Ethics and hypothermia treatment

Seminars in Fetal and Neonatal Medicine

Volumn 15, Issue 5, 2010, Pages 299-304

  Wyatt, John S ^a  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

Clinical decision making; Informed consent; Neonatal encephalopathy; Therapeutic hypothermia; Withdrawal of treatment

Indexed keywords

ADVERSE OUTCOME; ARTICLE; BRAIN DISEASE; CEREBRAL PALSY; CLINICAL DECISION MAKING; COOLING; CRITICAL ILLNESS; ELECTROENCEPHALOGRAPHY; ETHICS; HUMAN; INDUCED HYPOTHERMIA; INFANT; INFORMED CONSENT; NEONATOLOGY; NEUROPROTECTION; NEWBORN; NEWBORN HYPOXIA; PARENTAL CONSENT; PATIENT SAFETY; PROGNOSIS; SURVIVAL; TREATMENT OUTCOME;

ASPHYXIA NEONATORUM; CLINICAL PROTOCOLS; ETHICS, MEDICAL; HUMANS; HYPOTHERMIA, INDUCED; HYPOXIA-ISCHEMIA, BRAIN; INFANT, NEWBORN; INTENSIVE CARE UNITS, NEONATAL; POSTNATAL CARE;

EID: 77956056237     PISSN: 1744165X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.siny.2010.03.002     Document Type: Article

References (39)

1. Perlman J.M. Intrapartum hypoxic-ischemic cerebral injury and subsequent cerebral palsy: medicolegal issues. Pediatrics 1997, 99:851-859.
2. Gunn A.J., Gunn T.R. Changes in risk factors for hypoxic-ischaemic seizures in term infants. Aust NZ J Obstet Gynaecol 1997, 37:36-39.
3. Gunn A.J., Gunn T.R. The 'pharmacology' of neuronal rescue with cerebral hypothermia. Early Hum Dev 1998, 53:19-35.
4. Elliott R.I., Mann T.P. Neonatal cold injury due to accidental exposure to cold. Lancet 1957, 272:229-234.
5. Bower B.D., Jones L.F., Weeks M.M. 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 P.D., Wyatt J.S., Azzopardi D., et al. Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial. Lancet 2005, 365:663-670.
8. Azzopardi D.V., Strohm B., Edwards A.D., 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 2006, TOBY Office, Oxford. http://www.npeu.ox.ac.uk/downloads/toby/TOBY-Protocol.pdf.
10. Shankaran S., Laptook A.R., Ehrenkranz R.A., 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 M.C., Nadkarni V.M., Ward F.R., Nelson R.M. 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 S.M., Rao S., Patole S.K. A systematic review of cooling for neuroprotection in neonates with hypoxic ischemic encephalopathy-are we there yet?. BMC Pediatr 2007, 7:30.
17. Shah P.S., Ohlsson A., Perlman M. Hypothermia to treat neonatal hypoxic ischemic encephalopathy: systematic review. Arch Pediatr Adolesc Med 2007, 161:951-958.
18. Edwards A.D., Brocklehurst P., Gunn A.J., 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 D.J. Cool heads: ethical issues associated with therapeutic hypothermia for newborns. Acta Paediatr 2009, 98:217-220.
20. Ziino A.J. Palliation bias is being overlooked in neonatal hypothermia trials. Arch Dis Child Fetal Neonatal Ed 2006, 91:F464-F465.
21. Gunn A.J., Wyatt J.S., Whitelaw A., et al. Therapeutic hypothermia changes the prognostic value of clinical evaluation of neonatal encephalopathy. J Pediatr 2008, 152:55-58. CoolCap Study Group.
22. Rutherford M., Ramenghi L.A., Edwards A.D., 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 R.D., Raju T.N., 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 W.A. Personal reflections on lessons learned from randomized trials involving newborn infants from 1951 to 1967. Clin Trials 2004, 1:179-184.
26. Robertson A.F. Reflections on errors in neonatology III. The " experienced" years, 1970 to 2000. J Perinatol 2003, 23:240-249.
27. Aberegg S.K., Haponik E.F., Terry P.B. Omission bias and decision making in pulmonary and critical care medicine. Chest 2005, 128:1497-1505.
28. Baron J., Holzman G.B., 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 N.J. 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 P.S. Ethics of therapeutic hypothermia. Acta Paediatr 2009, 98:211-213.
33. Iwata O., Iwata S., Thornton J.S., 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 C.M., Finer N.N. Long-term follow-up of term neonates with perinatal asphyxia. Clin Perinatol 1993, 20:483-500.
35. Bona E., Hagberg H., Løberg E.M., 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 N.J., 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 N.J. Therapeutic hypothermia for neonatal encephalopathy; implications for neonatal units in India. Indian Pediatr 2009, 46:283-289.
39. Horn A.R., Harrison M.C., Linley L.L. Evaluating a simple method of neuroprotective hypothermia for newborn infants. J Trop Pediatr 2009 Sep 30, [Epub ahead of print].