Worldwide Reports

A Randomized, Masked, Placebo-Controlled Study of Darbepoetin Alfa in Preterm Infants

Ohls RK | Pediatrics. |
Clinical Translational Research Center, University of New Mexico
Albuquerque, NM, USA

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Abstract
BACKGROUND

A novel erythropoiesis stimulating agent (ESA), darbepoetin alfa (Darbe), increases hematocrit in anemic adults when administered every 1 to 3 weeks. Weekly Darbe dosing has not been evaluated in preterm infants. We hypothesized that infants would respond to Darbe by decreasing transfusion needs compared with placebo, with less-frequent dosing than erythropoietin (Epo).

METHODS

Preterm infants 500 to 1250 g birth weight and ≤48 hours of age were randomized to Darbe (10 μg/kg, 1 time per week subcutaneously), Epo (400 U/kg, 3 times per week subcutaneously) or placebo (sham dosing) through 35 weeks’ gestation. All received supplemental iron, folate, and vitamin E, and were transfused according to protocol. Transfusions (primary outcome), complete blood counts, absolute reticulocyte counts (ARCs), phlebotomy losses, and adverse events were recorded.

RESULTS

A total of 102 infants (946 ± 196 g, 27.7 ± 1.8 weeks’ gestation, 51 ± 25 hours of age at first dose) were enrolled. Infants in the Darbe and Epo groups received significantly fewer transfusions (P = .015) and were exposed to fewer donors (P = .044) than the placebo group (Darbe: 1.2 ± 2.4 transfusions and 0.7 ± 1.2 donors per infant; Epo: 1.2 ± 1.6 transfusions and 0.8 ± 1.0 donors per infant; placebo: 2.4 ± 2.9 transfusions and 1.2 ± 1.3 donors per infant). Hematocrit and ARC were higher in the Darbe and Epo groups compared with placebo (P = .001, Darbe and Epo versus placebo for both hematocrit and ARCs). Morbidities were similar among groups, including the incidence of retinopathy of prematurity.

CONCLUSIONS

Infants receiving Darbe or Epo received fewer transfusions and fewer donor exposures, and fewer injections were given to Darbe recipients. Darbepoetin and Epo successfully serve as adjuncts to transfusions in maintaining red cell mass in preterm infants.

Pediatrics comments

What’s Known on This Subject

Preterm infants in the NICU receive the greatest number of transfusions of any patient population. The administration of the long-acting erythropoiesis stimulating agent (ESA) darbepoetin to reduce or eliminate transfusions in preterm infants has not been evaluated.

What This Study Adds 

Infants receiving ESAs received half the number of transfusions and were exposed to approximately half the donors compared with the placebo group. More than half of the ESA recipients (59% darbepoetin recipients, 52% erythropoietin recipients) remained untransfused during their hospitalization.

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