Darbepoetin as a neuroprotective agent in mild neonatal encephalopathy: a randomized, placebo-controlled, feasibility trial.

ABSTRACT

OBJECTIVE: To assess the feasibility and safety of one dose of Darbepoetin alpha (Darbe) administered to neonates ≥34 weeks with mild neonatal encephalopathy (NE). METHODS: Randomized, masked, placebo-controlled study including neonates ≥34 weeks gestation with mild NE. Neonates were randomized to receive one dose of Darbe (10 µg/kg IV) or placebo. Clinical and laboratory maternal and newborn data were collected. The Bayley Scales of Infant and Toddler Development, third edition (Bayley-III) and a standardized neurological examination at 8-12 months of corrected age were assessed. RESULTS: There were no differences in baseline characteristics of the 21 infants randomized (9 Darbe, 12 placebo). Adverse events were not reported at any time. Bayley-III scores were average in both Darbe and placebo groups. CONCLUSION: This study demonstrates that a randomized, masked, placebo-controlled trial is safe and feasible. A large, randomized trial is warranted to assess the effect of Darbe in this population.