Therapeutic Hypothermia in Hypoxic-Ischemic Encephalopathy
Marianna Parker
Sara V. Bates
Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy
Shankaran S, Laptook AR, Ehrenkranz RA, et al. N Engl J Med. 2005;353(15):1574–1584
Background
Neonatal brain injury caused by hypoxic-ischemic encephalopathy (HIE) affects 0.6% of all births.1 30% of infants surviving with moderate encephalopathy have significant neurologic disability and those with severe encephalopathy have even greater morbidity. Animal models had suggested that therapeutic hypothermia reduced the extent of brain injury after ischemic insult; this study sought to assess its benefits in neonates.
Objectives
To compare effects of therapeutic hypothermia vs. supportive care on mortality and disability in neonates with HIE.
Methods
Prospective, randomized controlled trial at 15 US centers from 2000 to 2003.
Patients
208 neonates born at ≥36 weeks’ gestation admitted to the neonatal intensive care unit (NICU) at ≤6 hours of age, with severe acidosis or complications requiring resuscitation at birth, and moderate or severe encephalopathy or seizures. Select exclusion criteria: major congenital anomalies, birth weight ≤1,800 g, and newborns for whom care was redirected.
Intervention
Infants in the treatment arm underwent whole-body cooling to an esophageal temperature of 33.5°C for 72 hours, followed by slow rewarming. Control group received usual intensive care. Neurologic and developmental testing was performed at 18 to 22 months of age.