Children's Hospital Boston Minimizing Neurological Damage from Infant At-Birth Trauma with Moderate Whole-Body Cooling

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Cincinnati Sub-Zero therapeutic hypothermia products in use in protocol implantation of neonatal hypoxic-ischemic encephalopathy treatment

Of the 13 neonates with HIE that we have treated with therapeutic hypothermia, the 12 surviving patients achieved neurological outcomes that are better than expected thus far. We will need to follow these children for several years to fully assess the results of this promising therapy.

Cincinnati Sub-Zero (CSZ) Medical, a division of CSZ Products, Inc. and the leader in the design and development of advanced patient temperature management solutions, today announced its inclusion in the implementation of a neonatal therapeutic hypothermia protocol by Children's Hospital Boston. The hospital was the first to offer the treatment in New England.

Approximately one in every 1,000 babies suffers from hypoxic-ischemic encephalopathy (HIE), a loss of oxygen at birth. Clinical studies indicate therapeutic hypothermia, including whole-body cooling begun within six hours after birth, reduces brain injury associated with the hypoxic- ischemic exposure, minimizing or avoiding consequences that might otherwise include cerebral palsy or severe cognitive and visual impairments. Depending on the severity of hypoxia-ischemia, up to 50% of babies may sustain neurological damage or death without the therapy.

Following nationwide trials involving 500 infants, the American Academy of Pediatrics (AAP) concluded in 2005 that not using therapeutic hypothermia for treating HIE resulted in greater neurological damage. Physicians at Children's Hospital Boston instituted a protocol beginning in July 2007. Using the CSZ Blanketrol® II Hypo-Hyperthermia System with CSZ cooling/warming blankets, physicians cool an infant's body to 33.5C (92.3F) for 72 hours before rewarming to normal temperature.

Children's Hospital Boston Neonatal Intensive Care Unit (NICU) Medical Director and Harvard Medical School Assistant Professor of Pediatrics Anne Hansen, MD, MPH, helped establish the treatment protocol. Says Dr. Hansen, "We have been offering therapeutic hypothermia to treat HIE for the past year with encouraging results. We hope our experience will help lead the way in therapy implementation and effectiveness."

Dr. Hansen's colleague in developing the protocol, Neonatal Neurology Program Associate Director and Harvard Medical School Assistant Professor of Neurology Janet Soul, MD, CM, said, "Of the 13 neonates with HIE that we have treated with therapeutic hypothermia, the 12 surviving patients achieved neurological outcomes that are better than expected thus far. We will need to follow these children for several years to fully assess the results of this promising therapy."

A news story about neonatal therapeutic hypothermia at Children's Hospital Boston aired yesterday, July 24, 2008, on Boston ABC affiliate, WCVB-TV, Channel 5. The media story aims to inform the medical community and general public about the benefits of the treatment.

CSZ Vice President and CSZ Medical General Manager Mark Beran said, "Hypoxic-ischemic encephalopathy is a life-altering, potentially life-threatening, event for a newborn infant. We understand the vital contribution our products can make in the lives of these babies and their families. Just knowing there is one more positive outcome as a result of applying a cooling solution, whether it's ours or not, is what matters."

Key insight around neonatal therapeutic hypothermia will disseminate in the months ahead. Educational tracks will occur at the October 2008 Therapeutic Temperature Management (TTM) Congress and the APA National Meeting. And, a nearly 400-patient study in the United Kingdom, the 'TOBY' study, will present results in November 2008.

More information about the Children's Hospital Boston therapeutic hypothermia protocol can be found at A replay of the WCVB-TV news story is available at More about the TTM Congress and the APA meeting are at and More about the TOBY study is at

About Cincinnati Sub-Zero and CSZ Medical

Cincinnati Sub-Zero (CSZ) is a leading manufacturer of temperature management products for medical and industrial markets. CSZ also manages a portfolio of industrial environmental simulation testing chambers, and a first-class, on-site, A2LA-accredited testing laboratory. CSZ Medical, a CSZ division, has delivered patient temperature management systems to healthcare professionals since 1963. The medical line of products, designed with both the patient and caregiver in mind, includes several all-in-one-system heat and cold therapy units as well as an array of warming and cooling blankets for body temperature regulation and hyper-hypothermia treatment. CSZ is a co-founder of the Therapeutic Temperature Management (TTM) Congress, an international best-practices consortium of medical community leaders. CSZ is headquartered in Cincinnati and operates globally. Visit,, and for more information.

Forward-Looking Statements

Except for statements of historical fact, the matters discussed herein are forward-looking, reflect numerous assumptions, and involve risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. We undertake no obligation to release publicly any changes in events or circumstances arising after the date hereof.


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