About COOL PRIME

COOL Prime (Comparative Effectiveness for Cooling Prospectively Infants with Mild Encephalopathy) is an observational study that will look at the effects of therapeutic hypothermia (TH) vs normothermia (NT) in infants with mild hypoxic ischemic encephalopathy (HIE). The choice of therapy will be based on each clinical site’s existing practice.

430 infants with mild HIE will be enrolled across 15 pediatric hospitals. Seven of the site routinely practice TH, and 8 practice NT. Infants will be followed for two years to assess cognitive and language outcomes using the Bayley Scales of Infant and Toddler Development and parental questionnaires. Early evaluations of sensory modulation along with standardized questionnaires of mother-infant bonding, parenting structure and attachment, mood and stress, allow a meaningful evaluation.