Clinical Trial: Mild Encephalopathy in the Newborn Treated With Darbepoetin

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional




Official Title: Mild Encephalopathy in the Newborn Treated With Darbepoetin (MEND)

Brief Summary: This is a Phase II multicenter placebo-controlled randomized, feasibility/safety trial. Infants >34 week gestational age with perinatal acidemia and mild neonatal encephalopathy on the modified Sarnat neurologic examination at less than six hours of age. Participants will be randomized to receive either one dose of Darbepoetin, or placebo within 24 hours of birth. Neurodevelopmental testing (Bayley III and Gross Motor Function Assessment) will be performed at 12-18 months of age.