Clinical trials: Perinatal Brain Injury
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
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
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
Stroke, Cerebral Palsy
Modulation of Brain Plasticity After Perinatal Stroke
Newborn stroke is the leading cause of a common type of cerebral palsy (CP) that affects thousands of Canadian children and families.
- Trial name
- PLASTIC CHAMPS (NCT01189058)
- Testing
- Repetitive Transcranial Magnetic Stimulation (rTMS), Constraint-induced movement therapy (CIMT)
- Where
- Canada
- Volunteers
- 64 people
- Sponsor
- University of Calgary
Perinatal Hypoxia
Serum Erythropoietin Level in Perinatal Asphyxia
This study is to evaluate brain and kidney injuries in full-term neonates with perinatal asphyxia by detecting specific biomarker in blood (Erythropoietin).
- Trial name
- NCT05018364
- Testing
- Serum erythropoietin level
- Where
- Egypt
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Cairo University
Perinatal Stroke, Cerebral Palsy
Enhancing Motor Plasticity After Perinatal Stroke Using tDCS
The purpose of this study is to test tDCS (transcranial direct current stimulation), a type of non-invasive brain stimulation, to determine whether it can improve motor function in children with perinatal stroke and hemiparesis.
- Trial name
- tDCS (NCT02170285)
- Testing
- Interventional TDCS
- Where
- Canada
- Volunteers
- 23 people
- Sponsor
- University of Calgary
HIE - Perinatal Hypoxic - Ischemic Encephalopathy
The Ability of NIRS to Predict Brain Injury in Hypoxic Ischemic Encephalopathy
A longitudinal study evaluating the predictive ability of near infrared spectroscopy to predict brain injury in infants with hypoxic ischemic encephalopathy.
- Trial name
- NCT03835039
- Testing
- NIRS
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Albany Medical College
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
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
Parent Therapist Partnership to Provide Early, Intensive Exercise in Perinatal Stroke
A prospective, single blind, parallel group, randomized control trial to determine if early, intensive lower extremity activity delivered by a physical therapist and a parent in partnership improves gross motor function more than…
- Trial name
- NCT03672864
- Testing
- Intensive exercise
- Where
- 3 sites in Canada
- Volunteers
- 18 people
- Sponsor
- University of Alberta
Infant, Premature, Erythropoietin
High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
The highest risk for perinatal brain injury occurs among extremely premature infants who weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible, associated with neurodevelopmental disability…
- Conditions
- Infant, Premature, Erythropoietin, Brain Injury, Intraventricular Hemorrhage
- Trial name
- NCT00589953
- Testing
- Erythropoietin
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Atlantic Health System
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
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
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
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
Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy
Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
The purpose of this study is to improve the ability of the investigators to monitor brain health in newborn babies at risk of brain injuries.
- Trial name
- NCT02793999
- Testing
- Near-Infrared Spectroscopy (NIRS)
- Where
- 3 sites in United States
- Volunteers
- 125 people
- Sponsor
- Boston Children's Hospital
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
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
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