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Hypothermia therapy for neonatal encephalopathy

Hypothermia therapy for neonatal encephalopathy
Intervention
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Brain hypothermia, induced by cooling a baby to around 33 °C for three days after birth, is a treatment for hypoxic ischemic encephalopathy. It has recently been proven to be the only medical intervention which reduces brain damage, and improves an infant's chance of survival and reduced disability. Hypoxic ischemic encephalopathy has many causes and is essentially the reduction in the supply of blood or oxygen to a baby's brain before, during, or even after birth. It is a major cause of death and disability, occurring in approximately 2–3 per 1000 births and causing around 20% of all cases of cerebral palsy.

A 2013 Cochrane review found that therapeutic hypothermia is useful in full term babies with encephalopathy.

Studies have been undertaken to determine the effects of hypothermia beyond early childhood. Participants in the CoolCap, NICHD and TOBY trials were entered into extended follow-up programmes. None of these programmes have sufficient power to make confident assessments of the long-term effect of hypothermia, however even these underpowered studies give important information on whether the therapeutic effects of cooling are sustained beyond the first two years after birth.

The most significant follow-up study published so far is the assessment of the NICHD trial participants at 6–7 years. Of the 208 trial participants, primary outcome data were available for 190. Of the 97 children in the hypothermia group and the 93 children in the control group, death or an IQ score below 70 occurred in 46 (47%) and 58 (62%), respectively (P=0.06); death occurred in 27 (28%) and 41 (44%) (P=0.04); and death or severe disability occurred in 38 (41%) and 53 (60%) (P=0.03). The CoolCap study gathered data using the WeeFim questionnaire at 7–8 years of age, but only collected information on 62 (32 cooled; 30 standard care) of 135 surviving children who had had neurodevelopmental assessment at 18 months. Disability status at 18 months was strongly associated with WeeFIM ratings (P < 0.001) suggesting that the therapeutic effect persisted, but there was no significant effect of treatment (P = 0.83).

These results were not quite conclusive, as the effect in the NICHD trial appears to be on mortality rather than neurological function, but they gave considerable confidence that the therapeutic effects of hypothermia following birth asphyxia are sustained into later childhood, and the preliminary childhood outcomes of the Toby trial presented at the Hot Topics in Neonatology meeting in Washington DC in December 2013 appear to confirm persisting benefit of treatment on neurological function; these data await peer review and formal publication and if confirmed would provide the definitive data needed for evidence-based health policy decisions.


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