TOBY Trial - whole body cooling for babies born with neonatal encephalopathy
Moderate or severe perinatal asphyxial encephalopathy occurs in approximately 2/1000 births and is associated with an increased risk of death or neurodevelopmental impairments. Approximately 25% of infants with moderate encephalopathy will develop cerebral palsy, while almost all infants with severe encephalopathy die or survive with multiple disabilities. When the TOBY trial was being planned there were no treatments for perinatal asphyxial encephalopathy which improved these outcomes.
This multicentre, randomised trial investigated whether a reduction of body temperature by 3-4 degrees centigrade in full term infants with moderate or severe perinatal asphyxial encephalopathy would be a safe, cost-effective, treatment that may improve survival without neurodevelopmental impairments.
Recruitment finished on 30th November 2006; 325 babies were recruited and were followed up until 18 months of age. Information is available for 99% of the surviving children.
A paper describing the outcomes of the study until 18 months of age has been published in the New England Journal of Medicine.
A meta-analysis of the major cooling trials was then published in the British Medical Journal and in May 2010 the National Institute for Health and Clinical Excellence recommended the use of moderate therapeutic hypothermia for the treatment of neonatal encephalopathy in term infants.