Birth Defect News

CoolCap studied at VCH may prevent brain damage after difficult birth

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.

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	Did You Know?
	Birth Defects Can Happen At Different Times During Pregnancy Birth defects happen before a baby is born. Inherited or genetic factors; things in the environment, such as smoking or drinking alcohol or not getting enough folic acid; and a woman’s illness during pregnancy can cause birth defects. Most birth defects happen in the first 3 months of pregnancy, when the organs of the baby are forming. This is the most important stage of development. However, some birth defects happen later in pregnancy. During the last six months of pregnancy, the tissues and organs continue to grow and develop.