Erythropoietin improved neurologic outcomes in newborns with hypoxic-ischemic encephalopathy.

Abstract

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.

• Authors: Changlian Zhu, Wenqing Kang, Falin Xu, Xiuyong Cheng, Zhan Zhang, Liting Jia, Ling Ji, Xiaoyan Guo, Hong Xiong, George Simbruner, Klas Blomgren, Xiaoyang Wang
• Journal: Pediatrics (Pediatrics) Vol. 124 Issue 2 Pg. e218-26 (Aug 2009) ISSN: 1098-4275 [Electronic] United States
• PMID: 19651565 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Recombinant Proteins
• Erythropoietin

Topics

• Asphyxia Neonatorum (diagnosis, drug therapy)
• Brain Damage, Chronic (diagnosis, prevention & control)
• China
• Developmental Disabilities (diagnosis, prevention & control)
• Disability Evaluation
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Erythropoietin (administration & dosage, adverse effects)
• Female
• Follow-Up Studies
• Humans
• Hypoxia-Ischemia, Brain (diagnosis, drug therapy)
• Infant
• Infant, Newborn
• Infusions, Intravenous
• Injections, Subcutaneous
• Intensive Care Units, Neonatal
• Male
• Neurologic Examination (drug effects)
• Prospective Studies
• Psychomotor Disorders (diagnosis, prevention & control)
• Recombinant Proteins