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
Manual of Procedures