Clinical trials: Hypoxia, Brain
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
High Altitude Pulmonary Hypertension
Cerebral Tissue Oxygenation in Highlanders/Lowlanders
The purpose of the current study is to evaluate the cerebral tissue oxygenation of Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by performing a longitudinal cohort study.
- Trial name
- NCT03172429
- Where
- Kyrgyzstan
- Volunteers
- 79 people
- Sponsor
- University of Zurich
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, Pain
Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
Management of neonatal pain and sedation often includes opioid therapy. A growing body of evidence suggests long-term harm associated with neonatal opioid exposure.
- Trial name
- DICE (NCT04772222)
- Testing
- Dexmedetomidine Hydrochloride, Morphine Sulfate
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of Utah
Effect of Reflexology, Hypoxic-Ischemic Encephalopathy, Neonatal
Foot Reflexology in Neonates With Hypoxic-Ischemic Encephalopathy
This randomized controlled trial aims to evaluate the effect of foot reflexology on comfort levels and physiological parameters in neonates with hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia.
- Conditions
- Effect of Reflexology, Hypoxic-Ischemic Encephalopathy, Neonatal, Foot Reflexology, Therapeutic Hypothermia
- Trial name
- NCT07549789
- Testing
- Foot reflexology, Standard care
- Where
- Turkey (Türkiye)
- Volunteers
- 84 people
- Sponsor
- Istanbul Nisantasi University
Encephalopathy, Hypoxic-Ischemic
PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment.
This study is a prospective, observational, single-center study to assess the correlation between rs-fMRI measures and clinical measures of standard MRI, NIRS, EEG and clinical scores.
- Trial name
- PEDI-REAVASC (NCT06370624)
- Testing
- MRI-scan
- Where
- Belgium
- Volunteers
- 30 people
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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
Moderate to Severe Hypoxic-ischemic Encephalopathy
Study of hCT-MSC in Newborn Infants With Moderate or Severe HIE
To determine the safety of single and repeated intravenous doses of hCT-MSC in newborn infants with HIE.
- Trial name
- NCT03635450
- Testing
- Infusion of hCT-MSC
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Joanne Kurtzberg, MD
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
Whole Body Cooling Using Phase Changing Material
A prospective randomized control trial to examine safety and effectiveness of whole body cooling to a rectal temperature of 33.5 C using phase changing material in neonatal encephalopathy.
- Trial name
- NCT01138176
- Testing
- Cooling
- Where
- India
- Volunteers
- 35 people
- Sponsor
- Robertson, Nicola, M.D.
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
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up
An extension of the CORDMILK trial, the CORDMILK follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were non-vigorous at birth and received umbilical cord milking…
- Trial name
- CORDMILK-FU (NCT03682042)
- Testing
- Umbilical Cord Milking
- Where
- 9 sites in India
- Volunteers
- 3,442 people
- Sponsor
- Nemours Children's Clinic
Hypoxic Ischemic Encephalopathy
Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (Control Levels)
Hypoxic-ischemic encephalopathy (HIE) is a serious birth complication due to systemic asphyxia which occurs in about 20 of 1,000 full-term infants and nearly 60% of premature newborns.
- Trial name
- NCT02349672
- Testing
- blood sample
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- University of Florida
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
Apgar; 0-3 at 1 Minute, Metabolic Acidosis
Autologous Stem Cells in Newborns With Oxygen Deprivation
The purpose of this study is to determine whether the plasticity of autologous intravenous application of cord blood stem cells would improve the clinical course of asphyxiated newborns.
- Conditions
- Apgar; 0-3 at 1 Minute, Metabolic Acidosis, Hypoxia, Brain, Multiple Organ Failure
- Trial name
- NCT01506258
- Testing
- Application of Stem Cells, Observation
- Where
- Mexico
- Volunteers
- 20 people
- Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
Hypoxic-Ischemic Encephalopathy
RIC in HIE: A Safety and Feasibility Trial
Remote Ischemic Conditioning has never been studied in neonates with HIE. However, RIC has been studied in animal models of perinatal asphyxia and has shown encouraging results.
- Trial name
- NCT05379218
- Testing
- Remote Ischemic Conditioning
- Where
- Canada
- Volunteers
- 32 people
- Sponsor
- The Hospital for Sick Children
Acquired Brain Injury
Effect of Methylphenidate on Ecologic Function in Paediatric Acquired Brain Injury Population
The purpose of this study is to investigate the influence of Methylphenidate in pediatric acquired brain injury population, regarding ecologic (every day) function.
- Trial name
- NCT02227056
- Testing
- Methylphenidate
- Where
- Israel
- Volunteers
- 34 people
- Sponsor
- Loewenstein Hospital
Hypoxic-Ischemic Encephalopathy
Dose Optimization of Caffeine for HIE
This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.
- Trial name
- NCT06448780
- Testing
- Caffeine citrate 20 mg/kg, Caffeine citrate 30 mg/kg
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- University of North Carolina, Chapel Hill
HIE, TBI (Traumatic Brain Injury)
Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)
This is an observational study in patients who require clinical anesthesia. The main purpose of this study is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by different…
- Conditions
- HIE, TBI (Traumatic Brain Injury), TBI, Hemodynamic Instability
- Trial name
- ICHOR 1 (NCT06195345)
- Testing
- MR Imaging
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Los Angeles
Oxygen Deficiency
Cerebral Regional Oxygenation with Manual Versus AutoFlow Ventilation
Anesthesia induction is associated with hemodynamic imbalances that can affect the blood flow to major organs. Moreover it can result in deoxygenation as well.
- Trial name
- NCT05834608
- Testing
- Mechanical ventilator-assisted ventilation
- Where
- Turkey (Türkiye)
- Volunteers
- 51 people
- Sponsor
- Marmara University