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

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 mu g/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.

Automated summary

This study shows that conducting a randomized, masked, placebo-controlled trial in neonates with mild neonatal encephalopathy is safe and feasible. There were no adverse events reported, and both Darbe and placebo groups had average Bayley-III scores. Further research is needed to assess the effect of Darbe in this population.