Systemic hypothermia induced within 10 hours after birth improved neurological outcome in newborns with...

To evaluate the efficacy of systemic hypothermia when applied within 10 hours after birth to neonates with hypoxic-ischemic encephalopathy (HIE).

Ninety-three term infants with moderate-to-severe HIE were randomly assigned to either systemic hypothermia (n = 46) or conventional treatment (n = 47). Hypothermia was induced within 10 hours after birth, decreasing rectal temperature to 33.5°C for 72 hours, followed by slow rewarming to 36.5°C. Neurodevelopmental outcome was assessed at 18 months old. The primary outcome was death or moderate-to-severe disability.

Outcome data were available for 82 infants. Death or moderate-to-severe disability occurred in 21 of 44 infants (47.7%) in the control group and in 7 of 38 infants (18.4%) in the hypothermia group (P = 0.01) at 18 months. The primary outcome was not different whether hypothermia was started within 6 hours or 6 to 10 hours after birth. Subgroup analysis suggested that systemic hypothermia improved long-term outcome only in infants with moderate HIE (P = 0.009), but not in those with severe HIE. No severe hypothermia-related adverse events were observed.

Systemic hypothermia reduced the risk of disability in infants with moderate HIE, in accordance with earlier studies. Hypothermia was induced within 6 hours in most infants, but delaying the onset to 6 to 10 hours after birth did not negatively affect primary outcome. Further studies with a large number of patients are needed to confirm that delayed cooling is equally effective.