At a glance
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Mild Encephalopathy in the Newborn Treated With Darbepoetin (MEND)
In Brief
A Phase 2 clinical trial evaluating Darbepoetin Alfa and Normal Saline for Neonatal Encephalopathy and Hypoxic-Ischemic Encephalopathy Mild. Completed, enrolled 28 participants across 1 site.
Detailed 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 or IV) and Gross Motor Function Assessment) will be performed at 24 months of age. Pharmacokinetics will be assessed on those infants that received Darbe.
Study Details
Timeline
Interventions
Single dose of 10 mcg/kg Darbepoetin Alpha given IV at less than 24 hours of age
Single dose of normal saline, IV, given at less than 24 hours of age