Cool heads: Ethical issues associated with therapeutic hypothermia for newborns

Acta Paediatrica, International Journal of Paediatrics

Volumn 98, Issue 2, 2009, Pages 217-220

  Wilkinson, Dominic J ^a,b  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

Brain; Clinical; Ethics; Hypothermia; Hypoxia ischemia; Induced; Infant; Newborn

Indexed keywords

COOLING; EVIDENCE BASED MEDICINE; HEALTH CARE PERSONNEL; HUMAN; HYPOTHERMIA; LIFE SUSTAINING TREATMENT; MEDICAL ETHICS; MEDICAL PRACTICE; MEDICAL RESEARCH; NEWBORN; PALLIATIVE THERAPY; PRIORITY JOURNAL; PROGNOSIS; REVIEW;

HUMANS; HYPOTHERMIA, INDUCED; HYPOXIA-ISCHEMIA, BRAIN; INFANT, NEWBORN;

EID: 58449114141     PISSN: 08035253     EISSN: 16512227     Source Type: Journal    
DOI: 10.1111/j.1651-2227.2008.01127.x     Document Type: Review

References (34)

1. Lawn JE, Cousens S, Zupan J, Team LNSS. 4 million neonatal deaths: when? Where? Why? Lancet 2005 365 : 891 900.
2. Shankaran S, Laptook AR. Hypothermia as a treatment for birth asphyxia. Clin Obstet Gynecol 2007 50 : 624 35.
3. Shah P, Ohlsson A, Perlman M. Hypothermia to treat neonatal hypoxic ischemic encephalopathy: systematic review. Arch Pediatr Adolesc Med 2007 161 : 951 8.
4. Gluckman PD, Wyatt JS, Azzopardi D, Ballard R, Edwards AD, Ferriero DM, et al. Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial. Lancet 2005 365 : 663 70.
5. Shankaran S, Laptook AR, Ehrenkranz RA, Tyson JE, McDonald SA, Donovan EF, et al. Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy. N Engl J Med 2005 353 : 1574 84.
6. Jacobs S, Hunt R, Tarnow-Mordi W, Inder T, Davis P. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane database of systematic reviews (Online). 2007 : CD003311.
7. 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.
8. Gunn AJ, Hoehn T, Hansmann G, Bührer C, Simbruner G, Yager J, et al. Hypothermia: an evolving treatment for neonatal hypoxic ischemic encephalopathy. Pediatrics 2008 121 : 648 9 author reply 649-50.
9. Perlman M, Shah P. Time to adopt cooling for neonatal hypoxic-ischemic encephalopathy: response to a previous commentary. Pediatrics 2008 121 : 616 8.
10. Kirpalani H, Barks J, Thorlund K, Guyatt G. Cooling for neonatal hypoxic ischemic encephalopathy: do we have the answer? Pediatrics. 2007 120 : 1126 30.
11. Perlman JM. Hypothermia as a therapeutic intervention in term infants with neonatal encephalopathy-Is it ready for prime time? Resuscitation 2008 78 : 1 2.
12. Hoehn T, Hansmann G, Bührer C, Simbruner G, Gunn AJ, Yager J, 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.
13. McKinlay JB. From "promising report" to "standard procedure": seven stages in the career of a medical innovation. The Milbank Memorial Fund Quarterly Health and Society 1981 59 : 374 411.
14. Silverman WA. Informed consent in customary practice and in clinical trials. In : Goldworth A, Silverman WA, Stevenson DK, Young EWD, editors. Ethics and perinatology. New York; Oxford : Oxford University Press 1995.
15. Robertson A. Reflections on errors in neonatology III. The "experienced" years, 1970 to 2000. J. Perinatol 2003 23 : 240 9.
16. Silverman WA. Human experimentation: a guided step into the unknown. Oxford : Oxford University Press 1985.
17. Chalmers I. The scandalous failure of science to cumulate evidence scientifically. Clin Trials 2005 2 : 229 31.
18. Bostrom N, Ord T. The reversal test: eliminating status quo bias in applied ethics. Ethics 2006 116 : 656 79.
19. Aberegg SK, Haponik EF, Terry PB. Omission bias and decision making in pulmonary and critical care medicine. Chest 2005 128 : 1497 505.
20. Mchaffie HE, Laing IA, Parker M, Mcmillan J. Deciding for imperilled newborns: medical authority or parental autonomy? J Med Ethics 2001 27 : 104 9.
21. Gunn AJ, Gluckman PD. Head cooling for neonatal encephalopathy: the state of the art. Clin Obstet Gynecol 2007 50 : 636 51.
22. Polderman KH, Girbes AR. Hypothermia for neonates with hypoxic-ischemic encephalopathy. N Engl J Med 2006 354 : 1643 5.
23. Higgins RD, Raju TN, Perlman J, Azzopardi DV, Blackmon LR, Clark RH, et al. Hypothermia and perinatal asphyxia: Executive summary of the National Institute of Child Health and Human Development workshop. J Pediatr 2006 148 : 170 5.
24. Zanelli SA, Naylor M, Dobbins N, Quigg M, Goodkin HP, Matsumoto JA, et al. Implementation of a 'Hypothermia for HIE' program: 2-year experience in a single NICU. J Perinatol 2008 28 : 171 5.
25. Altman DG, Bland JM. Statistics Notes: Generalisation and extrapolation. BMJ 1998 317 : 409 10.
26. Assmann SF, Pocock SJ, Enos LE, Kasten LE. Subgroup analysis and other (mis) uses of baseline data in clinical trials. Lancet 2000 355 : 1064 9.
27. Shah PS, Beyene J, To T, Ohlsson A, Perlman M. Postasphyxial hypoxic-ischemic encephalopathy in neonates: outcome prediction rule within 4 hours of birth. Arch Pediatr Adolesc Med 2006 160 : 729 36.
28. Wilkinson DJ, Fitzsimons JJ, Dargaville PA, Campbell NT, Loughnan PM, McDougall PN, et al. Death in the neonatal intensive care unit: changing patterns of end of life care over two decades. Arch Dis Child Fetal Neonatal Ed 2006 91 : F268 71.
29. Carter BS, Leuthner SR. The ethics of withholding/withdrawing nutrition in the newborn. Semin Perinatol 2003 27 : 480 7.
30. Shevell MI, Majnemer A, Miller SP. Neonatal neurologic prognostication: the asphyxiated term newborn. Pediatr Neurol 1999 21 : 776 84.
31. Gunn AJ, Wyatt JS, Whitelaw A, Barks J, Azzopardi D, Ballard R, et al. Therapeutic hypothermia changes the prognostic value of clinical evaluation of neonatal encephalopathy. J Pediatr 2008 152 : 55 8.
32. http://www.npeu.ox.ac.uk/tobyregister
33. Ellenberg JH. Selection bias in observational and experimental studies. Stat Med 1994 13 : 557 67.
34. Luepker RV. Observational studies in clinical research. J Lab Clin Med 2005 146 : 9 12.