Optimizing Cooling Strategies at <6 Hours of Age for Neonatal Hypoxic-Ischemic Encephalopathy

The Optimizing Cooling trial compared four whole-body cooling treatments for infants born at 36 weeks gestational age or later with hypoxic-ischemic encephalopathy: (1) cooling for 72 hours to 33.5�C; (2) cooling for 120 hours to 33.5�C; (3) cooling for 72 hours to 32.0�C; and (4) cooling for 120 hours to 32.0�C. The objective of this study was to evaluate whether whole-body cooling initiated at less than 6 hours of age and continued for 120 hours and/or a depth at 32.0�C would reduce death and disability at 18-22 months corrected age. This trial was terminated early for emerging safety profiles and futility reasons. Longer duration of cooling was associated with more arrhythmia and anuria and longer hospital days, whereas deeper cooling was associated with higher use of inhaled nitric oxide therapy, ECMO, more days of oxygen, and higher incidence of bradycardia.