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  1. Although a model is low-cost its transfer from developed to developing countries is not necessarily a priority

    Dear Editor,

    During the past five years, therapeutic hypothermia (TH) was shown to be effective and safe in improving neurodevelopmental outcome after hypoxic ischaemic encephalopathy (HIE) in newborns.(1) The use of this therapy has been rapidly incorporated into clinical practice in many countries, even though many doubts related to clinical management and monitoring remain unanswered.(2) The lack of a national approach to TH, such as its inclusion in protocols shared among NICUs, is widely recognized.(3)
    TH is employed in 1-3/1000 births in the north of the world and is 10-20 times more frequent in low resources settings. In such critical contexts, TH may be useful, but its utility needs to be proven. Wilkinson et al. addressed the difficulties in applying trial results from developed to developing countries and underlined the need for formal, randomized controlled trials of TH in low- and middle income countries.(4)
    The problem with transferring findings from an experimental context to clinical practice is one of the major challenges of modern evidence based medicine and TH is a fitting example. TH is effective if:
    a) the management of multiorgan dysfunction is guaranteed;
    b) appropriate interventions to confirm the diagnosis and routinely monitor cerebral function are carried out;
    c) counseling and support to the family are provided.
    These are the essential responsibilities and rights that must be present when TH is employed, both in the North and South of the world.
    Difficulties in generalizing TH are still present in the North and are amplified in the South, where priorities and resources are different. There are low-cost interventions shown to be effective in reducing neonatal death and perinatal impairment outcomes in developing countries that must be implemented, diffused, and adequately monitored over the time.(5) According to the principles of equity, a global use of TH should be expected if and when other essential procedures are guaranteed.
    Thus, ethical and practical priorities, especially in settings in which HIE occurs more often (i.e. rural or isolated villages), suggest that, before focusing on randomized controlled trials of TH, more effective means to provide and guarantee basic perinatal care over time in order to reduce HIE and the need for its treatment must be met.

    Reference

    1. Azzopardi D. Clinical management of the baby with hypoxic ischaemic encephalopathy. Early Human Develp 2010; 86:345-50.

    2. Barks JD. Current controversies in hypothermic neuroprotection. Semin Fetal Neonatal Med 2008; 13:30-4.

    3. Allen NM, Foran A, O'Donovan DJ. Neonatal therapeutic hypothermia: practice and opinions in the Republic of Irealand. Arch Dis Child Fetal Neonatal Ed doi:10.1136/adc.2010.195354.

    4. Wilkinson DJ, Thayyil S, Robertson NJ. Ethical and practical issues relating to the global use of therapeutic hypothermia for perinatal asphyxia encephalopathy. Arch Dis Child Fetal Neonatal Ed 2011;96 F75-F78.

    5. Waldemar CA et al. Newborn-care training and perinatal mortality in developing countries. N Engl J Med 2010; 362:614-23.

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