Darbepoetin administration to neonates undergoing cooling for encephalopathy: a safety and pharmacokinetic trial.

ABSTRACT:

Background

Despite therapeutic hypothermia, neonates with encephalopathy (NE) have high rates of death or disability. Darbepoetin alfa (Darbe) has comparable biological activity to erythropoietin, but has extended circulating half-life (t(1/2)). Our aim was to determine Darbe safety and pharmacokinetics as adjunctive therapy to hypothermia.

Study design

Thirty infants (n = 10/arm) ≥36 wk gestation undergoing therapeutic hypothermia for NE were randomized to receive placebo, Darbe low dose (2 μg/kg), or high dose (10 μg/kg) given intravenously within 12 h of birth (first dose/hypothermia condition) and at 7 d (second dose/normothermia condition). Adverse events were documented for 1 mo. Serum samples were obtained to characterize Darbe pharmacokinetics.

Results

Adverse

SUBMITTER: Baserga MC 

PROVIDER: S-EPMC5564328 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature