Clinical trials: Neonatal Encephalopathy
Hypoxic Ischemic Encephalopathy
Darbe Administration in Newborns Undergoing Cooling for Encephalopathy
Selective head cooling or whole body hypothermia has become the standard of care for neonatal hypoxia-ischemia encephalopathy (HIE).
- Trial name
- DANCE (NCT01471015)
- Testing
- Darbepoetin alfa
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- University of Utah
Hypoxic-Ischemic Encephalopathy Mild, Neonatal Encephalopathy
TIME Study: Therapeutic Hypothermia for Infants With Mild Encephalopathy
The TIME study is a randomized, controlled trial to evaluate impact on early measures of neurodevelopment and the safety profile of therapeutic hypothermia in term neonates with Mild Hypoxic-Ischemic Encephalopathy who are < 6…
- Trial name
- TIME (NCT04176471)
- Testing
- Therapeutic Hypothermia, Normothermia
- Where
- 5 sites in United States
- Volunteers
- 68 people
- Sponsor
- Stanford University
Hypoxic-Ischemic Encephalopathy Mild
Predictive Value of aEEG and Cerebral Oxygenation on Neurological Outcomes in Newborns With Mild Hypoxic-Ischemic Encephalopathy
Newborns with mild hypoxic-ischemic encephalopathy usually do not receive cooling treatment. However, some of these newborns may develop neurological problems later in life.
- Trial name
- NCT07393620
- Where
- 3 sites in Turkey (Türkiye)
- Volunteers
- 30 people
- Sponsor
- Uludag University
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, Pain
The Effect of Maternal Scent and Knitted Octopus Application on Pain in Infants Diagnosed With Neonatal Asphyxia and Receiving Therapeutic Hypothermia Treatment
This study was designed to determine the effects of maternal scent and knitted octopus application on pain in infants born with asphyxia beyond 36 weeks' gestation and receiving Therapeutic Hypothermia (TH) treatment in the…
- Trial name
- Pain in HIE (NCT07526233)
- Testing
- scent
- Where
- Turkey (Türkiye)
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Alev Sivasli
Fetal Alcohol Spectrum Disorder
Parenting Training for Children With FASD
Prenatal alcohol exposure can lead to a myriad of adverse developmental outcomes in children, and is the leading cause of mental disability in Canada.
- Trial name
- SF-FASD (NCT02210455)
- Testing
- Strongest Families FASD intervention, Psychoeducation
- Where
- Canada
- Volunteers
- 119 people
- Sponsor
- IWK Health Centre
Tuberous Sclerosis, STXBP1 Encephalopathy With Epilepsy
Gait in Rare Diseases
The aim of this pilot study is to explore whether the knowledge and experience gained during the T-GaiD project (Treatment of Gait Disorders in Dravet Syndrome - NCT03857451) can be transferred to other populations with similar…
- Trial name
- GAGA (NCT05161494)
- Where
- Belgium
- Volunteers
- 41 people
- Sponsor
- Universiteit Antwerpen
Newborn Hypoxic Ischemic Encephalopathy
Melatonin Treatment for Newborn Infants With Moderate to Severe Hypoxic Ischemic Encephalopathy
During the birth process certain conditions can cause oxygen delivery and/or blood flow to the baby's brain to become interrupted. This can cause permanent brain damage. Brain damage occurs in two phases.
- Trial name
- NCT01904786
- Testing
- Melatonin
- Where
- United States
- Sponsor
- St. Louis University
Epileptic Encephalopathy
Cannabidiol in Children With Refractory Epileptic Encephalopathy
This study will assess the safety and tolerability of a cannabidiol-enriched Cannabis Herbal Extract in a small group of children with refractory epileptic encephalopathy.
- Trial name
- CARE-E (NCT03024827)
- Testing
- CanniMed® 1:20
- Where
- 4 sites in Canada
- Volunteers
- 20 people
- Sponsor
- University of Saskatchewan
Neonatal Seizure, Hypoxic-Ischemic Encephalopathy
Neonatal Seizure Registry - Developmental Functional EValuation
The NSR-DEV study is a longitudinal cohort study of around 280 Neonatal Seizure Registry participants that aims to evaluate childhood outcomes after acute symptomatic neonatal seizures, as well as examine risk factors for…
- Conditions
- Neonatal Seizure, Hypoxic-Ischemic Encephalopathy, Stroke, Intracranial Hemorrhages
- Trial name
- NSR-DEV (NCT04337697)
- Where
- 9 sites in United States
- Volunteers
- 188 people
- Sponsor
- University of California, San Francisco
Epilepsy, Dravet Syndrome (DS)
A Study of Soticlestat in Adults and Children With Rare Epilepsies
The main aim is to assess the long-term safety and tolerability of soticlestat when used along with other anti-seizure treatment. Participants will receive soticlestat twice a day.
- Conditions
- Epilepsy, Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS)
- Trial name
- Endymion 1 (NCT03635073)
- Testing
- Soticlestat
- Where
- 59 sites in United States, Australia and 6 more
- Volunteers
- 156 people
- Sponsor
- Takeda
Altitude Hypoxia, Neonatal Encephalopathy
Neonatal Electrical Activity at Different Altitude Levels
In this study, the objective is to compare neonatal cerebral electrical activity within 3 days after birth across different altitude areas using amplitude-integrated electroencephalography (aEEG), and establish reference value…
- Trial name
- NCT05966714
- Testing
- aEEG
- Where
- 2 sites in China
- Volunteers
- 531 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Fudan University
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
Developmental and Epileptic Encephalopathy
A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)
This (DEEp OCEAN Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DEE.
- Trial name
- NCT06719141
- Testing
- LP352
- Where
- 116 sites in United States, Australia and 15 more
- Volunteers
- 367 people
- Sponsor
- Longboard Pharmaceuticals
Cerebral Palsy, Hypoxic-Ischemic Encephalopathy
Therapeutic Intervention Supporting Development From NICU to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy
The purpose of this study is to evaluate the feasibility and begin to evaluate the effect of a sensorimotor intervention (SMI) provided in the first 6 months of life for infants with hypoxic-ischemic encephalopathy.
- Trial name
- NCT05130528
- Testing
- Sensorimotor Intervention
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- University of Southern California
Asphyxia Neonatorum
Does Placenta Pathology Predict Outcome of Neonates With Hypoxic Ischemic Encephalopathy?"
The histology of the placenta of newborn infants with perinatal asphyxia and hypoxic-ischaemic encephalopathy is analysed. There will be an evaluation if placenta could be a biomarker for neurodevelopmental outcome at 18-24…
- Trial name
- NCT03284528
- Testing
- hypothermia therapy
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- University Children's Hospital, Zurich
Neonatal Encephalopathy, Epilepsy
Prevention of Epilepsy by Reducing Neonatal Encephalopathy
The aim of the study is to examine if a pragmatic, evidenced based and generalisable intrapartum care bundle involving birth companions and empowering mothers will reduce birth injury-related epilepsy at 18 months of age in…
- Conditions
- Neonatal Encephalopathy, Epilepsy, Newborn Morbidity
- Trial name
- PREVENT (NCT04054453)
- Testing
- Intra-partum care bundle invoking 4 elements
- Where
- 4 sites in India, United Kingdom
- Volunteers
- 2,000 people
- Sponsor
- Thayyil, Sudhin
Music Therapy, Pain
Music Therapy During Hypothermia in the NICU
Background: Hypoxic-ischemic encephalopathy (HIE) is a neurological condition caused by poor oxygenation during the peripartum period.
- Conditions
- Music Therapy, Pain, Allodynia, Neonates
- Trial name
- NCT06951269
- Testing
- Live entrained music therapy
- Where
- Colombia
- Volunteers
- 22 people
- Sponsor
- Fundación Santa Fe de Bogota
Hypoxic Ischemic Encephalopathy of Newborn
Chest Physical Therapy on Arterial Blood Gases for Neonates Post Hypoxic Ischemic Encephalopathy
Hypoxic-ischemic encephalopathy (HIE) is a dangerous illness that happens when a newborn's brain does not receive adequate oxygen and blood flow, which can result in serious effects such as cerebral palsy and epilepsy.
- Trial name
- NCT06950723
- Testing
- Chest Physical Therapy (CPT) modalities , Medical Treatment
- Volunteers
- 50 people
- Sponsor
- Cairo University
Encephalopathy, Developmental Delay and Behavioral Changes
RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies
RCT for Intermittent versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies
- Conditions
- Encephalopathy, Developmental Delay and Behavioral Changes, Cord Tumor Compression or Instability, Cord Tethering or Malformation
- Trial name
- NCT00515359
- Testing
- Intermittent Propofol Sedation, Continuous Propofol Sedation
- Where
- United States
- Volunteers
- 276 people
- Sponsor
- Corewell Health West