 2
Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data in a human population for their…
- Trial name
- BANON2 (NCT04714775)
- Where
- 13 sites in Germany, Turkey (Türkiye)
- Volunteers
- 500 people
- Sponsor
- InfanDx AG
Arterial Ischemic Stroke (AIS) in Children
Umbilical Cord Blood in the Treatment of Stroke in Children.
The specific aims of this study are: 1. To determine if Human Umbilical Cord Blood (hUCB) infusion is safe in children with perinatal arterial ischemic stroke (AIS). 2.
- Trial name
- Pedi Stroke (NCT01700166)
- Testing
- Autologous Human Cord Blood derived Stem Cell injection
- Where
- United States
- Sponsor
- Aryn Knight
Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia
Intranasal Stem Cells to Treat Perinatal Brain Injury to Combat Cerebral Palsy
Hypoxic-ischemic brain injury (HIBI) is a leading cause of death and lifelong disability in near-term and term infants, most often caused by perinatal arterial ischemic stroke (PAIS, incidence approximately 1:5000 live births) or…
- Conditions
- Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia, Hypoxic-Ischemic Brain Injury, PAIS
- Trial name
- iSTOP-CP (NCT07831746)
- Testing
- MSC, marrow
- Volunteers
- 162 people
- Sponsor
- UMC Utrecht
Infant, Extremely Premature, Brain Injuries
Safeguarding the Brain of Our Smallest Infants Phase III
the SafeBoosC-III trial investigates the benefit and harms of treatment based on near-infrared spectroscopy monitoring compared with treatment as usual.
- Conditions
- Infant, Extremely Premature, Brain Injuries, Death, Brain, Death; Neonatal
- Trial name
- SafeBoosC (NCT03770741)
- Testing
- Modify cardio-respiratory support to avoid cerebral hypoxia, Treatment as usual
- Where
- Denmark
- Volunteers
- 1,601 people
- Sponsor
- Gorm Greisen
Sequelae of Perinatal Brain Injury
Efficacy and Safety Clinical Trial of Tenoten for Children Liquid Dosage Form Therapy in Infants With Sequelae of Perinatal Brain Injury
Purpose of the study: To assess the clinical efficacy of Tenoten for children liquid dosage form therapy (10 oral drops per day for 12 weeks) in Infants with Sequelae of Perinatal Brain Injury (mild-to-moderate cerebral…
- Trial name
- NCT03159611
- Testing
- Tenoten for children
- Where
- 10 sites in Russia
- Volunteers
- 182 people
- Sponsor
- Materia Medica Holding
Perinatal Stroke
Intensive Motor Training After Perinatal Stroke to Enhance Walking
Early childhood injuries such as perinatal (around birth) stroke are devastating because the child lives with the problem for life, typically close to a normal lifespan.
- Trial name
- NCT01773369
- Testing
- Early leg training, Delayed leg training, Parent leg training
- Where
- 2 sites in Canada
- Volunteers
- 33 people
- Sponsor
- University of Alberta
Premature Birth, NEUROPROTECTION
Magnesium Sulphate Neuroprotective Strategies for Preterm Deliveries
A Cochrane systematic review has confirmed that fetal exposure to magnesium sulphate given before preterm birth has a neuroprotective role.
- Conditions
- Premature Birth, NEUROPROTECTION, MAGNESIUM SULPHATE, Cerebral Palsy
- Trial name
- NCT05674565
- Testing
- Magnesium sulfate loading with maintenance dose, Magnesium sulfate loading dose only
- Where
- Egypt
- Volunteers
- 336 people
- Sponsor
- Zagazig University
Dyskinetic Cerebral Palsy Due to Perinatal Hypoxia
Effect of DBS on Quality of Life in Dyskinetic Cerebral Palsy
There are limited therapeutical options for patients with secondary dystonia due to cerebral palsy. Pharmacotherapy is often without effect, or side effects are severe.
- Trial name
- STIM-CP (NCT02097693)
- Where
- Germany
- Volunteers
- 16 people
- Sponsor
- University Hospital of Cologne
Cerebral Palsy
Optic Discs in Children With Cerebral Palsy
Hypothesis: Children born prematurely (between 8 and 9 months) with brain damage have an abnormal appearance of the optic nerve (nerve in eye) that resembles glaucoma (cupping) compared to those born before 8 months.
- Trial name
- NCT00769197
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- University of Mississippi Medical Center
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
Cerebral Palsy, Hypoxic-Ischemic Encephalopathy
Early Virtual Intervention for Infants With CP Following HIE Diagnosis
This will be a five year study that will be a prospective, randomized, controlled trial (RCT) to assess the effect of a virtual early intervention care delivery model in the provision of therapy to enhance the neurodevelopmental…
- Conditions
- Cerebral Palsy, Hypoxic-Ischemic Encephalopathy, Brain Injuries, Perinatal Hypoxia
- Trial name
- RECOVER (NCT04913324)
- Testing
- Virtual Care
- Where
- Canada
- Volunteers
- 150 people
- Sponsor
- The Hospital for Sick Children
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- 2 sites in United States, Australia
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Infant, Newborn, Infant, Low Birth Weight
Inflammatory Cytokines Associated With Perinatal Brain Injury
This observational study assessed whether measurements of certain pro-inflammatory and anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up to day of life 21 can predict cerebral palsy at…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Cytokines (NCT01035697)
- Where
- 18 sites in United States
- Volunteers
- 1,067 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy
Dexmedetomidine Versus Morphine During Cooling Therapy in Neonates
About ~3/ 1000 live-born newborns may suffer from brain injury due to a transient drop in oxygen supply to the brain during the birth process.
- Conditions
- Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy, Perinatal Anoxic-ischemic Brain Injury
- Trial name
- COOL-SED (NCT06985290)
- Testing
- Dexmedetomidine Infusion, Morphine Infusion
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Ipsita Goswami
Asphyxia Neonatorum
Biomarkers And Neurological Outcome in Neonates (BANON)
Validation of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies and a preliminary human study.
- Trial name
- NCT03357250
- Where
- 11 sites in Germany
- Volunteers
- 553 people, healthy volunteers welcome
- Sponsor
- Life Science Inkubator
Encephalopathy, Asphyxia Newborns
Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury
The purpose of this study is early identification of asphyxiated newborns through eeg starting in the delivery room.
- Trial name
- NCT02445417
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Sharp HealthCare