High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study

• Status: Terminated
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The highest risk for perinatal brain injury occurs among extremely premature infants who weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible, associated with neurodevelopmental disability, and without adequate treatment modalities. Research in recent years suggest in both animal and human studies that erythropoietin (Epo) may have significant neuroprotective effects. Given the historical safe medical profile of Epo when used for anemia of prematurity but the likely need for a greater dosage regimen for activation of neuroprotective pathways against neonatal brain injury, we therefore propose this phase II study of high-dose Epo in very low birth weight infants for the prevention and/or attenuation of prematurity-related cerebral hemorrhagic-ischemic injury.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Atlantic Health System
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• 500 to 1250 grams at birth

• Less than 32 weeks gestation at birth

• Less than 24 hours of life at time of enrollment

Exclusion Criteria:

• Congenital anomalies (chromosomal, CNS, cardiac, GI, pulmonary)

• Seizures within first 24 hours of life

• Severe neutropenia (ANC < 500 cells/microL) within first 24 hours of life

• Polycythemia (Hct > 65%) within first 24 hours of life

• Thrombocytopenia (platelets < 50K cells/microL) within first 24 hours of life

• Hypertension (SBP > 100mmHg) without vasopressor support within first 24 hours of life