UK TOBY Cooling Register: register of the use of moderate hypothermia in neonates

Summary

The TOBY Study (see 1.1.4), which was funded by the Medical Research Council, stopped recruitment at the end of November 2006. It was anticipated that some of the TOBY collaborators would choose to offer cooling treatment outside of the trial setting, this proved to be the case.

This Register was established in December 2006 in order to collect data on any episode of treatment with cooling for neonatal encephalopathy (NE) in the UK. At that time, cooling treatment for NE was not a standard treatment, but it was used regularly in some neonatal intensive care units, with at least 104 episodes occurring during the first year of the Register's activity.

In May 2010, the National Institute for Health and Clinical Excellence recommended therapeutic hypothermia for term infants with NE, following the publication of the TOBY Study results and subsequently a systematic review of the 3 major cooling trials.

More neonatal units offered cooling as a result and in 2010, 2011 and 2012 well over 800 treatment episodes were registered each year. Over 70 neonatal units registered cooled infants in the UK and Eire.

The aims of this project were to determine the demand in the UK for the treatment of newborn infants with cooling; identify adverse events associated with cooling treatment; ensure uniform clinical management to a high standard and support further research into neuroprotection following perinatal asphyxia.

This was an anonymous register. Detailed data were collected for the first four days covering the cooling and rewarming period, with summary information on the remainder of the hospital admission. Information on health status at 2 years were also collected.

By 2012 cooling was an established standard treatment for term infants with neonatal encephalopathy, and could therefore become part of routine audit within Trusts and established neonatal audit systems. Registration of cooled infants ceased on 31 December 2012.

Detailed information about the Register and protocols for cooling treatment (including transport procedures and passive cooling) were available on our website until October 2015, when the Register web-pages were archived as the resources were not available to ensure that the clinical advice remained current.

Publications

Journal Articles

• Azzopardi D, Strohm B, Edwards AD, Halliday H, Juszczak E, Levene M, Thoresen M, Whitelaw A, Brocklehurst P. Treatment of asphyxiated newborns with moderate hypothermia in routine clinical practice: how cooling is managed in the UK outside a clinical trial. Arch Dis Child Fetal Neonatal Ed. 2009;94(4):F260-F4.
• Strohm B. Cooling for neonatal encephalopathy in 2010. Infant. 2010;6(4):123-7.
• Strohm B, Azzopardi D. Temperature control during therapeutic moderate whole-body hypothermia for neonatal encephalopathy. Arch Dis Child Fetal Neonatal Ed. 2010;95(5):F373-F5.
• Strohm B, Hobson A, Brocklehurst P, Edwards AD, Azzopardi D. Subcutaneous Fat Necrosis After Moderate Therapeutic Hypothermia in Neonates. Pediatrics. 2011;128(2):e450-e2.
• Azzopardi D, Strohm B, Linsell L, Hobson A, Juszczak E, Kurinczuk JJ, Brocklehurst P, Edwards AD, on behalf of the UKTCR. Implementation and Conduct of Therapeutic Hypothermia for Perinatal Asphyxial Encephalopathy in the UK ? Analysis of National Data. PLoS One. 2012;7(6):e38504.