The UK TOBY Cooling Register was established in December 2006, at the end of recruitment to the TOBY Study and prior to the final trial results becoming available in 2009.
At that time it was an innovative evolving therapy and many neonatal units wished to offer cooling as a treatment for babies born with neonatal encephalopathy.
The Register was set up to provide clinical guidance in order to promote uniform practice, to avoid inappropriate treatment and to foster continuing collaboration in future studies of neuroprotection following asphyxia.
Cooling was recommended as standard care for appropriate infants by the National Institute for Health and Care Excellence (NICE guidance) in 2010.
The aims of the Register were:
to determine the likely demand in the UK for treatment of newborn infants with cooling
to identify adverse events associated with treatment with cooling
to ensure uniform clinical management to a high standard in a high risk group of infants
to support further clinical trials of neuroprotection following asphyxia
The Register ceased activity in 2012, by which time therapeutic hypothermia was well established as a standard treatment and neonatal units and networks in the UK had their own guidelines and protocols, which are updated locally. While active, the Register recorded data from over 3300 cases of neonatal hypothermia treatment and several publications were produced.
Register material remained publically available on the website until September 2015, when the Register web-pages were archived as the resources are not available to ensure that the clinical advice remains current.
Any queries relating to the Register should be sent to the NPEU Clinical Trials Unit: