When an infant has received inadequate supply of oxygen during labor or delivery, may cause brain injury, confirmed by less electrical activity in the brain or brain wave analysis. A lack of oxygen at birth can result from a ruptured uterus, placenta (Receives oxygen, nutrients, antibodies and hormones from the mother’s blood and pass out waste.) that peels off to early or rupture, breech birth or collapse of the umbilical cord. The umbilical cord can wrap around the infant’s neck and cut of the supply of oxygen or suffer hypoxic damage. Infants that survive can have long — lasting disabling complications, such as cerebral palsy (Child has trouble controlling the muscles of the body, and may not be able to walk, talk, eat or play.) Hearing and speech problems may require the child to receive treatment by a speech therapist. Previously, no treatment or therapy was available to reverse this damage or prevent this damage from occurring, except only to place the infant on a respirator and give medicine to support blood pressure and other functions.
Professor Peter Gluckman of the Liggins, Institute at the University of Auckland in New Zealand and Professor John Wyatt of University College Hospital in London and international team of senior scientists lead a trial investigation (1999 – 2003) of a device made by Olympic Medical Corporation of Seattle called Coolcap. The device provides a head — cooling treatment (The Cool-Cap System sends a steady flow of cool water through a cap placed on an infant’s head.), reduces brain damage in newborn babies that experienced an episode of interruption of blood flow and oxygen supply before delivery. The cooling is thought to interfere with the biochemical process that develops, when brain cells are deprived of oxygen. The study conducted in New Zealand, Canada and United Kingdom. During previous clinical research over a period of twenty years, provided evidence that brain damage at birth can be reversed at least for some babies. Researchers found babies treated with the CoolCap saw a significant reduction in death rate and disability. The cooling cap keeps the body temperature near 94 degrees, must be placed within six hours of birth and remain on for seventy-two hours. Afterwards, followed by gradual re-warming and standard care. There is a small window of opportunity (Several hours before permanent damage occurs through chemical reactions in the brain that develop.) after birth, preventing a lifetime of disability or lessen severe brain injury, as result of hypoxic damage. Successful results confirmed, when eighteen months old infants underwent a neurological assessment to evaluate for both motor and mental developmental problems, as well as vision and hearing tests. In May 2004, During the Society for Pediatric Research annual meeting in San Francisco, findings where presented (regarding Coolcap) and published in January 2006 in the British medical journal the Lancet.
Susan Adeniyl-Jones, a Thomas Jefferson University Hospital Neonatologist who has been testing CoolCap said: “If you slow down metabolism and decrease the brain’s energy needs, the brain can funnel all the efforts toward healing and repair.”
In December 2006, the Food and Drug Administration (FDA) gave approval to market Coolcap, made by Olympic Medical Corporation of Seattle (Olympic Medical was acquired by Natus Medical in October 2006), treat hypoxic ischemic encephalopathy (HIE) (Brain damage caused by a lack of oxygen and lack of blood flow to the brain) during labor and delivery. As a condition of approval by the FDA, the manufacture must set up a registry to track how patients fare after their treatment. Also, must train and certify health care workers who intend to use the device and restrict it use to patients who meet certain eligible requirements or criteria. Dr. Daniel Schultz, director of FDA’s Center for Devices and Radiological Health said: “This approval brings new hope to parents of the approximately 5,000 – 9,000 babies each year who are born in the United States with moderate to sever hypoxic – ischemic encephalopathy. Until now, there has been no effective treatment for those infants other then supportive care. Up to 20 percent of them died, and 25 percent suffered permanent disability because of neurological deficits.”