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Neurological Outcome After Erythropoietin Treatment for Neonatal Encephalopathy

NCT00808704 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2008-12-16

No results posted yet for this study

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.

Conditions

  • Hypoxic-Ischemic Encephalopathy

Interventions

DRUG

recombinant human erythropoietin

r-hu-EPO were administered either 300 U/kg or 500 U/kg, subcutaneously the first time and then intravenously every other day for 2 weeks.

Sponsors & Collaborators

  • Zhengzhou Children's Hospital, China

    collaborator OTHER

  • Medical University Innsbruck

    collaborator OTHER

  • Göteborg University

    collaborator OTHER

  • Zhengzhou University

    lead OTHER

Principal Investigators

  • Changlian Zhu, MD, PhD · Zhengzhou University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00808704 on ClinicalTrials.gov