Erythropoietin for the Repair of Cerebral Injury in Very Preterm Infants

• Status: Active, not recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this randomized and placebo-controlled EpoRepair trial is to evaluate the effect of intravenously administered recombinant human erythropoietin (Epo) as compared to placebo in preterm infants with brain damage on neurological development until five years od age.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Collaborator: Swiss National Science Foundation
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

1. Infants with less than 32 weeks of gestation and/or less than 1500 g weight at birth

2. Intraventricular hemorrhage and/or hemorrhagic parenchymal infarction

3. Less than 8 days of life

4. Informed written parental consent

Exclusion Criteria:

1. Genetically defined syndrome

2. Severe congenital malformation adversely affecting life expectancy and/or neurodevelopment

3. A priory palliative care

4. Unlikely to participate at 5-year follow-up examination