Clinical trials: Hypoxic-Ischemic Encephalopathy, Neonatal
Hypoxic Ischemic Encephalopathy
Magnetic Resonance Imaging and Spectroscopy Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy
Neonatal hypoxic ischemic encephalopathy (HIE) is a serious neurological condition characterised by acute or subacute brain injury arising from perinatal hypoxia.
- Trial name
- NCT01481207
- Where
- Switzerland
- Volunteers
- 59 people
- Sponsor
- University Children's Hospital, Zurich
Hypoxic Ischemic Encephalopathy, Perinatal Asphyxia
Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy
Oxygen radicals and inflammation are important causes for brain injury in neonates following perinatal asphyxia. Animal studies demonstrated potential benefits to the brain when using both of vitamin C and ibuprofen.
- Trial name
- NCT00624871
- Testing
- Ascorbic acid (vitamin C), Ibuprofen
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Al-Azhar University
Infant, Newborn, Hypoxia, Brain
Preemie Hypothermia for Neonatal Encephalopathy
This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hours postnatal age with moderate to…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT01793129
- Testing
- Hypothermia, Normothermic Control
- Where
- 18 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
Mild Hypoxic Ischemic Encephalopathy of Newborn
Cool Prime Comparative Effectiveness Study for Mild HIE
To determine effectiveness of therapy to improve neurodevelopmental outcomes in infants with mild HIE. To determine the adverse effects of Therapeutic Hypothermia (TH) in mild HIE on the neonate and his/her family.
- Trial name
- COOLPRIME (NCT04621279)
- Testing
- Normothermia, Whole body therapeutic hypothermia
- Where
- United States
- Volunteers
- 460 people
- Sponsor
- University of Texas Southwestern Medical Center
Neonatal Seizures, HIE - Hypoxic - Ischemic Encephalopathy
Treatment of Seizures in Neonate With HIE
Aim of the study To evaluate and compare phenobarbital's and levetiracetam's safety and efficacy for treating seizures in neonates with moderate to severe HIE
- Trial name
- HIE (NCT07284498)
- Testing
- Phenobarbital, Levetiracetam
- Where
- 2 sites in Egypt
- Volunteers
- 66 people
- Sponsor
- Mansoura University
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU)
An extension of the MIDAB trial, the MIDAB-Follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (UCM) or…
- Trial name
- MIDAB-FU (NCT03681314)
- Testing
- Umbilical Cord Milking
- Where
- 3 sites in India
- Sponsor
- Nemours Children's Clinic
Congenital Heart Disease in Children, Neuroprotection
Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass
Neurodevelopmental impairment due to delayed brain development and brain injury is a fundamental problem in children with critical congenital heart disease (CCHD).
- Trial name
- CRUCIAL (NCT04217421)
- Testing
- Allopurinol, Mannitol
- Where
- 4 sites in Netherlands
- Volunteers
- 236 people
- Sponsor
- dr. M.J.N.L. Benders
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 Encephalopathy, Umbilical Cord Milking
Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy
The objective of this pilot study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth.
- Trial name
- NCT02287077
- Testing
- Umbilical Cord Milking
- Where
- India
- Volunteers
- 101 people
- Sponsor
- Thomas Jefferson University
Small for Gestational Age at Delivery, Hypoxic-Ischemic Encephalopathy
Umbilical Cord Abnormalities in the Prediction of Adverse Pregnancy Outcomes
The objective of our study is to investigate the association of umbilical cord abnormalities with adverse pregnancy outcomes. The umbilical cord parameters that will be investigated as part of this study include the umbilical…
- Conditions
- Small for Gestational Age at Delivery, Hypoxic-Ischemic Encephalopathy, Stillbirth, Admission to Neonatal Unit
- Trial name
- ULOOP (NCT05901688)
- Testing
- Umbilical cord measurements & observations
- Where
- United Kingdom
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Medway NHS Foundation Trust
Hypoxic-Ischemic Encephalopathy
Neurological Outcome After Erythropoietin Treatment for Neonatal Encephalopathy
Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and mortality in term and preterm neonates, accounting for 23% of neonatal deaths globally.
- Trial name
- NCT00808704
- Testing
- recombinant human erythropoietin
- Where
- China
- Volunteers
- 167 people
- Sponsor
- Zhengzhou University
Hypoxic-Ischemic Encephalopathy
Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy
The purpose of this study is to determine whether nerve growth factor (cerebrolysin®) therapy will improve the psychomotor outcome in infants with moderate and severe hypoxic ischemic encephalopathy after hospital discharge.
- Trial name
- CerebroHIE (NCT01059461)
- Testing
- Cerebrolysin®
- Where
- 2 sites in Egypt
- Volunteers
- 40 people
- Sponsor
- Sahar M.A. Hassanein, MD
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
Neonatal Encephalopathy
Sildenafil Administration to Treat Neonatal Encephalopathy
Despite improvements in neonatal care, birth asphyxia in term newborns remains a serious condition causing significant mortality and long-term morbidity, including cerebral palsy and mental retardation.
- Trial name
- SANE-01 (NCT02812433)
- Testing
- Sildenafil, Ora-Blend
- Where
- Canada
- Volunteers
- 28 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Hypoxic Ischemic Encephalopathy of Newborn, Premature Birth
Metformin Treatment in Infants After Perinatal Brain Injury
A phase I study to test the feasibility and safety of treatment with metformin in infants affected by hypoxic ischemic encephalopathy (HIE) or prematurity-related brain injury
- Trial name
- NCT05590676
- Testing
- Metformin Hydrochloride
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- The Hospital for Sick Children
Perinatal Death, Respiratory Distress Syndrome, Newborn
Maternal Hyperoxygenation for Intrapartum Fetal Heart Rate Tracing Abnormalities
Hyperoxygenation for resuscitation of abnormal fetal heart rate tracings has been routine obstetric practice. However, there have not been any studies to support this practice.
- Conditions
- Perinatal Death, Respiratory Distress Syndrome, Newborn, Hypoxic-Ischemic Encephalopathy, Neonatal Seizure
- Trial name
- NCT03996317
- Testing
- Room air
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Loma Linda University
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
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
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
Hypoxic Ischemic Encephalopathy
Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy
The purpose of this study is to determine the efficacy of high dose Erythropoietin to improve survival and neurologic outcome in asphyxiated term newborn undergoing cooling.
- Trial name
- Neurepo (NCT01732146)
- Testing
- erythropoietin Beta
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris