HIGH DOSE ERYTHROPOIETIN FOR ASPHYXIA AND ENCEPHALOPATHY (HEAL)

HIGH DOSE ERYTHROPOIETIN FOR ASPHYXIA AND ENCEPHALOPATHY A randomized, placebo-­controlled, double-­masked 500 -­ subject clinical trial of erythropoietin for the treatment of neonatal hypoxic-­ischemic encephalopathy (HIE)
1) To determine if 5 doses of Epo 1000 U/kg (birth weight) intravenous (IV) reduces the rate of death or neurodevelopmental impairment (mild, moderate, or severe) at 24 months of age. 2) To assess safety of Epo. 3) To determine whether Epo decreases the severity of HIE-induced brain injury as evidenced by early MRI and plasma biomarkers of brain injury.
CHLA IRB Number
CHLA-16-00535
Study Type
Randomized
Eligibility
1. Newborns ≥ 36 weeks gestational age 2. Receiving active or passive whole body cooling/hypothermia since < 6 hours of age 3. 2.Perinatal depression. 3. Moderate to severe encephalopathy.
Enrollment Status
Open
Does this study also recruit healthy volunteers?
No
Coordinator Contact
Sharon Tang
Contact Email
shatang@chla.usc.edu