Seminars in Fetal & Neonatal Medicine
Volume 15, Issue 5 , Pages 299-304 , October 2010

Ethics and hypothermia treatment

  • John S. Wyatt

      Affiliations

    • Corresponding Author InformationTel.: +44 20 8800 3018; fax: +44 20 7679 6103.

References 

  1. Perlman JM. Intrapartum hypoxic–ischemic cerebral injury and subsequent cerebral palsy: medicolegal issues. Pediatrics. 1997;99:851–859
  2. Gunn AJ, Gunn TR. Changes in risk factors for hypoxic–ischaemic seizures in term infants. Aust NZ J Obstet Gynaecol. 1997;37:36–39
  3. Gunn AJ, Gunn TR. The ‘pharmacology’ of neuronal rescue with cerebral hypothermia. Early Hum Dev. 1998;53:19–35
  4. Elliott RI, Mann TP. Neonatal cold injury due to accidental exposure to cold. Lancet. 1957;272:229–234
  5. Bower BD, Jones LF, Weeks MM. Cold injury in the newborn. A study of 70 cases. Br Med J. 1960;1(5169):303–309
  6. Schubert A. Side effects of mild hypothermia. J Neurosurg Anesthesiol. 1995;7:139–147
  7. Gluckman PD, Wyatt JS, Azzopardi D, et al. Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial. Lancet. 2005;365:663–670
  8. Azzopardi DV, Strohm B, Edwards AD, et al. Moderate hypothermia to treat perinatal asphyxial encephalopathy. N Engl J Med. 2009;361:1349–1358
  9. Anonymous . TOBY study protocol. Whole body hypothermia for the treatment of perinatal asphyxial encephalopathy. Oxford: TOBY Office; 2006;http://www.npeu.ox.ac.uk/downloads/toby/TOBY-Protocol.pdf
  10. Shankaran S, Laptook AR, Ehrenkranz RA, et al. Whole-body hypothermia for neonates with hypoxic–ischemic encephalopathy. N Engl J Med. 2005;353:1574–1584
  11. Thoresen M, Penrice J, Lorek A, et al. Mild hypothermia after severe transient hypoxia–ischemia ameliorates delayed cerebral energy failure in the newborn piglet. Pediatr Res. 1995;37:667–670
  12. Whitelaw A, Thoresen M. Clinical trials of treatments after perinatal asphyxia. Curr Opin Pediatr. 2002;14:664–668
  13. Morris MC, Nadkarni VM, Ward FR, Nelson RM. Exception from informed consent for pediatric resuscitation research: community consultation for a trial of brain cooling after in-hospital cardiac arrest. Pediatrics. 2004;114:776–781
  14. Allmark P, Mason S. Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process. J Med Ethics. 2006;32:439–443
  15. Jacobs S, Hunt R, Tarnow-Mordi W, et al. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database Syst Rev. 2007;(4):CD003311, doi:10.1002/14651858.CD003311.pub2
  16. Schulzke SM, Rao S, Patole SK. A systematic review of cooling for neuroprotection in neonates with hypoxic ischemic encephalopathy–are we there yet?. BMC Pediatr. 2007;7:30
  17. Shah PS, Ohlsson A, Perlman M. Hypothermia to treat neonatal hypoxic ischemic encephalopathy: systematic review. Arch Pediatr Adolesc Med. 2007;161:951–958
  18. Edwards AD, Brocklehurst P, Gunn AJ, et al. Neurological outcomes at 18 months of age after moderate hypothermia for perinatal hypoxic ischaemic encephalopathy: synthesis and meta-analysis of trial data. Br Med J. 2010;340:c363
  19. Wilkinson DJ. Cool heads: ethical issues associated with therapeutic hypothermia for newborns. Acta Paediatr. 2009;98:217–220
  20. Ziino AJ. Palliation bias is being overlooked in neonatal hypothermia trials. Arch Dis Child Fetal Neonatal Ed. 2006;91:F464–F465
  21. Gunn AJ, Wyatt JS, Whitelaw A, et al. CoolCap Study Group Therapeutic hypothermia changes the prognostic value of clinical evaluation of neonatal encephalopathy. J Pediatr. 2008;152:55–58
  22. Rutherford M, Ramenghi LA, Edwards AD, et al. Assessment of brain tissue injury after moderate hypothermia in neonates with hypoxic–ischaemic encephalopathy: a nested substudy of a randomised controlled trial. Lancet Neurol. 2010;9:39–45
  23. Higgins RD, Raju TN, Perlman J, et al. Hypothermia and perinatal asphyxia: executive summary of the National Institute of Child Health and Human Development workshop. J Pediatr. 2006;148:170–175
  24. Kirpalani H, Barks J, Thorlund K, Guyatt G. Cooling for neonatal hypoxic ischemic encephalopathy: do we have the answer?. Pediatrics. 2007;120:1126–1130
  25. Silverman WA. Personal reflections on lessons learned from randomized trials involving newborn infants from 1951 to 1967. Clin Trials. 2004;1:179–184
  26. Robertson AF. Reflections on errors in neonatology III. The “experienced” years, 1970 to 2000. J Perinatol. 2003;23:240–249
  27. Aberegg SK, Haponik EF, Terry PB. Omission bias and decision making in pulmonary and critical care medicine. Chest. 2005;128:1497–1505
  28. Baron J, Holzman GB, Schulkin J. Attitudes of obstetricians and gynecologists toward hormone replacement therapy. Med Decis Making. 1998;18:406–411
  29. Kapetanakis A, Azzopardi D, Wyatt J, Robertson NJ. Therapeutic hypothermia for neonatal encephalopathy: a UK survey of opinion, practice and neuro-investigation at the end of 2007. Acta Paediatr. 2009;98:631–635
  30. International Liaison Committee on Resuscitation . 2005 International Consensus on cardiopulmonary resuscitation and emergency cardiovascular care science with treatment recommendations. Part 7: neonatal resuscitation. Resuscitation. 2005;67:293–303
  31. Hoehn T, Hansmann G, Bührer C, et al. Therapeutic hypothermia in neonates. Review of current clinical data, ILCOR recommendations and suggestions for implementation in neonatal intensive care units. Resuscitation. 2008;78:7–12
  32. Perlman M, Shah PS. Ethics of therapeutic hypothermia. Acta Paediatr. 2009;98:211–213
  33. Iwata O, Iwata S, Thornton JS, et al. “Therapeutic time window” duration decreases with increasing severity of cerebral hypoxia–ischaemia under normothermia and delayed hypothermia in newborn piglets. Brain Res. 2007;1154:173–180
  34. Robertson CM, Finer NN. Long-term follow-up of term neonates with perinatal asphyxia. Clin Perinatol. 1993;20:483–500
  35. Bona E, Hagberg H, Løberg EM, Bågenholm R, Thoresen M. Protective effects of moderate hypothermia after neonatal hypoxia–ischemia: short- and long-term outcome. Pediatr Res. 1998;43:738–745
  36. Corbett D, Hamilton M, Colbourne F. Persistent neuroprotection with prolonged postischemic hypothermia in adult rats subjected to transient middle cerebral artery occlusion. Exp Neurol. 2000;163:200–206
  37. Robertson NJ, Nakakeeto M, Hagmann C, et al. Therapeutic hypothermia for birth asphyxia in low-resource settings: a pilot randomised controlled trial. Lancet. 2008;372:801–803
  38. Thayyil S, Costello A, Shankaran S, Robertson NJ. Therapeutic hypothermia for neonatal encephalopathy; implications for neonatal units in India. Indian Pediatr. 2009;46:283–289
  39. Horn AR, Harrison MC, Linley LL. Evaluating a simple method of neuroprotective hypothermia for newborn infants. J Trop Pediatr. 2009 Sep 30;[Epub ahead of print]

PII: S1744-165X(10)00016-8

doi: 10.1016/j.siny.2010.03.002

Seminars in Fetal & Neonatal Medicine
Volume 15, Issue 5 , Pages 299-304 , October 2010