Mild Encephalopathy in the Newborn Treated With Darbepoetin
Status:
Recruiting
Trial end date:
2021-10-31
Target enrollment:
Participant gender:
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 8-12 months of age. Pharmacokinetics will be assessed on those infants that received
Darbe.