Erythropoietin treatment does not provide neuroprotection to preterm infants: NEJM

USA: The administration of high-dose erythropoietin treatment to extremely preterm infants from 24 hours after birth through 32 weeks of postmenstrual age did not lower the risk of severe neurodevelopmental impairment or death at 2 years of age, according to a recent study published in the New England Journal of Medicine. 

In preclinical models of neonatal brain injury, high-dose erythropoietin has been shown to have a neuroprotective effect. Phase 2 trials have suggested possible efficacy. However, the safety and benefits of this therapy has not been established in extremely preterm infants. 

Sandra E. Juul, Department of Pediatrics, Division of Neonatology, University of Washington, Seattle, WA, and colleagues determined the safety and benefits of high-dose erythropoietin in extremely preterm infants in this multicenter, randomized, double-blind trial of high-dose erythropoietin. 

For the purpose, the researchers assigned 941 infants who were born at 24 weeks 0 days to 27 weeks 6 days of gestation to receive erythropoietin or placebo within 24 hours after birth. Erythropoietin was administered intravenously at a dose of 1000 U per kilogram of body weight every 48 hours for a total of six doses, followed by a maintenance dose of 400 U per kilogram three times per week by subcutaneous injection through 32 completed weeks of postmenstrual age. Placebo was administered as intravenous saline followed by sham injections.