Cool-Caps Controls Babies' Temperature

A new throwaway cap cools the heads of babies born with moderate to severe hypoxic-ischemic encephalopathy (HIE).

The Cool-cap system keeps the infant's head cool by means of a steady stream of water at a controlled temperature flowing through the cap. To control core temperature, the clinician adjusts the cap temperature while the infant is under a radiant warmer, so that while the head of HIE sufferers is kept cool during a 72-hour cooling period, their body is kept at a temperature that is slightly lower than normal. The system monitors all critical temperature parameters, displays a continuous tracing of core temperature over the entire period, computes rate of change, and provides sensitive temperature adjustment. A software program guides the staff through the cooling protocol from start to finish, and includes an initial setup wizard, prompts, alarms, and a help window. A solid-state water cooler is used for precise temperature control, and the disposable cooling caps are provided in three sizes.

The Cool-cap is a product of Olympic Medical (Seattle, WA, USA), and has been approved by the U.S. Food and Drug Administration (FDA).

"This announcement will bring new hope to parents of the approximately 5,000-9,000 babies each year who are born in the United States with moderate to severe hypoxic-ischemic encephalopathy,” said Dr. Daniel Schultz, director of the Center for Devices and Radiological Health at the FDA. "Until now no effective treatment for these infants other than supportive care has existed. Up to 20% of them died, and 25% suffered permanent disability because of neurological deficits.”

HIE occurs when the cells in the brain and spinal cord are damaged because of oxygen starvation (asphyxia). Moderate to severe HIE is a potentially fatal injury that can lead to various forms of disability in survivors, including cerebral palsy and epilepsy.



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