Erythropoietin monotherapy in perinatal asphyxia with moderate to severe encephalopathy: a randomized placebo-controlled trial

Objective:erythropoietin (epo) is neuroprotective after asphyxia in animal studies. the efficacy and safety of epo monotherapy in term neonates with hypoxic ischemic encephalopathy (hie) is uncertain.study design:hundred term neonates with moderate or severe hie were randomized by random permuted block algorithm to receive either epo 500 u kg−1 per dose in 2 ml saline intravenously (50 neonates) on alternate days for a total of five doses with the first dose given by 6 h of age (treatment group) or 2 ml of normal saline (50 neonates) similarly for a total of five doses (placebo group) in a double-blind study. no hypothermia was given. the primary outcome was combined end point of death or moderate or severe disability at mean age of 19 months (s.d., 0.61).results:death or moderate or severe disability occurred in 40% of neonates in the treatment group vs 70% in the placebo group (risk ratio, 0.57; 95% confidence interval (ci) 0.38 to 0.85; p=0.003). death occurred in 16% of patients in both the groups (risk ratio, 1.0; 95% ci 0.33 to 2.9; p=0.61). the risk of cerebral palsy was lower among survivors in the treatment group (risk ratio, 0.52; 95% ci 0.25 to 1.03; p=0.04) and lesser number of babies were on anticonvulsants at assessment (risk ratio, 0.47; 95% ci 0.20 to 1.01; p=0.03). neonatal brain magnetic resonance imaging showed more abnormalities in the placebo group (relative risk, 0.66; 95% ci 0.42 to 1.03; p=0.04)). improvement in other neurological outcomes was not significant.conclusion:epo monotherapy reduces the risk of death or disability in term neonates with moderate or severe encephalopathy.