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COMMENTARY |
a Departments of Clinical Epidemiology
b Pediatrics
e Medicine, McMaster University, Hamilton, Ontario, Canada
c Department of Pediatrics, Mott Hospital, University of Michigan, Ann Arbor, Michigan
d Copenhagen Trials Unit, Copenhagen University Hospital, Copenhagen, Denmark
Abbreviations: RCT, randomized, controlled trial • HIE, hypoxemic-ischemic encephalopathy • NICHD, National Institute of Child Health and Human Development • TOBY, Trial of Whole Body Hypothermia for Perinatal Asphyxia • RR, relative risk • CI, confidence interval • aEEG, amplitude-integrated electroencephalography • ICE, Infant Cooling Evaluation
| The first 300 words of the full text of this article appear below. |
The neonatal community deserves congratulations for responding vigorously to Silverman's1 call for randomized controlled trials (RCTs) to evaluate neonatal therapies. Although more trials are still needed,2 existing RCTs present new challenges in interpretation. One of the most vexing is when to proclaim innovative therapies as "standard of care."
The neonatal critical care community faces this challenge in evaluation of hypothermia as treatment for hypoxemic-ischemic encephalopathy (HIE).3–5 National bodies have made declarations that the neonatal community should consider hypothermia experimental pending completion of current ongoing trials.6–9 Although the influence of these bodies is considerable, individual physicians and sites apparently feel pressure to "do something" in the very dire circumstances of HIE in the newborn. In an informal sample of convenience, we have found that some centers are performing cooling, either with or without informed consent. Although many clinicians concur with the leading bodies that state there is a need for additional trials, it is confusing for practicing neonatologists when some members of these bodies also publicly state that they are actively providing cooling therapy.
If leading centers are promoting active cooling, they have, in effect, adopted cooling as a standard of care. This may not only have legal implications but also raises ethical issues for those who believe the right thing to do currently is to continue performing RCTs. The countervailing argument is that to not offer cooling as standard therapy for such a devastating disease as HIE is itself, unethical. These opposing viewpoints are not easily resolvable except by considering what the overall benefit of eliminating residual doubt, one way or the other, would be. Our concern is that advocacy of hypothermia as a standard of care represents an excessively low threshold for accepting promising therapies and will ultimately lead to resources devoted to useless interventions that should be devoted
Address correspondence to Haresh Kirpalani, BM, MSc, Division of Neonatology, Children's Hospital of Philadelphia, 34th Street and Civic Center Boulevard, Philadelphia, PA 19104. E-mail: kirpalanih@email.chop.edu
This article has been cited by other articles:
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  M. Perlman and P. Shah Time to Adopt Cooling for Neonatal Hypoxic-Ischemic Encephalopathy: Response to a Previous Commentary Pediatrics, March 1, 2008; 121(3): 616 - 618. [Full Text] [PDF]
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A. J. Gunn, T. Hoehn, G. Hansmann, C. Buhrer, G. Simbruner, J. Yager, M. Levene, S. E. G. Hamrick, S. Shankaran, and M. Thoresen Hypothermia: An Evolving Treatment for Neonatal Hypoxic Ischemic Encephalopathy Pediatrics, March 1, 2008; 121(3): 648 - 649. [Full Text] [PDF]
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