Ethical challenges in the use of therapeutic hypothermia in Indian neonatal units.

Trials in developed countries have shown that therapeutic hypothermia reduces the risk of death or severe disability in infants with neonatal encephalopathy. Cooling has been adopted as a standard of care in some parts of the world. Some Indian neonatal units have considered or even embarked upon cooling encephalopathic term newborn infants. In this article we discuss some of the potential ethical questions that should be considered before introducing therapeutic hypothermia in an Indian setting. Evidence from previous trials may not be relevant given significant differences in the epidemiology of neonatal encephalopathy in countries like India. There is a possibility that hypothermia would be ineffective or harmful. The most appropriate way to answer these concerns would be to perform a large randomized controlled trial of cooling in India. However, such trials will also raise potential ethical challenges. Cooling may also affect decisions about treatment withdrawal, and may create uncertainty about prognosis. It may exacerbate ethical problems relating to lack of neonatal intensive care bed space.