HF03 in Randomized Controlled Trial of Induced Hypothermia for Hypoxic-Ischemic Encephalopathy in Term Infants

Dataset HF03
Study Description
This large multicenter trial tested whether cerebral cooling initiated within 6 hours of birth and continued for 72 hours would reduce the risk of death and moderate to severe neurodevelopmental injury at 18-22 months corrected age. Infants at least 36 weeks gestation with an abnormal blood gas within 1 hour of birth, or a history of an acute perinatal event and a 10-min Apgar score <5, or continued need for ventilation were screened. Following a neurological exam, those with moderate to severe encephalopathy were randomized to a 72-hour period of total body cooling (cooling blanket, followed by slow re-warming). Infants enrolled in the trial were gestational age of at least 36 weeks who were admitted to the hospital at or before six hours of age who had moderate or severe encephalopathy.