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Active and Completed Studies > Hypothermia > Documents

The NICHD randomized controlled trial on whole body hypothermia for neonatal hypoxic-ischemic encephalopathy (HIE) demonstrated safety and effectiveness in reducing the risk of death and disability among infants with moderate or severe encephalopathy. Rigorous criteria were used to define moderate and severe encephalopathy and the NRN centers used certified and trained examiners and personnel to implement and monitor the study interventions and outcome.

Therapeutic hypothermia should be used only under published protocols, or as part of ongoing controlled trials of induced hypothermia for HIE.

Institutions offering hypothermia in non-research settings need to document clinical data in a systematic way and ensure long term follow-up of treated infants using standardized follow-up protocols developed by centers conducting hypothermia trials and preferably submit information to registries.

Clinicians choosing to offer this treatment should therefore understand the available evidence and knowledge gaps in this potentially promising therapy for HIE. They should be prepared to keep up-to -date on evidence of this topic as it evolves and counsel parents about limitations of current evidence.

"Shankaran S, Laptook AR, Ehrenkranz RE et al. Whole body hypothermia in neonates with hypoxic-ischemic encephalopathy. N Engl J Med: 2005: 353;174-84"

The statements expressed above are solely those of the study investigators and do not necessarily reflect the views of RTI. RTI accepts no legal liability or responsibility whatsoever for any claims made or opinions expressed herein.

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