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Study 5 of 420 for search of: | received on or after 12/30/2008 |
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Sponsors and Collaborators: |
Zhengzhou University Medical University Innsbruck, Austria |
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Information provided by: | Zhengzhou University |
ClinicalTrials.gov Identifier: | NCT00817401 |
Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and mortality in term and preterm neonates. Birth asphyxia accounts for 23% of neonatal deaths globally and survivors suffer from long term neurological disability and impairment. Although many neuroprotective strategies appeared promising in animal models, most of them were not feasible and effective in human newborns. However, hypothermia was reported not to be effective if introduced beyond and thus should be introduced within 6 hrs after birth.Applying this selection criterion naturally would deprive many patients of the opportunity of hypothermia treatment.
Condition | Intervention | Phase |
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Hypoxic-Ischemic Encephalopathy |
Device: hypothermia |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effect of Systemic Hypothermia on Neonatal Hypoxic-Ischemic Encephalopathy |
Enrollment: | 100 |
Study Start Date: | July 2002 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Hypoxic-ischemic encephalopathy of the newborn infant remains a significant socio-economic health problem worldwide. Moderate to severe HIE of newborn infants is associated with a high rate of death or long-term disabilities. Historically, treatment has been purely supportive including stabilizing cardio-respiratory functions and treating convulsions. Recent multi-center trials assessing the effects of hypothermia demonstrated improved outcome in term neonates with moderate hypoxic-ischemic encephalopathy (HIE). However, hypothermia was not effective beyond 6 hrs after brain injury. The aim of this study was to investigate whether systemic hypothermia induced up to 10 hrs after birth would improve the neurodevelopmental outcome at 18 months in infants with moderate or severe HIE.
Ages Eligible for Study: | up to 10 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
with one of the following factors:
Exclusion Criteria:
China, Henan | |
NICU, the Third Affiliated Hospital, Zhengzhou University | |
Zhengzhou, Henan, China, 450052 |
Study Director: | Changlian Zhu, MD, PhD | Zhengzhou University |
Responsible Party: | Zhengzhou University ( Professor Changlian Zhu ) |
Study ID Numbers: | HN-200084001 |
Study First Received: | January 2, 2009 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00817401 |
Health Authority: | China: Ministry of Health |
asphyxia hypothermia hypoxic-ischemic encephalopathy neonates |
Liver Diseases Neurotoxicity Syndromes Hypoxia, Brain Brain Damage, Chronic Disorders of Environmental Origin Brain Diseases Cerebrovascular Disorders Signs and Symptoms Hypoxia-Ischemia, Brain Mental Disorders Brain Ischemia Brain Injuries Dementia Neurobehavioral Manifestations Hepatic Insufficiency |
Delirium Liver Failure Hypothermia Metabolic Diseases Neurotoxicity syndromes Poisoning Vascular Diseases Central Nervous System Diseases Confusion Ischemia Encephalitis Cognition Disorders Virus Diseases Hepatic Encephalopathy Digestive System Diseases |
Pathologic Processes Nervous System Diseases Central Nervous System Viral Diseases Cardiovascular Diseases Body Temperature Changes |