Clinical trials of erythropoietin (Epo) administration to preterm infants have for the most part excluded infants ≤750 grams, the population most likely to receive multiple transfusions due to large phlebotomy losses. It is unknown whether extremely low birth weight (ELBW) infants will respond to Epo by accelerating erythropoiesis, or whether Epo administered to this population will decrease blood transfusions. We randomized 20 ELBW infants(24.7±0.3 weeks gestation, 662±14 grams birth weight; mean±SEM) in the first 72 hours of life to receive either Epo (200 units/kg/day) or placebo for 14 days, and administered transfusions only according to protocol over a 21 day study period. All infants received 1 mg/kg/day iron dextran in their TPN solution for 14 days. During the 21 day study period, fewer transfusions were received by the Epo recipients(5.7±1.0 per patient) than by the placebo recipients (9.8±1.0 per patient, p<0.05), while hematocrits were similar in the two groups throughout the study (Epo day 1: 32.6±1.6%, day 14: 35.2±1.9%, day 21: 32.6±1.6%; placebo day 1: 33.8±1.6%, day 14: 33.5±1.5%, day 21: 31.4±2.2%). Reticulocyte counts were similar in both groups on day 1, but were greater in the Epo recipients than in the placebo recipients on days 14 and 21 (Epo day 1: 329±65, day 14: 366±29, day 21: 258±51 ×103/μL; placebo day 1: 257±27, day 14: 117±9, day 21: 114±42×103/μL; p<0.01, Epo day 14 versus placebo day 14; p=0.06, Epo day 21 versus placebo day 21). Serum ferritin concentrations did not change from day 1 to day 14 in the Epo recipients (day 1:198±35, day 14: 254±53 ng/mL), but increased in the placebo recipients (day 1: 111±21, day 14: 608±117 ng/mL, p<0.05, day 14 versus day 1, and day 14 versus Epo day 14). No adverse effects of Epo or iron were noted. We conclude that the combination of Epo and iron administration stimulates erythropoiesis in ELBW infants, and results in fewer transfusions during their first three weeks of life.
