Cooling for HIE – longer and deeper is not better

A randomized factorial-design trial from the Neonatal Research Network compared the effects of cooling babies with HIE to lower levels than  usual (32 degrees C instead of 33.5 degrees C) and for longer than usual (120 hours instead of 72 hours). The trial was stopped for emerging safety profile and futility analysis after approximately half the intended number of infants were enrolled, mainly because the probability of detecting a statistically significant benefit for NICU death was less than 2%. Major bleeding occurred in 1% of the 120 hours group compared to 3% in the 72 hours group. Other safety outcomes studied (cardiac arrhythmia, persistent acidosis, major vessel thrombosis, and death in the neonatal intensive care unit) were similar in the comparison groups.

Effect of depth and duration of cooling on deaths in the NICU among neonates with HIE. Shankaran et al, 2014.