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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00005772 |
Acute birth asphyxia is a cause of death and neurological injury. At present, there is no proven treatment; however, studies in animals suggest that brain cooling may protect against brain injury. This large multicenter trial will randomize term infants with a history of problems at delivery and signs of depression to total body cooling or standard care. Eligible infants greater than 36 wks gestation identified less than 6 hours after birth will be randomized and treated for 72 hrs to determine if cooling reduces the risk of death or moderate to severe neurologic disability at 18-22 mos.
Condition | Intervention | Phase |
---|---|---|
Hypoxic-Ischemic Encephalopathy Asphyxia Neonatorum Brain Ischemia Hypoxia, Brain |
Procedure: Induced hypothermia |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Randomized Controlled Trial of Hypothermia for Hypoxic-Ischemic Encephalopathy in Term Infants |
Estimated Enrollment: | 200 |
Study Start Date: | October 1999 |
Estimated Study Completion Date: | May 2010 |
Perinatal cerebral hypoxia-ischemia injury is an important cause of death and neurodevelopmental disability. Data from animal models suggest that brain cooling immediately after injury is neuroprotective. Experience with total body cooling during surgery, accidental near drownings, and one Phase I trial of term infants suggest that it is effective and safe in children. This large multicenter trial will test whether cerebral cooling initiated within 6 hrs of birth and continued for 72 hrs will reduce the risk of death and moderate to severe neurodevelopmental injury at 18-22 mos. Infants at least 36 weeks gestation with an abnormal blood gas within 1 hr of birth event or a history of an acute perinatal event and a 10-min Apgar score less than 5 or continued need for ventilation will be identified. Those with moderate to severe encephalopathy will be randomized to a 72 hr period of total body cooling (cooling blanket, followed by slow rewarming). The study will be conducted in two phases: Phase I (20 infants) will examine safety of an esophageal temperature of 34-35 C, Phase II (main trial, 200 infants) will evaluate the safety and efficacy of an esophageal temperature of 33-34 C. The primary outcome is death or moderate/severe disability at 18-22 mos of age; secondary outcomes include length of hospital stay, frequency of multi-organ dysfunction; withdrawal of support; post-neonatal deaths; multiple disability; seizure disorders; rehospitalization.
The sample size was based on a 50 percent incidence of death or disability (defined as cerebral palsy, Bayley MDI less than 70, deafness or blindness) following moderate to severe encephalopathy in the control group; a 30 percent reduction in the cooled group; 80 percent power; a two-tailed Type 1 error of 0.05; and 10 percent loss to follow up.
Cardio-respiratory, EEG, renal,metabolic and hematologic status and esophageal and abdominal skin temperature will be monitored during 72 hours of intervention.
Neurodevelopmental outcome will be assessed at 18-22 mos of age by masked certified examiners.
The outcome at 18-22 months has shown that whole body cooling reduces the risk of death or moderate to severe disability in infants with hypoxic ischemic encephalopathy.
Follow up will be assessed at 6-7 years in the surviving cohort of infants.
Ages Eligible for Study: | up to 6 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Stanford University | |
Palo Alto, California, United States, 94304 | |
United States, Connecticut | |
Yale University | |
New Haven, Connecticut, United States, 06520 | |
United States, Florida | |
University of Miami | |
Miami, Florida, United States, 33101 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30335 | |
United States, Indiana | |
Indiana University | |
Indianapolis, Indiana, United States, 46202-4716 | |
United States, New Mexico | |
University of New Mexico | |
Albuquerque, New Mexico, United States, 87131 | |
United States, Ohio | |
Case Western Reserve Univ | |
Cleveland, Ohio, United States, 44106 | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45267-0541 | |
United States, Rhode Island | |
Women and Infants Hospital | |
Providence, Rhode Island, United States, 02903 | |
United States, Tennessee | |
University of Tennessee | |
Memphis, Tennessee, United States, 38163 | |
United States, Texas | |
University of Texas | |
Dallas, Texas, United States, 75235 | |
University of Texas | |
Houston, Texas, United States |
Principal Investigator: | Seetha Shankaran, MD | Wayne State University |
Study ID Numbers: | NICHD-1003, U10 HD21385, U10 HD34216, U10 HD21397, U10 HD27853, U10 HD27871, U10 HD21415, U10 HD27904, U10 HD27881, U10 HD27851, U10 HD27880, U10 HD21373, U10 HD27856, U01 HD36790, M01 RR08084, M01 RR06022, M01 RR00750, M01 RR00997, M01 RR00070 |
Study First Received: | June 1, 2000 |
Last Updated: | April 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00005772 |
Health Authority: | United States: Federal Government |
Hypothermia, induced Hypoxia ischemia, brain Encephalopathy, hypoxic-ischemic Hypoxic-ischemic brain injury Asphyxia |
Infant, newborn Randomized controlled trial Seizures Encephalopathy |
Asphyxia Neonatorum Liver Diseases Death Neurotoxicity Syndromes Brain Damage, Chronic Hypoxia, Brain Disorders of Environmental Origin Brain Diseases Cerebrovascular Disorders Signs and Symptoms Hypoxia-Ischemia, Brain Mental Disorders Signs and Symptoms, Respiratory Brain Ischemia Infant, Newborn, Diseases |
Asphyxia neonatorum Dementia Brain Injuries Neurobehavioral Manifestations Hepatic Insufficiency Delirium Liver Failure Hypothermia Metabolic Diseases Neurotoxicity syndromes Seizures Poisoning Wounds and Injuries Vascular Diseases Central Nervous System Diseases |
Pathologic Processes Nervous System Diseases Central Nervous System Viral Diseases Cardiovascular Diseases |