Although therapeutic hypothermia is widely used in India and other low and middle-income countries, the safety and efficacy of this therapy has not been evaluated in an adequately powered randomized control trial. The aim of the HELIX trial was to examine if therapeutic hypothermia alongside optimal supportive neonatal intensive care reduces death or disability at 18 months in babies with moderate or severe neonatal encephalopathy in low and middle-income countries.

 

Seven tertiary neonatal centres in India, Sri Lanka and Bangladesh with facilities for adequate supportive including ventilation and inotropic support were involved in the trial. Four hundred and eight infants with moderate or severe encephalopathy were recruited between Aug 2015 and Feb 2019. 202 infants were assigned to the hypothermia group and 206 to the control group. All infants had 3 Tesla MR imaging and spectroscopy at 2 weeks and detailed neurodevelopmental assessment at 18 to 22 months using Bayley scales of infant and toddler development (version 3).

 

Primary outcome was death or moderate or severe disability at 18 months and were available for 195 (97%) of the 202 infants in the hypothermia group and 199 (97%) of the 206 control group infants.

 

At 18 months, 98 (50%) infants in the hypothermia group and 94 (47%) infants in the control group died or had a moderate or severe disability (risk ratio 1·06; 95% CI 0·87–1·30; p=0·55). 84 infants (42%) in the hypothermia group and 63 (31%; p=0·022) infants in the control group died. No reduction in brain injury was seen on conventional MR imaging, MR spectroscopy or whole brain fractional anisotropy.

 

In conclusion, Therapeutic hypothermia did not reduce the combined outcome of death or disability at 18 months after neonatal encephalopathy in low-income and middle-income countries but significantly increased mortality.

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