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For newborns undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy, erythropoietin administration does not yield a lower risk for death or neurodevelopmental impairment than placebo, according to a study published in the July 14 issue of the New England Journal of Medicine.

Yvonne W. Wu, M.D., lotensin and benazepril M.P.H., from the University of California in San Francisco, and colleagues conducted a multicenter, double-blind, randomized trial involving 501 infants born at 36 weeks of gestation or more with moderate or severe hypoxic-ischemic encephalopathy. Participants were randomly assigned to receive erythropoietin or placebo, administered within 26 hours after birth and at 2, 3, 4, and 7 days of age, combined with standard therapeutic hypothermia. The modified intention-to-treat analysis included 500 infants: 257 and 243 received erythropoietin and placebo, respectively.

The researchers found that the incidence of death or neurodevelopmental impairment was 52.5 and 49.5 percent in the erythropoietin and placebo groups, respectively (relative risk, 1.03; 95 percent confidence interval, 0.86 to 1.24; P = 0.74). The erythropoietin group had a higher mean number of serious adverse events per child compared with the placebo group (0.86 versus 0.67; relative risk, 1.26; 95 percent confidence interval, 1.01 to 1.57).

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