Background: The CoolCap Trial
The CoolCap international clinical trial shows it is the first effective treatment for brain damage in oxygen-deprived
newborn babies.
The treatment was pioneered in New Zealand by researchers from The University of Auckland Liggins Institute and neonatal
specialists at National Women’s Hospital in Auckland. Members of the original team include the late Professor Tania
Gunn, her son Associate Professor Alistair Gunn and Liggins Institute Director Professor Peter Gluckman. It arose from
earlier work started by Professor Gluckman and Professor Tania Gunn in 1982.
The time immediately before and after birth – called the perinatal period – is critical to a child’s development. About
one or two in 1,000 newborn babies are at risk of brain damage during birth, despite what are often normal, healthy
pregnancies. The result, if these babies survive, can be permanent intellectual disabilities or cerebral palsy.
The Cool Care System™ is a device that can be fitted onto the head of babies who are starved of oxygen at birth. The
system is designed to remain in contact with the scalp in all areas during the treatment; it does not cover the forehead
or ears. It consists of a small thermostatically controlled cooling unit and a pump that circulates water through the
Cool Care System™.
Liggins Institute researchers have shown that many brain-injured babies appear to recover in the first few hours after
birth, but the cells that initially survive remain at risk of swelling up and dying many hours afterwards. This
phenomenon is called apoptosis, or “cell suicide”.
The Cool Care System™’s function is to lower the temperature of the baby’s brain during this critical 72- hour period,
thereby protecting against apoptosis and allowing the body’s natural repair mechanisms to work.
As far back as the 1950s, doctors in Scandinavia and parts of the former Soviet Union had used cold water baths to lower
the body temperature of asphyxiated babies – but no controlled trials had ever been undertaken.
Two lines of research were started by Professor Gluckman and his colleagues in the early 1980s that culminated in the
development of the CoolCap.
Firstly with Professor Tania Gunn in 1982 he started studies to evaluate the role of temperature change at birth in
determining body function. Secondly with Associate Professor Alistair Gunn and others in the mid 1980s, he developed
methods to study brain damage at the time of birth.
This led to the finding by Professor Gluckman and others of the window of opportunity for therapy. In the early 1990s
these two tracks of research came together and led to the finding that lowering a baby’s body temperature slowed the
metabolism and could act as protection against brain damage. Following animal studies, a clinical device was developed
and its safety confirmed. This knowledge formed the basis of the systematic investigation by the CoolCap research team.
By 1994, CoolCap pilot studies began, led by the late Professor Tania Gunn. Results illustrated the importance of very
early application of the treatment, and maintaining its use until all the damage processes triggered by the initial
injury had resolved.
The results of this pilot study formed the basis of subsequent clinical trials.