A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF RECOMBINANT ERYTHROPOIETIN IN TREATMENT OF THE ANEMIA OF BRONCHOPULMONARY DYSPLASIA

Because anemia in patients with bronchopulmonary dysplasia is characte rized by inappropriately low serum concentrations of erythropoietin bu t increased in vitro sensitivity of erythroid progenitors to erythropo ietin, we speculated that administration of human recombinant erythrop oietin would correct this anemia. Fifteen infants with the anemia of b ronchopulmonary dysplasia were randomly assigned to receive erythropoi etin or placebo subcutaneously for 10 days. Changes in reticulocyte co unt, hematocrit, blood lactate concentration, neutrophil count, platel et count, heart rate, oxygen requirement, weight gain, and number of t ransfusions were assessed. In the 10 erythropoietin recipients (99 +/- 12 days of age), hematocrit values increased from 0.325 +/- 0.006 to 0.381 +/- 0.013 (mean +/- SEM; p <0.005) and reticulocyte counts from 122 +/- 20 to 446 +/- 48 x 10(3)/mul (p <0.005); lactate values remain ed unchanged. In the five placebo recipients (91 +/- 12 days of age), hematocrits and reticulocyte counts remained unchanged, and lactate va lues increased from 0.73 +/- 0.14 to 1.34 +/- 0.25 mumol/gm (p<0.05). During the 30 days after the treatment period, one erythropoietin reci pient and four placebo recipients were given transfusions. Other measu red variables remained unchanged in both groups. We conclude that eryt hropoietin is effective in treatment of the anemia of bronchopulmonary dysplasia.