FDA recently approved the Olympic Cool-Cap, a new device to treat infants with hypoxic-ischemic encephalopathy(HIE), which can cause brain injury and severe neurological deficits. Up to 20 percent of infants with this condition die, and another 25 percent suffer permanent disability. Until the introduction of the new device, the only treatment has been supportive care.
The Cool-Cap is designed to reduce brain damage by selectively cooling the infant's head during the first few days of life. This is achieved by delivering a steady flow of water through a cap placed over the infant's head.
The Cool-Cap was found safe and effective in a study of 234 infants with moderate to severe HIE. At 18 months of age, there were fewer deaths and severe neurological deficits in the cooled group compared with the control group. The device should not be used in infants with major intracranial hemorrhage, an imperforate anus, or a birth weight of less than 1,800 g.
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