ANN ARBOR, MI - An international study has shown that a head-cooling device can reduce brain damage in oxygen-deprived newborn babies. The University of Michigan Health System’s C.S. Mott Children’s Hospital was one of 28 institutions that participated.

The results of the CoolCap trial – performed between 1999 and 2003 in the United States, New Zealand, Canada and the United Kingdom – were presented last week to the international pediatric and neonatal community at the Society for Pediatric Research’s annual meeting in San Francisco. The findings are now being submitted for publication in a major medical journal and by the device manufacturer for review by the U.S. Food and Drug Administration.

This study showed that a head-cooling treatment developed in New Zealand and the United Kingdom reduces brain damage in newborn babies that experienced an episode of interruption of blood flow and oxygen supply before delivery. The interruption can occur from complications during labor or delivery.

The CoolCap trial results, the culmination of more than 20 years of basic and clinical research, provide the first evidence in humans that brain damage at birth can be reversed at least for some babies. While more research is needed, the findings offer hope that this important problem that affects many thousands of babies around the world might be treatable.

“About one to two in 1,000 newborn babies born at or near their due date are at risk of brain damage due to interruption of blood flow or oxygen supply during the process of labor or delivery. Those who survive can be left with long-lasting disabling complications such as cerebral palsy. Previously, we had no therapy to offer to reverse this damage once it had occurred,” says John Barks, M.D., a principal investigator of the study at UMHS and associate professor of Pediatrics and Communicable Diseases at U-M Medical School.

Clinical examination combined with brain wave analysis shortly after birth enabled the researchers to identify those babies who had the best chance of responding to treatment. Babies were assigned at random to receive either the CoolCap treatment or standard newborn intensive care measures. Babies in the cooling group were fitted with the CoolCap for 72 hours.

When the infants were 18 months old, they underwent a neurological assessment by a developmental pediatrician and testing by a developmental psychologist to evaluate for both motor and mental developmental problems, as well as vision and hearing tests. The researchers found babies treated with the CoolCap saw a significant reduction in death rate and disability.

There was no evidence of serious complications or hazards from the treatment. In the most severely affected babies, treatment with the CoolCap showed no benefit.

The trial was led by Professor Peter Gluckman of the Liggins Institute at the University of Auckland in New Zealand, Professor John Wyatt of University College Hospital in London and an international team of senior scientists. There was an independent safety monitoring committee and the analysis of results was conducted independent of the company, Olympic Medical Corp. of Seattle, who made the device. The international trial was funded by Olympic Medical, which is seeking FDA approval to market the device.

Twelve families referred from hospitals in Michigan and Ohio participated in the trial at Mott’s Holden Neonatal Intensive Care Unit, and Barks says their cooperation played an important part in the research.

The CoolCap treatment is now being offered to all eligible infants at Mott’s Holden Neonatal Intensive Care Unit. Since December 2003, six additional infants have received this therapy at Mott, which has FDA permission to offer CoolCap therapy to all eligible patients as a continuation of the initial research trial.

In addition to UMHS, the hospitals involved in the study were Arkansas Children’s Hospital; National Women’s Hospital in New Zealand; Children’s Memorial Hospital/Prentice Women’s Hospital; University of Illinois at Chicago Medical Center; Children’s Hospital of New York – Presbyterian; Children’s Hospital of Denver; Duke University Medical Center; Royal Alexandra Hospital/University of Alberta Hospital; Hammersmith Hospital in the United Kingdom; Johns Hopkins University; Children’s Hospital and Clinics of Minneapolis; Children’s Hospital and Research Center at Oakland; Children’s Hospital of Oklahoma; Children’s Hospital of Eastern Ontario/The Ottawa Hospital; AI Dupont Children’s Hospital at Thomas Jefferson University Medical Center; Magee Women's Hospital/Children’s Hospital of Pittsburgh; Golisano Children’s Hospital at Strong, University of California San Diego Medical Center; University of California San Francisco Children’s Hospital; Schneider Children’s Hospital; Southmead Hospital and St. Michael’s Hospital in Bristol, England; University College Hospital in London; Vanderbilt Children’s Hospital; and Wake Forest University Baptist Medical Center.

Contact: Nicole Fawcett

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