RECOMBINANT-HUMAN-ERYTHROPOIETIN IN THE TREATMENT OF THE ANEMIA OF PREMATURITY - RESULTS OF A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Objective. To assess the efficacy of recombinant human erythropoietin (rHuEpo) in the treatment of the anemia of prematurity. Methodology. A double-blind, placebo-controlled study was conducted on 80 preterm in fants (less than or equal to 32 weeks; postnatal age, 2 to 8 weeks; ce ntral hematocrit (less than or equal to 35%). Patients were randomly a ssigned to receive subcutaneous rHuEpo (Eprex, 600 U/kg per week) or a n equivalent volume of placebo, for up to 6 weeks. All patients receiv ed supplements of vitamin E (25 TU) and iron (3 mg/kg per day). The ir on supplement was increased if declining serum ferritin measurements w ere noted. Results. Treatment and placebo groups did not differ signif icantly with respect to mean gestational age, birth weight, hematocrit , or reticulocyte count at study entry. Fewer transfusions were admini stered to those receiving erythropoietin (7 compared with 21; P = .002 ). Compared with the placebo group, the infants receiving rHuEpo had a higher mean hematocrit (32.3 +/- 4% vs 29.3 +/- 6.2%; P = .014) and a bsolute reticulocyte count (223 +/- 73 vs 124.9 +/- 73 x 10(9)/L; P < .001) at the end of the study. The mean neutrophil count was not signi ficantly reduced at study exit (P = .8), nor at any other period durin g the trial in the rHuEpo group. Intercurrent events (mostly infection s) were not increased in the treatment group, although there was one c ase of sudden infant death syndrome at age 4 months. Conclusions. Usin g a dose of rHuEpo of 600 U/kg per week, this study has shown a clear reduction in the requirement for blood transfusion in preterm infants.