title: Erythropoietin monotherapy in perinatal asphyxia with moderate to severe encephalopathy: a randomized placebo-controlled trial.
abstract: 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.
  
  
  
  Hundred term neonates with moderate or severe HIE were randomized by random permuted block algorithm to receive either EPO 500 U kg-1per 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).
  
  
  
  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.
  
  
  
  EPO monotherapy reduces the risk of death or disability in term neonates with moderate or severe encephalopathy.
authors.affiliation: Department of Paediatrics, Sheri Kashmir Institute of Medical Sciences, Srinagar, India.
authors.forename: R R
authors.initials: RR
authors.lastname: Malla
authors.affiliation: Department of Neurology, Sheri Kashmir Institute of Medical Sciences, Srinagar, India.
authors.forename: R
authors.initials: R
authors.lastname: Asimi
authors.affiliation: Department of Paediatrics, Sheri Kashmir Institute of Medical Sciences, Srinagar, India.
authors.forename: M A
authors.initials: MA
authors.lastname: Teli
authors.affiliation: Department of Radiodiagnosis and Imaging, Sheri Kashmir Institute of Medical Sciences, Srinagar, India.
authors.forename: F
authors.initials: F
authors.lastname: Shaheen
authors.affiliation: Department of Paediatrics, Sheri Kashmir Institute of Medical Sciences, Srinagar, India.
authors.forename: M A
authors.initials: MA
authors.lastname: Bhat
mesh_terms: D001238:Asphyxia Neonatorum / Q000188:drug therapy* / Q000401:mortality*; D001921:Brain / Q000000981:diagnostic imaging*; D002547:Cerebral Palsy / Q000453:epidemiology; D004311:Double-Blind Method; D004921:Erythropoietin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D020925:Hypoxia-Ischemia, Brain / Q000150:complications*; D007194:India; D007223:Infant; D007231:Infant, Newborn; D008137:Longitudinal Studies; D008279:Magnetic Resonance Imaging; D008297:Male; D011446:Prospective Studies; D012720:Severity of Illness Index; D047929:Term Birth
chemical_list: D004921:Erythropoietin