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A study of treatment for perinatal asphyxia

TOBY. A study of treatment for perinatal asphyxia. Sponsored by the. What now?. Clinical Co-ordinating Centre Imperial College London Department of Paediatrics Hammersmith Hospital DuCane Road, London W12 0NN. Data Co-ordinating Centre National Perinatal Epidemiology Unit

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A study of treatment for perinatal asphyxia

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  1. TOBY A study of treatment for perinatal asphyxia Sponsored by the What now? Clinical Co-ordinating Centre Imperial College London Department of Paediatrics Hammersmith Hospital DuCane Road, London W12 0NN Data Co-ordinating Centre National Perinatal Epidemiology Unit Institute of Health Sciences Old Road, Headington Oxford OX3 7LF

  2. TOBY A study of treatment for perinatal asphyxia • RCT of whole body cooling to 33.5oC for 72 hours • Selection criteria similar to Coolcap (ie includes aEEG) • Minimisation by aEEG severity and treatment centre • Primary outcome same as Coolcap (ie death or severe disability at 18 months)

  3. Whole body cooling using a manually controlled cooling blanket Tecotherm, Teccom Germany

  4. TOBY A study of treatment for perinatal asphyxia • Planned study size: 236 infants • Planned recruitment period • Feasibility phase: December 2002 to March 2004 • Continuation phase: to December 2006 • Target recruitment reached February 2006 • Recruitment ended 30th November 2006– 325 infants enrolled

  5. TOBY 325 A study of treatment for perinatal asphyxia

  6. TOBY A study of treatment for perinatal asphyxia • TOBY results will be available end of 2008 • Should infants be offered cooling after TOBY? • Who should provide cooling and how?

  7. Data from published studies

  8. Randomised trials of cooling following perinatal asphyxia

  9. The ‘CoolCap’

  10. The ‘CoolCap’ study - results

  11. The ‘CoolCap’ study - results

  12. Whole body cooling using a servo controlled cooling blanket Temperature swings noted in experimental study improved by addition of large blanket Pediatrics 2002 (110) 377-385

  13. Whole body cooling – the NICHD study *0.76 (0.60-0.97) when adjusted by centre and severity of encephalopathy

  14. Speculative meta-analysis from corrected primary analysis

  15. Meta-analysisof hypothermia: mortality

  16. Meta-analysisof hypothermia: severe disability

  17. Death or disability following moderate encephalopathy

  18. Death or disability following severe encephalopathy

  19. Current Plans of TOBY

  20. TOBY Plans following end of recruitment • New protocol and guidance for centres wishing to provide cooling in interim • Modified TOBY data collection forms • Discussion with UK Neonatal Networks to plan service • Assist training for new centres

  21. TOBY Register • AIMS • Determine the likely demand in the UK for treatment of newborn infants with cooling • Identify adverse events associated with treatment with cooling • Ensure uniform clinical management to a high standard in this high risk group of infants • Promote clinical research

  22. TOBY Register Started 1st December 2006 http://www.npeu.ox.ac.uk/tobyregister

  23. TOBY Register • Subject Group • Similar to TOBY • Data Collection • Modified from those used in TOBY • Outcome • MRI • Questionnaire at 2 yrs

  24. Future studies - TOBYplus • Programme of preliminary studies of hypothermia plus other interventions: • Topiramate • Bumetanide • Melatonin • Acetylcysteine

  25. Conclusion • Hypothermia probably improves outcome following asphyxia – but data from ongoing studies and on longer follow up is needed • Neonatal consultants wish to offer cooling with the Tecotherm system ‘off label’ pending the results of TOBY and other studies.

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