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Randomized Controlled Trial Multicenter Study
Erythropoietin improved neurologic outcomes in newborns with hypoxic-ischemic encephalopathy.
- Changlian Zhu, Wenqing Kang, Falin Xu, Xiuyong Cheng, Zhan Zhang, Liting Jia, Ling Ji, Xiaoyan Guo, Hong Xiong, George Simbruner, Klas Blomgren, and Xiaoyang Wang.
- Department of Pediatrics, Third Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China. zhuc@zzu.edu.cn
- Pediatrics. 2009 Aug 1; 124 (2): e218-26.
ObjectiveThe 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.MethodsA 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.ResultsComplete 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.ConclusionRepeated, low-dose, recombinant human erythropoietin treatment reduced the risk of disability for infants with moderate HIE, without apparent side effects.
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