Clinical trials: Hypoxic-ischemic Encephalopathy (HIE)
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
Hypoxic Ischemic Encephalopathy (HIE)
Caffeine for Hypoxic Ischemic Encephalopathy
CHIME is a randomized, parallel-arm, double-blind, placebo-controlled trial focused on infants with hypoxic ischemic encephalopathy (HIE).
- Trial name
- CHIME (NCT06855108)
- Testing
- Caffeine citrate oral solution
- Where
- 7 sites in Bangladesh, Democratic Republic of the Congo and 4 more
- Volunteers
- 830 people
- Sponsor
- NICHD Global Network for Women's and Children's Health
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
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
Hypoxic Ischaemic Encephalopathy (HIE), Premature Birth
Healing Tiny Minds: Rural Recovery Through Virtual and Lived Experience Care
The goal of this behavioral-interventional study is to learn if the Abecedarian Approach implemented virtually for children ages 0-5 with a history of Hypoxic Ischaemic Encephalopathy (HIE) and/or premature birth produces the…
- Conditions
- Hypoxic Ischaemic Encephalopathy (HIE), Premature Birth, Cerebral Palsy, Neurological Disorder
- Trial name
- NCT06643598
- Testing
- Abecedarian Approach
- Where
- United States
- Volunteers
- 225 people
- Sponsor
- University of Wisconsin, Madison
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
HIE
Beneficial Effect of Intravenous Magnesium Sulphate in Term Neonates With Hypoxic Ischemic Encephalopathy(HIE)
Neonatal mortality rate is the highest in Pakistan. And Birth Asphyxia is one of the main reversible causes. Outcomes related to birth asphyxia can be improved, if intervention done in time with proper measures.
- Trial name
- NCT04705142
- Testing
- MgSo4
- Where
- Pakistan
- Volunteers
- 200 people
- Sponsor
- Services Institute of Medical Sciences, Pakistan
Hypoxic Ischemic Encephalopathy of Newborn
Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy
Hypoxic ischemic encephalopathy is an acute or subacute brain injury, due to asphyxia in neonates, leading to mortality and long-term morbidity.
- Trial name
- NCT06522581
- Testing
- Citicoline Sodium
- Where
- Pakistan
- Volunteers
- 200 people
- Sponsor
- Armed Forces Hospital, Pakistan
Compare Between the Serum Level of Lcarnitine in HIE Cases and TTN
Measuring Serum Level of Total L Carnitine in HIE and TTN
It is a comparative prospective and observational study conducted at Neonatal Intensive Care Unit (NICU) in Assiut University Children Hospital.
- Trial name
- HIELcarnitine (NCT04546321)
- Testing
- serum L carnitine level measuring
- Volunteers
- 47 people
- Sponsor
- Assiut University
Disorder of Consciousness, Stroke
tDCS and rTMS in Patients With Early Disorders of Consciousness
A randomized controlled study was conducted to explore the efficacy of early transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) to promote wakefulness in patients with disorder…
- Conditions
- Disorder of Consciousness, Stroke, Ischemic-hypoxic Encephalopathy
- Trial name
- NCT05820178
- Testing
- tDCS, rTMS
- Volunteers
- 120 people
- Sponsor
- Xuanwu Hospital, Beijing
Hypoxia-Ischemia, Brain
The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy
The purpose of this study is to evaluate the safety and the tolerability of CL2020 cells in hypoxic ischemic encephalopathy neonates with hypothermia therapy.
- Trial name
- SHIELD (NCT04261335)
- Testing
- CL2020 cells
- Where
- Japan
- Volunteers
- 9 people
- Sponsor
- Nagoya University