Erythropoietin improved neurologic outcomes in newborns with hypoxic-ischemic encephalopathy.
OBJECTIVE
The purpose of this study was to evaluate the efficacy and safety of erythropoietin in neonatal hypoxic-ischemic encephalopathy (HIE), by using a randomized, prospective study design.


METHODS
A total of 167 term infants with moderate/severe HIE were assigned randomly to receive either erythropoietin (N = 83) or conventional treatment (N = 84). Recombinant human erythropoietin, at either 300 U/kg (N = 52) or 500 U/kg (N = 31), was administered every other day for 2 weeks, starting <48 hours after birth. The primary outcome was death or disability. Neurodevelopmental outcomes were assessed at 18 months of age.


RESULTS
Complete outcome data were available for 153 infants. Nine patients dropped out during treatment, and 5 patients were lost to follow-up monitoring. Death or moderate/severe disability occurred for 35 (43.8%) of 80 infants in the control group and 18 (24.6%) of 73 infants in the erythropoietin group (P = .017) at 18 months. The primary outcomes were not different between the 2 erythropoietin doses. Subgroup analyses indicated that erythropoietin improved long-term outcomes only for infants with moderate HIE (P = .001) and not those with severe HIE (P = .227). No negative hematopoietic side effects were observed.


CONCLUSIONS
Repeated, low-dose, recombinant human erythropoietin treatment reduced the risk of disability for infants with moderate HIE, without apparent side effects.
Zhu
Changlian
C
Department of Pediatrics, Third Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China. zhuc@zzu.edu.cn
Kang
Wenqing
W
Xu
Falin
F
Cheng
Xiuyong
X
Zhang
Zhan
Z
Jia
Liting
L
Ji
Ling
L
Guo
Xiaoyan
X
Xiong
Hong
H
Simbruner
George
G
Blomgren
Klas
K
Wang
Xiaoyang
X
D001238:Asphyxia Neonatorum / Q000175:diagnosis / Q000188:drug therapy*; D001925:Brain Damage, Chronic / Q000175:diagnosis / Q000517:prevention & control; D002681:China; D002658:Developmental Disabilities / Q000175:diagnosis / Q000517:prevention & control; D004185:Disability Evaluation; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D020925:Hypoxia-Ischemia, Brain / Q000175:diagnosis / Q000188:drug therapy*; D007223:Infant; D007231:Infant, Newborn; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D007363:Intensive Care Units, Neonatal; D008297:Male; D009460:Neurologic Examination / Q000187:drug effects; D011446:Prospective Studies; D011596:Psychomotor Disorders / Q000175:diagnosis / Q000517:prevention & control; D011994:Recombinant Proteins
D011994:Recombinant Proteins; D004921:Erythropoietin