Clinical trials: Perinatal Brain Injury
Parents of Preterm Infants Born Before 33 Weeks Gestation
PPrime: Parents Views on Diagnosis and Information-giving in Neonatal Care (Pilot Study)
The aim of the pilot study is to explore and identify the issues of concern to parents whose babies have been cared for in a neonatal unit and exposed to imaging, its influence on diagnosis and information-giving process
- Trial name
- PPrime (NCT01055548)
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Imperial College London
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
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
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
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
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 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
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
Brain Injury, Fetus and Neonate
Diffusion-Tensor Magnetic Resonance Imaging (MRI) and the Evaluation of Perinatal Brain Injury
The researchers' objective is to use diffusion-tensor imaging (DTI) to evaluate infants diagnosed with cerebral white matter injury during the neonatal period and identify antenatal risk factors, electronic fetal heart rate…
- Trial name
- NCT00131859
- Testing
- Diffusion-tensor imaging
- Where
- 2 sites in United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
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
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
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
Hypoxic Ischemic Encephalopathy
Reno-protective Effect of Brain Cooling in Newborn With Hypoxia
This study aims to determine the effect of therapeutic hypothermia on reducing AKI in term and late-preterm infants with hypoxic ischemic encephalopathy as estimated by measurment of serum(s) neutrophil gelatinase-associated…
- Trial name
- NCT02683915
- Testing
- Therapeutic hypothermia
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Mansoura University Children Hospital
Perinatal Death, Respiratory Distress Syndrome, Newborn
Maternal Hyperoxygenation for Intrapartum Fetal Heart Rate Tracing Abnormalities
Hyperoxygenation for resuscitation of abnormal fetal heart rate tracings has been routine obstetric practice. However, there have not been any studies to support this practice.
- Conditions
- Perinatal Death, Respiratory Distress Syndrome, Newborn, Hypoxic-Ischemic Encephalopathy, Neonatal Seizure
- Trial name
- NCT03996317
- Testing
- Room air
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Loma Linda University
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
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
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
Hypoxic-Ischemic Encephalopathy, Neonatal, Brain Injuries, Hypoxic-Ischemic
Mesenchymal Stem Cells With Cooling Therapy for Infants With Hypoxic-Ischemic Encephalopathy
Hypoxic-ischemic encephalopathy (HIE) is a serious condition in newborns caused by lack of oxygen and blood flow around the time of birth.
- Trial name
- SiSTEM-NEO (NCT07018739)
- Testing
- Wharton's jelly-derived mesenchymal stem cells, 0.9 % Normal Saline
- Where
- Thailand
- Volunteers
- 40 people
- Sponsor
- Mahidol University
Hypoxic-Ischemic Encephalopathy, HIE
A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury
Infants with hypoxic-ischemic encephalopathy (HIE) are at high risk for neurodevelopmental impairment, despite current standards of care. Adjunctive treatments to promote brain repair are needed.
- Conditions
- Hypoxic-Ischemic Encephalopathy, HIE, Neurodevelopment, Infant Development
- Trial name
- NCT06429007
- Testing
- Metformin
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Boston Children's Hospital
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