drugset / Trial / NCT00808704
Neurological Outcome After Erythropoietin Treatment for Neonatal Encephalopathy
Phase 1/2
Completed
167 enrolled
Zhengzhou University
Göteborg University · collabMedical University Innsbruck · collabZhengzhou Children's Hospital, China · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and mortality in term and preterm neonates, accounting for 23% of neonatal deaths globally. Although many neuroprotective strategies appeared promising in animal models, most of them have failed clinically. Erythropoietin (EPO) is an endogenous cytokine originally identified for its role in erythropoiesis. Clinical trial has demonstrated the safety and efficacy of recombinant human erythropoietin (r-hu-EPO) in the prevention or treatment of anemia of prematurity. To date, there are no reports evaluating possible effects of EPO on neonatal HIE.
Timeline
- Start
- 2003-08
- Primary completion
- 2008-07
- Completion
- 2008-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | epoetin alfa | Protein / enzyme biologic | 300 iu/kg | Subcutaneous |
| Subject | epoetin alfa | Protein / enzyme biologic | 500 iu/kg | Subcutaneous |