Published online July 27, 2009
PEDIATRICS Vol. 124 No. 2 August 2009, pp. e218-e226 (doi:10.1542/peds.2008-3553)

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ARTICLE

Erythropoietin Improved Neurologic Outcomes in Newborns With Hypoxic-Ischemic Encephalopathy

Changlian Zhu, MD, PhD^a,b, Wenqing Kang, MD^c, Falin Xu, MD, PhD^a,b, Xiuyong Cheng, MD^a,b, Zhan Zhang, MD, PhD^b,d, Liting Jia, MD^b,d, Ling Ji, MD^a, Xiaoyan Guo, MD^a, Hong Xiong, MD^c, George Simbruner, MD^e, Klas Blomgren, MD, PhD^f,g and Xiaoyang Wang, MD, PhD^a,b

Departments of ^a Pediatrics
^d Laboratory Medicine, Third Affiliated Hospital of Zhengzhou University, Zhengzhou, China
^b Henan Key Laboratory for Neonatal Brain Injury, Zhengzhou, China
^c Department of Pediatrics, Zhengzhou Children's Hospital, Zhengzhou, China
^e Department of Pediatrics IV Medical University Innsbruck, Innsbruck, Austria
^f Center for Brain Repair and Rehabilitation, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden
^g Department of Pediatric Oncology, Queen Silvia Children's Hospital, Gothenburg, Sweden

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.

CONCLUSION: Repeated, low-dose, recombinant human erythropoietin treatment reduced the risk of disability for infants with moderate HIE, without apparent side effects.

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Key Words: asphyxia • erythropoietin • hypoxic-ischemic encephalopathy • neonates

Abbreviations: HIE—hypoxic-ischemic encephalopathy • BBB—blood-brain barrier • MDI—Mental Developmental Index • CSF—cerebrospinal fluid

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Accepted Mar 17, 2009.

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Erythropoietin treatment in hypoxic-ischemic encephalopathy

Christof Dame, et al.

Pediatrics Online, 19 Oct 2009 [Full text]