Clinical trials: Perinatal Brain Injury
Infant Development, Perinatal Stroke
Behavioral Assessment Method Index
The overall goal of this study is to develop and improve assessment methods for children with and without perinatal arterial ischemic stroke (PAS)/hemiparetic cerebral palsy (HCP).
- Conditions
- Infant Development, Perinatal Stroke, Hemiparesis, Cerebral Palsy
- Trial name
- BAM (NCT07291479)
- Testing
- Non interventional study
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Ohio State University
Perinatal Brain Injury, Healthy Participants
Sparking Potential, Revealing Infant Neurocognitive Traits
This research focuses on the long-term cognitive development of children, including healthy infants and those who had a perinatal brain injury. As part of this research study, children complete virtual game and assessments.
- Trial name
- SPRINT (NCT07390136)
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
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
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
Cerebral Visual Impairment, Refractive and Accommodative Disorders
Babies in Glasses; a Feasibility Study.
This is a feasibility study to begin investigating the possibility that early use of near vision glasses will improve vision in infants at risk of Cerebral Visual Impairment (CVI), leading to further improvement in other areas of…
- Conditions
- Cerebral Visual Impairment, Refractive and Accommodative Disorders, Hypoxic-Ischemic Encephalopathy, Premature Birth
- Trial name
- BiG (NCT05048550)
- Testing
- Near vision spectacles
- Where
- United Kingdom
- Volunteers
- 55 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
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
Perinatal White Matter Brain Injury
MR Imaging of Perinatal Brain Injury
The purpose of this study is to collect and compare information from cranial ultrasounds, magnetic resonance imaging scans, neurological exam and neuropsychological assessments of children.
- Trial name
- NCT02008045
- Testing
- Magnetic Resonance Imaging, Neurodevelopmental Testing
- Where
- United States
- Volunteers
- 557 people
- Sponsor
- University of Pittsburgh
Cerebral Palsy
FES in Young Children With Perinatal Stroke
Every year about 1 out of every 1,600-5,000 infants has a stroke around the time of birth. Many of these children will have lifelong physical problems. For example, the arm muscles are often paralyzed.
- Trial name
- NCT02975180
- Testing
- FES, Conventional
- Where
- Canada
- Volunteers
- 11 people
- Sponsor
- University Health Network, Toronto
Apgar; 0-3 at 1 Minute, Metabolic Acidosis
Autologous Stem Cells in Newborns With Oxygen Deprivation
The purpose of this study is to determine whether the plasticity of autologous intravenous application of cord blood stem cells would improve the clinical course of asphyxiated newborns.
- Conditions
- Apgar; 0-3 at 1 Minute, Metabolic Acidosis, Hypoxia, Brain, Multiple Organ Failure
- Trial name
- NCT01506258
- Testing
- Application of Stem Cells, Observation
- Where
- Mexico
- Volunteers
- 20 people
- Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
Perinatal Stroke, Hypoxic-ischemic Encephalopathy
Protein Supplementation in Infants With Brain Injury
To date, few studies have been done regarding nutrition supplementation in infants with brain injury. Therefore, the investigators are proposing to study the effects of protein supplementation in this group of babies.
- Conditions
- Perinatal Stroke, Hypoxic-ischemic Encephalopathy, White Matter Injury
- Trial name
- NCT01936246
- Testing
- Increased protein
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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
Encephalopathy, Hypoxic-Ischemic, Infant, Newborn, Diseases
Effect of Allopurinol for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome
Neonatal hypoxic-ischemic encephalopathy (HIE) is a major cause of death or long-term disability in infants born at term in the western world, affecting about 1-4 per 1.000 life births and consequently about 5-20.000 infants per…
- Trial name
- ALBINO (NCT03162653)
- Testing
- Allopurinol, Mannitol
- Where
- 12 sites in Austria, Belgium and 10 more
- Volunteers
- 760 people
- Sponsor
- University Hospital Tuebingen
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
Perinatal Anoxic-ischemic Brain Injury
Hypothermia Enhanced by Magnesium Sulphate
New 2010 neonatal resuscitation guidelines state that offering therapeutic hypothermia (TH) should be a standard of care in managing neonates with perinatal hypoxic - ischemic insult and present with signs of moderate and/or…
- Trial name
- Hemen (NCT02499393)
- Testing
- Magnesium Sulfate
- Where
- Poland
- Volunteers
- 75 people
- Sponsor
- Polish Mother Memorial Hospital Research Institute
Hypoxic-Ischemic Encephalopathy
Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy
The purpose of this study is to determine whether nerve growth factor (cerebrolysin®) therapy will improve the psychomotor outcome in infants with moderate and severe hypoxic ischemic encephalopathy after hospital discharge.
- Trial name
- CerebroHIE (NCT01059461)
- Testing
- Cerebrolysin®
- Where
- 2 sites in Egypt
- Volunteers
- 40 people
- Sponsor
- Sahar M.A. Hassanein, MD
Cerebral Palsy, Perinatal Stroke
Single-session tDCS in Cerebral Palsy
The goal of this study is to characterize individual responses to a single application of transcranial direct current stimulation (tDCS) in children with unilateral cerebral palsy (UCP), and to test which electrode configuration…
- Conditions
- Cerebral Palsy, Perinatal Stroke, Periventricular Leukomalacia
- Trial name
- NCT03635775
- Testing
- Active tDCS
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
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
Perinatal Brain Injury
Neuro-MoD: Neuroplasticity With Motor Development
This study is for infants and toddlers between 8 and 24 months old who use one arm and/or hand differently following a perinatal brain injury.
- Trial name
- NCT07738432
- Testing
- Constraint-Induced Movement Therapy (CIMT), Transcutaneous auricular vagus nerve stimulation (taVNS)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of Wisconsin, Madison
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 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