Does Erythropoietin Improve Outcome in Very Preterm Infants?

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Neonatal Network
• Collaborator: Swiss National Science Foundation
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Infants born between 26 0/7 and 31 6/7 gestational weeks

• Postnatal age less than 3 hours

• Informed parental consent (preferably obtained before birth)

Exclusion Criteria:

• Genetically defined syndrome

• Severe congenital malformation adversely affecting life expectancy

• Severe congenital malformation adversely affecting neurodevelopment

• A priory palliative care

• Intracranial haemorrhage grade 3 or more detected before dose 3 of Erythropoietin