Clinical trials: Neonatal Encephalopathy, active
Mucopolysaccharidosis Disorders, Hurler Syndrome
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
This single-institution, phase II study is designed to test the ability to achieve donor hematopoietic engraftment while maintaining low rates of transplant-related mortality (TRM) using busulfan- and fludarabine-based…
- Conditions
- Mucopolysaccharidosis Disorders, Hurler Syndrome, Hunter Syndrome, Maroteaux Lamy Syndrome
- Trial name
- NCT02171104
- Testing
- Stem Cell Transplantation, IMD Preparative Regimen, Osteopetrosis Only Preparative Regimen
- Where
- United States
- Volunteers
- 149 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
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
Neonatal Seizure, Neonatal Encephalopathy
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
The main purpose of this study is to determine the maximum safe tolerated dose of LEV in the treatment of neonatal seizures. Our hypothesis is that optimal dosing of Levetiracetam (LEV) to treat neonatal seizures is significantly…
- Conditions
- Neonatal Seizure, Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Seizure Newborn
- Trial name
- NEOLEV3 (NCT05610085)
- Testing
- Levetiracetam Injection, Phenobarbital Sodium Injection
- Where
- 6 sites in United States, New Zealand
- Volunteers
- 133 people
- Sponsor
- University of California, San Diego
Therapeutic Hypothermia, Neonatal Hypoxic-Ischemic Encephalopathy
Continuous Monitoring of Body Temperature in Neonates During Therapeutic Hypothermia
This prospective observational pilot study aims to evaluate the feasibility, accuracy, and safety of the SteadyTemp® wireless adhesive thermometer for continuous, non-invasive body temperature monitoring in neonates undergoing…
- Conditions
- Therapeutic Hypothermia, Neonatal Hypoxic-Ischemic Encephalopathy, Neonatal Thermal Management
- Trial name
- MonT HT (NCT07756892)
- Testing
- continous temperature measurement
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Medical University of Graz
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
Neonatal Encephalopathy
Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia
Around the time of birth, some babies experience a condition called asphyxia, which means that their brain and other organs do not receive enough blood and/or oxygen to work properly.
- Trial name
- NCT06098833
- Testing
- Sildenafil, Ora-Blend
- Where
- 3 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Pia Wintermark
Chikungunya Virus Infection, Neonatal
Against Chikungunya Virus and Neonatal Infection
The goal of this clinical trial is to learn if administration of plasma, from a whole blood donation from an individual who has declared a Chikungunya infection for less than 6 months , to a newborn, whose mother has a peripartum…
- Conditions
- Chikungunya Virus Infection, Neonatal, Transfusion, Encephalopathy
- Trial name
- ConvictionCHIK (NCT07190560)
- Testing
- plasma transfusion : PC-CHIK-V
- Where
- 3 sites in France, French Guiana and 1 more
- Volunteers
- 60 people
- Sponsor
- Centre Hospitalier Universitaire de la Réunion
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, Perinatal Asphyxia
EEG-Based Decision-Support Algorithm for Hypoxic-Ischemic Encephalopathy in Term Newborns
This retrospective, multicenter, observational study evaluates how well a decision-support algorithm can tell apart mild forms of hypoxic-ischemic encephalopathy (HIE) from moderate or severe forms in full-term newborns born…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia, Neonatal Brain Injury
- Trial name
- COOLDECIDE (NCT07764315)
- Volunteers
- 310 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy
Neonatal Neurological Observation With Video AI
NeoNOVA is a multi-site, prospective, single-arm, silent observational study to determine: among (Population) infants admitted to newborn services during their inpatient hospital stay, whether (Intervention) continuous bedside…
- Conditions
- Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Sedation, Sleep
- Trial name
- NeoNOVA (NCT07628829)
- Testing
- Continuous bedside video monitoring with AI anatomic landmark tracking for neurologic monitoring
- Where
- 2 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Artemis AI Labs
Spinal Muscular Atrophy, Fragile X Syndrome
Early Check: Expanded Screening in Newborns
Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and…
- Conditions
- Spinal Muscular Atrophy, Fragile X Syndrome, Fragile X - Premutation, Duchenne Muscular Dystrophy
- Trial name
- NCT03655223
- Testing
- Confirmatory Testing
- Where
- United States
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- RTI International
Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy
Healthy Little Eyes
The purpose of this research study is to gather more information on how eye injury is related to a baby's future development and see if eye function and brain test results can be used, along with current measures, to better…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy, Encephalopathy
- Trial name
- NCT05971446
- Testing
- Visual Evoked Potential (VEP), Electroretinogram (ERG)
- Where
- United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Anoxia-Ischemia, Brain, Neonatal Encephalopathy
Neonate Cerebral Activity in Immediate Post Partum
Neonatal anoxia-ischemia causes significant neurodevelopmental disorders. In this study the investigators want to better understand the interactions between the nervous and the hemodynamic cerebral systems during the adaptation…
- Trial name
- POSTPARTUM (NCT04225975)
- Testing
- electroencephalogram, oxymetry
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Hypoxic-Ischemic Encephalopathy, Asphyxia
Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates
This is a prospective, single center, pharmacokinetic study of intravenous hydrocortisone therapy for systemic low blood pressure during hypothermia treatment in asphyxiated newborns.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Asphyxia, Hypotension, Circulatory Failure Neonatal
- Trial name
- UniCort (NCT05836610)
- Testing
- Hydrocortisone
- Where
- Hungary
- Volunteers
- 50 people
- Sponsor
- Semmelweis University
Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy
Investigating Cerebral Oxygenation in the Newborn
The goal of this single centre observational study is to use near-infrared spectroscopy (NIRS) monitoring to investigate cerebral oxygenation in two groups of newborn infants who are at high risk of brain injury.
- Conditions
- Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy, Premature Infant Disease
- Trial name
- ICON (NCT05588960)
- Testing
- Near-infrared spectroscopy monitoring (Masimo O3 Regional Oximeter with Neonatal Sensor)
- Where
- United Kingdom
- Volunteers
- 99 people
- Sponsor
- University of Edinburgh
Neonatal Encephalopathy, Hypoxic Ischaemic Encephalopathy (HIE)
Genetics of Neonatal Encephalopathy and Related Disorders
Investigators at Boston Children's Hospital are conducting research in order to better understand the genetic factors which may contribute to neonatal encephalopathy (NE) and related disorders.
- Trial name
- NCT07165938
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Boston Children's Hospital
Diastolic Dysfunction, Neonatal Encephalopathy
Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography
The goal of this single-centre longitudinal observational study is to create reference values for diastolic function parameters in neonates born at 35 weeks' gestation or above, and to assess the influence of pre-defined…
- Conditions
- Diastolic Dysfunction, Neonatal Encephalopathy, Small for Gestational Age at Delivery, Transient Tachypnea of the Newborn
- Trial name
- DiFuSE (NCT06200519)
- Where
- Ireland
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- University College Cork
Neonatal Encephalopathy
Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonatal Encephalopathy
The aim of our study is to evaluate the feasibility of applying transcutaneous CO2 monitoring (tcPCO2) in neonates receiving therapeutic hypothermia and to quantify the agreement between tcPCO2 and PCO2 in this population with or…
- Trial name
- NCT04603547
- Testing
- Transcutaneous Carbon Dioxide Monitoring
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Brigham and Women's Hospital
Neonatal Encephalopathy, Newborn Asphyxia
Cooling in Mild Encephalopathy
The goal of this randomised control trial is to establish the safety and efficacy of whole-body hypothermia for babies with mild hypoxic ischaemic encephalopathy, inform national and international guidelines, and establish…
- Trial name
- COMET (NCT05889507)
- Testing
- Whole body hypothermia, Targeted normothermia, Supportive neonatal intensive care
- Where
- 39 sites in Italy, United Kingdom
- Volunteers
- 426 people
- Sponsor
- Imperial College London
Neonatal Seizure, Hypoxic-Ischemic Encephalopathy
Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy
The NSR-GENE study is a longitudinal cohort study of approximately 300 parent-child trios from the Neonatal Seizure Registry and participating site outpatient clinics that aims to evaluate whether and how genes alter the risk of…
- Conditions
- Neonatal Seizure, Hypoxic-Ischemic Encephalopathy, Stroke, Intracranial Hemorrhage
- Trial name
- NSR-GENE (NCT05361070)
- Where
- 8 sites in United States
- Volunteers
- 300 people
- Sponsor
- University of California, San Francisco