CoolCap Trial, Treatment of Perinatal Hypoxic-Ischemic Encephalopathy

Inclusion Criteria: Infants are assessed sequentially by criteria A, B and C listed below. Infant must meet all three criteria to be eligible for trial enrollment. * Criteria A: Infants \>= 36 weeks gestation admitted to the NICU with ONE of the following: * Apgar score of \<= 5 at 10 minutes after birth; * Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth; * Acidosis defined as either umbilical cord pH or any arterial pH within 60 minutes of birth \< 7.00; or * Base Deficit \<= -16 mmol/L in umbilical cord blood sample OR any blood sample within 60 minutes of birth (arterial or venous blood). * Criteria B: Moderate to severe encephalopathy consisting of altered state of consciousness (as shown by lethargy, stupor, or coma) AND at least one or more of the following: * Hypotonia; * Abnormal reflexes, including oculomotor or pupillary abnormalities; * An absent or weak suck; * Clinical seizures * Criteria C: At least 20 minutes duration of amplitude integrated EEG (aEEG/CFM) recording that shows abnormal background aEEG/CFM activity or seizures. The aEEG/CFM is to be performed from one hour of age. If subsequently an abnormal aEEG/CFM is recorded before 5.5 hours of age, the infant is then eligible for enrollment. The aEEG is not to be performed within 30 minutes of IV anticonvulsant therapy as this may cause suppression of EEG activity. In particular, high dose prophylactic anticonvulsant therapy (e.g., …