Effect of Erythropoietin on Preterm Brain Injury

NCT02036073 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 490

Last updated 2014-01-14

No results posted yet for this study

Summary

EPO has been safely used for prevent preterm anemia and recent studies have shown the neuroprotective effect. Our hypothesis is that EPO could prevent preterm brain injury. The aims of this study include: to investigate the safety and efficacy of EPO by using 500u/kg higher than the dose of anemia treatment (250u/kg); to evaluate the effect of EPO on neurodevelopment in preterm infants; to detect biological indicators and explore the neuroprotective mechanism of EPO.

Conditions

  • Premature Birth

Interventions

DRUG

recombinant human erythropoietin

rhEPO 500U/kg was injected within 24h after birth, subsequent injection was given each other day fro 2 weeks.

Sponsors & Collaborators

  • Zhengzhou University

    collaborator OTHER
  • Zhengzhou Children's Hospital, China

    lead OTHER

Study Design

Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
72 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2012-06-30
Completion
2013-12-31

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 NCT02036073 on ClinicalTrials.gov