title: A randomized, masked, placebo-controlled study of darbepoetin alfa in preterm infants.
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.
authors.affiliation: Department of Pediatrics, University of New Mexico, Albuquerque, NM, USA. rohls@salud.unm.edu
authors.forename: Robin K
authors.initials: RK
authors.lastname: Ohls
authors.forename: Robert D
authors.initials: RD
authors.lastname: Christensen
authors.forename: Beena D
authors.initials: BD
authors.lastname: Kamath-Rayne
authors.forename: Adam
authors.initials: A
authors.lastname: Rosenberg
authors.forename: Susan E
authors.initials: SE
authors.lastname: Wiedmeier
authors.forename: Mahshid
authors.initials: M
authors.lastname: Roohi
authors.forename: Conra Backstrom
authors.initials: CB
authors.lastname: Lacy
authors.forename: Diane K
authors.initials: DK
authors.lastname: Lambert
authors.forename: Jill J
authors.initials: JJ
authors.lastname: Burnett
authors.forename: Barbara
authors.initials: B
authors.lastname: Pruckler
authors.forename: Ron
authors.initials: R
authors.lastname: Schrader
authors.forename: Jean R
authors.initials: JR
authors.lastname: Lowe
mesh_terms: D000751:Anemia, Neonatal / Q000097:blood / Q000188:drug therapy*; D000068256:Darbepoetin alfa; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D017707:Erythrocyte Transfusion; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D019983:Guideline Adherence; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D052577:Infant, Extremely Low Birth Weight; D007231:Infant, Newborn; D007235:Infant, Premature, Diseases / Q000097:blood / Q000188:drug therapy*; D019102:Infant, Very Low Birth Weight; D007279:Injections, Subcutaneous; D008297:Male; D017701:Reticulocyte Count; D013810:Therapeutic Equivalency
chemical_list: D006397:Hematinics; D004921:Erythropoietin; D000068256:Darbepoetin alfa
keywords: anemia; erythropoietin; prematurity; transfusions