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Sponsored by: |
Olympic Medical |
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Information provided by: | Olympic Medical |
ClinicalTrials.gov Identifier: | NCT00383305 |
This is a research study of head cooling. Its goal is to determine whether cooling babies' heads can reduce or prevent brain damage that may have resulted from temporarily reduced oxygen supply to the brain. In this study, half of the babies (selected at random) will have a special cooling cap with circulating water placed on their head for 72 hours to lower the temperature of their brain. The rest of the baby's body will be maintained at a defined temperature by a standard overhead radiant heater. The study protocol includes the taking and analysis of blood samples, performance of brain wave tests, imaging of the brain by ultrasound, and other tests as clinically indicated. Neurodevelopmental outcome will also be assessed at 18 months of age.
Condition | Intervention |
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Neonatal Hypoxic-Ischemic Encephalopathy (HIE) |
Device: Cool-Cap |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Brain-Cooling for the Treatment of Perinatal Hypoxic-Ischemic Encephalopathy |
Estimated Enrollment: | 235 |
Study Start Date: | July 1999 |
Estimated Study Completion Date: | September 2003 |
The objective of this study is to determine whether head cooling with mild systemic hypothermia in term infants following perinatal asphyxia is a safe procedure that improves survival without neurodevelopmental disability. Outcome will be assessed by survival and neurological and neurodevelopmental testing at 18 months of age.
Within 6 hours of birth, infants will be randomized to either a non-cooled control group with rectal temperature kept at 37+/-0.5 degC or to head cooling with mild systemic hypothermia as follows. A cooling device capable of circulating cool water in a temperature-regulated manner through a cap fitted around the infant's scalp will cool the head. The core rectal temperature of the infant will be maintained at 34.5+/-0.5 degC by adjusting the cap water temperature. The infant's rectal, nasopharyngeal, scalp (fontanel), and skin (abdominal) temperatures will be continuously monitored. Also, metabolic, cardiovascular, pulmonary and coagulation laboratory measurements will be assessed at predefined time points. Cooling will be maintained for 72 hours, followed by four hours of rewarming, with the goal of raising the rectal temperature to normal body temperature by 0.5 degC per hour. The outcome measure of severe neurodevelopmental disability and survival rates at 18 months of age will be assessed by blinded, independent observers.
Ages Eligible for Study: | up to 6 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Infants are assessed sequentially by criteria A, B and C listed below. Infant must meet all three criteria to be eligible for trial enrollment.
Criteria A: Infants >= 36 weeks gestation admitted to the NICU with ONE of the following:
Criteria B: Moderate to severe encephalopathy consisting of altered state of consciousness (as shown by lethargy, stupor, or coma) AND at least one or more of the following:
Exclusion Criteria:
Principal Investigator: | Peter D Gluckman, M.D. | The Liggins Institute, University of Auckland; Auckland, New Zealand |
Principal Investigator: | John S. Wyatt, M.D. | University College London; London, UK |
Study Director: | Alistair J Gunn, M.D., Ph.D. | Department of Physiology, University of Auckland; Auckland, New Zealand |
Study ID Numbers: | IDE G990037, PMA P040025, HIE-0198 |
Study First Received: | September 29, 2006 |
Last Updated: | September 29, 2006 |
ClinicalTrials.gov Identifier: | NCT00383305 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; United Kingdom: Department of Health; United States: Institutional Review Board |
neonatal hypoxic ischemic encephalopathy HIE birth asphyxia |
neonatal encephalopathy Asphyxia Neonatorum hypothermia, therapeutic brain cooling selective head cooling |
Asphyxia Neonatorum 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 Metabolic Disorder |
Neurobehavioral Manifestations Hepatic Insufficiency Delirium Liver Failure Hypothermia Metabolic Diseases Poisoning Vascular Diseases Central Nervous System Diseases Confusion Ischemia Encephalitis Cognition Disorders Virus Diseases Hepatic Encephalopathy |
Liver Diseases Neurotoxicity Syndromes Hypoxia, Brain Brain Damage, Chronic Disorders of Environmental Origin Central Nervous System Viral Diseases Brain Diseases Cerebrovascular Disorders Signs and Symptoms Hypoxia-Ischemia, Brain Pathologic Processes Mental Disorders Brain Ischemia Cardiovascular Diseases Neurobehavioral Manifestations |
Hepatic Insufficiency Delirium Liver Failure Metabolic Diseases Nervous System Diseases Poisoning Vascular Diseases Central Nervous System Diseases Confusion Ischemia Encephalitis Virus Diseases Hepatic Encephalopathy Digestive System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |