Clinical trials: Neonatal Encephalopathy
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
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
Familial Dementia With Neuroserpin Inclusion Bodies, Nervous System Heredodegenerative Disorder
Clinical and Genetic Studies of Familial Presenile Dementia With Neuronal Inclusion Bodies
The purpose of this study is to learn more about the medical problems and the genetic factors involved in a recently defined form of inherited dementia called "familial dementia with neuroserpin inclusion bodies (FDNIB)."…
- Trial name
- NCT00006176
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- National Human Genome Research Institute (NHGRI)
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
Congenital Heart Disease (CHD), Hypoxic Encephalopathy
Early Detection of Brain Injury After Congenital Heart Surgery in Infants
Infants with congenital heart disease undergoing cardiac surgery with extracorporeal circulation are at risk for perioperative hypoxic-ischaemic brain injury.
- Trial name
- NCT07424976
- Testing
- Observational study: blood analisys, EEG, MRI
- Where
- Slovenia
- Volunteers
- 30 people
- Sponsor
- University Medical Centre Ljubljana
Neonatal Seizures
Levetiracetam Treatment of Neonatal Seizures: Safety and Efficacy Phase II Study
LEVNEONAT is a multicentre French clinical trials with the aim to develop new treatment strategies for the treatment of neonatal seizures using Levetiracetam.
- Trial name
- LEVNEONAT-1 (NCT02229123)
- Testing
- Intravenous Levetiracetam
- Where
- 8 sites in France
- Volunteers
- 18 people
- Sponsor
- University Hospital, Tours
Premature Baby, Pulmonary Hypertension of Newborn
Measuring Heart Health in Both Term, Preterm and Unwell Newborn Babies With an Advanced Ultrasound Method: Speckle Tracking Echocardiography
This study aims to improve how neonatologists check the heart function of newborn babies, especially those who are sick. While standard heart ultrasound scans are useful, a more advanced and sensitive technique called 2D speckle…
- Conditions
- Premature Baby, Pulmonary Hypertension of Newborn, Hypoxic Ischaemic Encephalopathy (HIE), Congenital Diaphragmatic Hernia
- Trial name
- NCT07364682
- Where
- United Kingdom
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Birmingham Women's NHS Foundation Trust
Neonatal Encephalopathy, Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)
Newborn Brain Assessment - CergenX Wave
In this study we want to assess how a newly developed software device called CergenX Wave compares to the modified Sarnat examination, performed by the neonatology team .
- Conditions
- Neonatal Encephalopathy, Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy), Neonatal Encephalopathy, Unspecified
- Trial name
- NBT (NCT07857070)
- Testing
- CergenX Wave
- Where
- 2 sites in United States, Ireland
- Volunteers
- 165 people
- Sponsor
- CergenX Limited
Hypoxic Ischemic Encephalopathy, Neonatal Convulsions
Intra-operative Feed Back on Traction Force During Vacuum Extraction: Safe Vacuum Extraction Alliance
The objective of the clinical investigation is to test whether intra-operative traction force feed back during vacuum extraction leads to a significant decrease in incidence of brain damage in neonates.
- Conditions
- Hypoxic Ischemic Encephalopathy, Neonatal Convulsions, Subgaleal Hematoma
- Trial name
- SVEA (NCT03071783)
- Testing
- Vacuum extraction intelligent system
- Where
- Sweden
- Volunteers
- 800 people
- Sponsor
- Karolinska Institutet
Seizures, Seizure Disorder
A Cohort Study on the Prognosis of Neonatal KCNQ2 Gene-associated Epileptic Encephalopathy
The researchers hope to explore the etiological distribution and influencing factors of KCNQ2-related neonatal convulsions or refractory epileptic encephalopathy, and to improve the level of assessment, identification…
- Conditions
- Seizures, Seizure Disorder, Seizure Newborn, Seizures, Generalized
- Trial name
- NCT03934268
- Testing
- KCNQ2
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Children's Hospital of Fudan University
Hypoxic Ischemic Encephalopathy, Cerebral Infarction
Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy
This study examines the effect of cord blood in the treatment of newborn infants with neonatal encephalopathy in combination with hypothermia, which is the standard treatment for this condition.
- Trial name
- NCT02551003
- Testing
- Autologous cord blood, Hypothermia
- Where
- China
- Sponsor
- Children's Hospital of Fudan University
Infant, Newborn, Hypoxia, Brain
Late Hypothermia for Hypoxic-Ischemic Encephalopathy
This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ≥ 36 weeks gestational age with…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT00614744
- Testing
- Hypothermia, Normothermic Control
- Where
- 22 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
Hypoxic-Ischemic Encephalopathy, Brain Injury
Prospective Research in Infants With Mild Encephalopathy
A multicenter observational pilot study will be conducted to determine the natural history of infants with early diagnosis (≤ 6 hrs of age) of mild neonatal encephalopathy (NE) who are not qualified for therapeutic hypothermia.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Brain Injury, Neonatal Seizure
- Trial name
- PRIME (NCT01747863)
- Testing
- Neurologic examination
- Where
- 7 sites in United States, Canada and 2 more
- Volunteers
- 63 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Neonatal Seizures
NEMO1:NEonatal Seizure Using Medication Off-patent
NEMO is a multicentre pan European clinical trial with the aim to develop new treatment strategies for the treatment of neonatal seizures using the loop diuretic bumetanide.
- Trial name
- NEMO1 (NCT01434225)
- Testing
- Bumetanide
- Where
- 7 sites in Ireland, Netherlands and 2 more
- Volunteers
- 14 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
Hypoxic Ischemic Encephalopathy of Newborn
Maternal and Neonatal Risk Factors of HIE
The current work aims to: The primary aim in this study was to identify the contribution of maternal, pregnancy, birth and neonatal factors to encephalopathic features in new born infants.
- Trial name
- NCT05749458
- Volunteers
- 100 people
- Sponsor
- Assiut University
Birth Asphyxia
Asphyxia Associated Metabolite Biomarker Investigation 2
Follow-up of participants of AAMBI1 study at age of at least 2 years. AAMBI1(ClinicalTrials.gov ID: NCT03354208): Verification of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia.
- Trial name
- AAMBI2 (NCT04714502)
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 144 people
- Sponsor
- InfanDx AG
Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome)
An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM)
The goal of this clinical trial is to evaluate the long-term safety and tolerability of zagociguat in patients with MELAS who completed study medication treatment in the lead-in study TIS6463-203.
- Trial name
- NCT06961344
- Testing
- zagociguat 15mg
- Where
- 16 sites in United States, Australia and 3 more
- Volunteers
- 37 people
- Sponsor
- Tisento Therapeutics
Hyperammonemic Encephalopathy
Optimalisation of the Treatment of Acute Neonatal Hyperammonaemia
Acute neonatal hyperammonemia is associated with poor neurological outcomes and high mortality. A user-friendly and widely applicable algorithm - based on kinetics - to tailor the treatment of acute neonatal hyperammonemia.
- Trial name
- NCT05754372
- Testing
- user-friendly and widely applicable algorithm to tailor the treatment of acute neonatal hyperammonemia
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- University Hospital, Ghent
Hypoxic- Ischemic Encephalopathy, Whole-Body Hypothermia
Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy(HIE)
Among term infants, hypoxic-ischemic encephalopathy due to acute perinatal asphyxia remains an important cause of brain injury in childhood.
- Conditions
- Hypoxic- Ischemic Encephalopathy, Whole-Body Hypothermia, Brain Injury
- Trial name
- NCT05581927
- Testing
- modified Whole-Body Hypothermia, standard Whole-Body Hypothermia
- Where
- China
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Neonatal Encephalopathy, Therapeutic Hypothermia
The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era
The goal of this study is to characterize the ability and related brain profiles of children with Neonatal encephalopathy (NE) - Therapeutic hypothermia (TH) at 9 years old. The main questions it aims to answer are: 1.
- Conditions
- Neonatal Encephalopathy, Therapeutic Hypothermia, Brain Injuries, Child Development
- Trial name
- NCT05756296
- Testing
- Therapeutic hypothermia
- Where
- 2 sites in Canada
- Volunteers
- 198 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre