May 6 2004
A major international clinical trial has shown that a head-cooling device developed by University of Auckland Liggins Institute
researchers prevents brain damage in oxygen-deprived newborn babies.
Liggins Institute Director and trial Director Professor Peter Gluckman said the CoolCap trial results were the culmination of over 20 years work and provided the first evidence in humans that brain damage at birth could be treated. The findings offered hope for a new approach to a major set of clinical conditions, he said.
The results of the CoolCap trial piloted in Auckland and then performed between 1999 and September 2003 in New Zealand, the United States, Canada and Britain were this week presented to the international paediatric and neonatal community at the annual meeting of the Society for Pediatric Research in San Francisco, USA. The findings will now be submitted for publication in a peer-reviewed journal.
A team of researchers and neonatal specialists from the Liggins Institute and National Women's Hospital, including Liggins Director Professor Peter Gluckman, paediatrician and Liggins medical researcher Dr Alistair Gunn, and his late mother Professor Tania Gunn pioneered the development of the CoolCap first in animal then human studies.
Professor Gluckman and his colleague Professor John Wyatt from University College Hospital, London led the trial.
Professor Peter Gluckman said today the international trial results should give hope for the parents of newborns who were asphyxiated at birth.
"About one to two in 1,000 newborn babies born at term are at risk of brain damage during the birth process. It is much higher in those from poorer countries and in premature infants. Those who survive can be left with heartbreaking conditions such as cerebral palsy or severe intellectual impairment."
"This randomised CoolCap study, conducted in 24 centres and involving 234 newborns, shows that treated infants had a reduced rate of death or severe disability. The key findings are:
18 months after birth, there was a statistically significant reduction in severe disabilities among those treated with the CoolCap - this was dramatic.
Brain wave analysis used at birth enabled the researchers to identify those most severely affected at birth and in this most severely affected group, it was shown that the CoolCap had no benefit - which was the anticipated result.
However, in the second group of babies, the number who died was reduced from 39% to 25%."
"Moreover, the incidence of handicap among those who survived was reduced by two thirds, or 60%."
Professor Gluckman said the research leading to the CoolCap international trial reflected the dedication and talent of people such as the late Professor Tania Gunn, Associate-Professor Alistair Gunn, and all those who have contributed to the research and international trial. It also showed that the Liggins Institute was a world leader in medical discovery and follows in the tradition of Sir William Liley and Sir Graham (Mont) Liggins in the leadership New Zealand continues to have in perinatal research and its clinical application.
Associate-Professor Alistair Gunn said the trial results showed that many babies at risk of brain damage would in the future have a chance for effective intervention.
"Brain damage from oxygen deprivation is the single most important cause of disability in childhood."
"Pilot studies on the CoolCap led by my mother Professor Tania Gunn - started in 1994. To have demonstrated in an international trial that the CoolCap can prevent the death of oxygen-deprived cells is a remarkable moment in my scientific career. It is also the ultimate tribute to the pioneering work of my mother and Professor Gluckman who started working together on issues of temperature and the neonate in 1982," said Associate- Professor Gunn.
The CoolCap trial was registered with the US Food and Drug Administration. Infants assigned to the hypothermia group were fitted with the CoolCap for 72 hours. Those in the control group received standard clinical care.
A daily neurological examination was performed on both groups until 72 hours and at discharge. At one week of age, all tests which were abnormal at 72 hours were repeated and a full neurological examination was performed.
At 18 months, infants had a neurological assessment by a paediatrician and assessment by a developmental psychologist, as well as visual and auditory assessment. Assessment staff were not told which of the two study groups the infants had been in.
The development of the CoolCap was supported by the Health Research Council, the Auckland Medical Research Foundation, Lottery Health and Olympic Medical (Seattle). The international trial was sponsored by Olympic Medical (Seattle, USA). Olympic Medical intends to market the Cool Care System internationally once it receives FDA approval.