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Does Erythropoietin Improve Outcome in Very Preterm Infants?

NCT00413946 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2018-10-30

No results posted yet for this study

Summary

The main goal of this trial is to investigate whether early administration of human erythropoietin (EPO) in very preterm infants improves neurodevelopmental outcome at 24 months corrected age.

This study is designed as randomized, double-masked, placebo controlled multicenter study involving at least 420 patients.

Conditions

  • Intracranial Hemorrhage
  • Periventricular Leukomalacia
  • Cerebral Palsy
  • Developmental Psychomotor Disorders

Interventions

DRUG

Recombinant human Erythropoietin

3 doses 3000 units (1 ml) of recombinant human erythropoietin per kg body weight

DRUG

saline

three doses of 1.0 ml saline per body weight

Sponsors & Collaborators

  • Swiss National Science Foundation

    collaborator OTHER

  • Swiss Neonatal Network

    lead NETWORK

Principal Investigators

  • Hans U Bucher, Prof · University of Zurich

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
3 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Switzerland

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 NCT00413946 on ClinicalTrials.gov