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Background: The CoolCap Trial

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.

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