CoolCap studied at VCH may prevent brain damage after difficult birth

(Nashville, Tenn.)- A cap designed to cool the brains of babies born
with oxygen deprivation during birth may prevent brain damage.
Vanderbilt Children’s Hospital researchers participated in the study of
the device, "CoolCap," to cool the brains of full-term babies who were
oxygen-deprived and had signs of brain damage within hours of birth.

While the cap offered a moderate overall reduction in brain damage, by
about 10 percent, the most promising results were among babies who
suffered moderate damage at birth. The effects of motor damage, such as
cerebral palsy, were reduced by almost 60 percent.

William F. Walsh, MD, director of nurseries at VCH’s Neonatal Intensive
Care Unit (NICU) said it was exciting to be part of the trial.

"The animal data was pretty compelling," Walsh said, "and we’ve been
watching the animal studies for years. These babies are particularly
heartbreaking. They’re big and full-term, but there is nothing that can
be done for this type of birth injury and it’s hard to stand there and
do nothing."

Over the course of the three-year study, from 1999 to 2002, Vanderbilt
Children’s Hospital received newborns referred from all of Middle
Tennessee. The babies had to be full-term and enrolled within five
hours of birth. Because of the stringent requirements, only 13 babies
were enrolled. Six babies were monitored and treated with standard
therapies as the control group. Seven babies were placed in a CoolCap
for a critical 72 hours.

"There seemed to be a short period of time after birth before they
began to get worse," Walsh said. "The concept of using this window of
opportunity to prevent a cascade of apoptosis or "cell suicide" by
cooling was simple, there was good animal data and there was no
alternative at the time the study began."

Babies were referred following a variety of birth difficulties,
including ruptured uterus, placental abruption and cord compression.
Brain wave analysis was used at birth to determine the degree of
initial brain injury.

While the CoolCap did not appear to cause any complications for the
babies, those who had suffered the most devastating brain injuries at
the start showed no benefit from CoolCap.

"But what was exciting was that at the 18-month follow up, those babies
who were determined to have moderate brain damage at birth showed a
significant reduction in signs of cerebral palsy." Walsh said.

The study results show that if you exclude the most severely
brain-damaged babies; the number of moderately brain-injured infants
who died was reduced from 39 percent to 25 percent. Of infants in the
control group, 27.8 percent had signs of a severe neuromotor disability
like cerebral palsy, compared with 11 percent of CoolCap babies. That
represents a 58 percent reduction in motor abnormalities.

The international CoolCap trial had 28 centers participating from the United States, United Kingdom, Canada and New Zealand.

The results of the CoolCap trial were presented last week at the annual
meeting of the Society for Pediatric Research in San Francisco.
The findings are now being submitted for publication in a peer-reviewed
journal, and by the manufacturer for review by the Food and Drug
Administration. Olympic Medical, manufacturer of the CoolCap, sponsored
the trial.

Contact: Carole Bartoo, 322-4747