Current controversies in hypothermic neuroprotection.

In 2005, three randomised controlled trials (RCTs) showed that treating infants with hypoxic-ischaemic encephalopathy (HIE) with hypothermia decreased the combined outcome of death or disability at 12-18 months, although treatment effects were modest. More recently, the US Food and Drug Administration (FDA) approved a device for selective head cooling. In addition, the protocol from another of the three trials, using equipment available in many hospitals, has been in the public domain for over a year. Why has this not led to a consensus that hypothermia is the standard of care for HIE? This is explored. Important questions for future research will focus on ways to improve on initial results with cooling, such as drug plus hypothermia combination therapy and refining duration and depth of cooling or duration of rewarming. Although the latter are important questions for future clinical trials, those who are convinced by the evidence to date should focus on safe implementation of cooling using protocols with established safety and efficacy and should consider ways to increase access to cooling for eligible babies.