Darbepoetin improves erythropoietic response but not cognitive outcomes in preterm infants

Administering darbepoetin infusions to preterm infants does not appear to help with cognitive outcomes, although it increases hematocrit values and reduces blood transfusions and donor exposures, according to a study.

The study included 650 infants between 23 0/7 and 28 6/7 weeks of gestation (mean gestational age 26.2 weeks, 50.5 percent female) who were admitted to neonatal intensive care units. By 36 h after birth, the infants had been randomized to receive weekly placebo (n=328) or darbepoetin (10 μg/kg; n=322) infusions through 35 weeks’ postmenstrual age.

The primary outcome was the mean cognitive composite score on the Bayley Scales of Infant Development, third edition (Bayley-III) at 22 to 26 months’ corrected age. Infants who died were assigned the lowest possible score (54).

Of the infants, 583 were included in the analysis (291 in the darbepoetin group and 292 in the placebo group). Mean cognitive scores at 22 to 26 months’ corrected age did not significantly differ between the darbepoetin and placebo groups (80.7 vs 80.1; adjusted mean difference, −0.23, 95 percent confidence interval [CI], −3.09 to 2.64).

In terms of erythropoietic responses, more infants in the darbepoetin group than in the placebo group were transfusion-free (40 percent vs 21 percent; adjusted relative risk [RR], 1.3, 95 percent CI, 1.2–1.5), received fewer transfusions (mean, 2.3 vs 3.3), and were exposed to fewer donors (mean, 1.6 vs 2.2). The darbepoetin group also had higher red cell mass (adjusted mean difference, 3.2, 95 percent CI, 1.7–4.7) and higher mean hematocrit (adjusted mean difference, 2.8, 95 percent CI, 2.1–3.6) by week 2 of age, in addition to being less likely to have bronchopulmonary dysplasia grade >1 (35 percent vs 46 percent; relative risk, 0.78, 95 percent CI, 0.64–0.96).

No significant between-group differences were observed in the incidence of retinopathy of prematurity stage >2 (13 percent in the darbepoetin group vs 16 percent in the placebo group) and adverse effects.