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:
Participant gender:
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.