Presented at the Neonatal Society 2011 Autumn Meeting.
Azzopardi D1, Strohm B2, Linsell L2, Hobson A2, Juszczak E2, Kurinczuk JJ2, Brocklehurst P3, Edwards AD1 on behalf of the UK TOBY Cooling Register
1 Centre for the Developing Brain, Imperial College London, UK
2 National Perinatal Epidemiology Unit, University of Oxford, UK
3 Institute for Womens Health University College London, UK
Background: Delay in implementing proven new therapies increases health and economic opportunity costs. Synthesis of randomised controlled trials, including the recent TOBY trial which was predominantly carried out in the UK showed that moderate hypothermia is a novel intervention to improve survival and neurological outcome following perinatal asphyxial encephalopathy (1).
Our objective was to use the UK TOBY Cooling Register (2) of infants treated with hypothermia to determine whether moderate hypothermia was implemented appropriately in the UK.
Methods: We compared the number of notifications to the Register between 2006 and 2011 with the expected numbers of eligible infants in the UK, and assessed compliance with recruitment and treatment guidelines.
Results: The monthly rate of notifications increased from median {IQR} 18 {15-28} to 33 {30-38} after the announcement of the results of the TOBY trial, and increased further to 54 {42-58} after their publication. This rate did not change substantially following official endorsement of the therapy and is close to the expected numbers of eligible infants (figure). From 2006 to 2011 there was evidence of minimal extension of treatment to less severely affected infants, with no significant change in the death rate of treated infants, which was close to that found in randomized trials.
Conclusion: Therapeutic hypothermia was implemented promptly within the UK, with significant benefit to patients and the health economy. This may be due in part to participation by neonatal units in clinical trials and the establishment of the national Register.
Corresponding author: d.azzopardi@imperial.ac.uk
References
1. Edwards AD, Brocklehurst P, Gunn AJ, Halliday H, Juszczak E, Levene M et al. Neurological outcomes at 18 months of age after moderate hypothermia for perinatal hypoxic ischaemic encephalopathy: synthesis and meta-analysis of trial data. BMJ 2010;340:c363.
2. www.npeu.ox.ac.uk/tobyregister