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

Autor: DuPont, Tara L., Baserga, Mariana, Lowe, Jean, Zamora, Tara, Beauman, Sandra, Ohls, Robin K.
Zdroj: Journal of Perinatology; 20240101, Issue: Preprints p1-8, 8p
Abstrakt: 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.
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