A systematic review of several large multi-centre RCTs for therapeutic cooling to treat hypoxic-ischaemic encephalopathy included:
- Cool Cap (2005, 234 infants, head cooling only);
- NICHD (2005, 208 infants);
- TOBY (2009, 325 infants).
It showed a statistically significant reduction in the combined outcome of mortality or major neurodevelopmental disability to 18 months of age (RR 0.75; 95% CI 0.68 to 0.83), and in each of these outcomes alone (i.e. cooling reduces mortality without increasing major disability in survivors).
Adverse effects include sinus bradycardia and thrombocytopenia.
Reference: Jacobs SE, Berg M, Hunt R, Tarnow-Mordi WO, Inder TE, Davis PG. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database of Systematic Reviews 2013, Issue 1. Art. No.: CD003311. DOI: 10.1002/14651858.CD003311.pub3.