FDA Gives Go Ahead To Cool-Caps For HIE Babies

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Main Category: Medical Devices / Diagnostics
Also Included In: Pediatrics / Children's Health;  Neurology / Neuroscience
Article Date: 21 Dec 2006 - 10:00 PDT


A new cap that cools the heads of babies born with moderate to severe hypoxic-ischemic encephalopathy (HIE) was approved by the Food and Drug Administration (FDA) earlier today.

The cool-cap is the "first of a kind" - it keeps the head of HIE sufferers cool while their body is kept at a slightly lower temperature than normal. It is made by Olympic Medical Corporation of Seattle, WA, and is sometimes known as the "Olympic Cool-Cap" (nothing to do with Olympic athletes' swimming caps).

Dr. Daniel Schultz, director of Center for Devices and Radiological Health at the FDA said 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". He adds that until now no effective treatment for these infants other than "supportive care has existed. Up to 20 percent of them died, and 25 percent suffered permanent disability because of neurological deficits."

The manufacturer, as a condition of this approval, will be setting up a registry of all patients using the cap, and gathering information on its use and effectiveness. They will also be organizing operator training and must only allow patients who meet eligibility criteria, as defined in the original study that proved its effectiveness, to use it.

The cap keeps the infant's head cool through a steady flow of water that is kept at a controlled temperature. It was tested for safety in a study of 234 babies with moderate to severe HIE, where use of the cool-cap resulted in significantly fewer deaths and disability cases compared to non-use.

Hypoxic-ischemic encephalopathy (HIE) is 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. The topic of exactly which disabilities it causes is much debated in medical circles, but cerebral palsy and epilepsy have been mentioned.

Click here for extensive clinical information on HIE (eMedicine).

Written by: Catharine Paddock
Writer: Medical News Today
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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