Indiana Birth Asphyxia Study

Clinical Trials Government, Mar 29, 2007

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.

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).

United States, Indiana
Indiana University, Indianapolis,  Indiana, 

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