THE EFFECT OF ERYTHROPOIETIN ON THE TRANSFUSION REQUIREMENTS OF PRETERM INFANTS WEIGHING 750 GRAMS OR LESS - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Background: Clinical trials of erythropoietin (EPO) administration to preterm infants have not focused on infants weighing 750 gm or less, t he population most likely to receive multiple transfusions because of large phlebotomy losses. It is unknown whether preterm infants weighin g 750 gm or less will respond to EPO by accelerating erythropoiesis, o r whether EPO administered to this population will decrease blood tran sfusions. Methods: We randomly assigned 28 extremely low birth weight preterm infants (mean +/- SEM: 24.7 +/- 0.3 weeks' gestation, 662 +/- 14 gm birth weight), in the first 72 hours of life, to receive either EPO (200 U/kg/day) or placebo for 14 days and administered transfusion s only according to protocol over a 21-day study period. All infants r eceived 1 mg/kg/day iron dextran in their total parenteral nutrition s olution during the 14-day treatment period. Results: During the 21-day study period, a lower number and volume of transfusions were received by the EPO recipients (4.7 +/- 0.7 transfusions per patient and 70 +/ - 11 ml/kg per patient) than by the placebo recipients (7.5 +/- 1.1 tr ansfusions per patient and 112 +/- 17 ml/kg per patient; p < 0.05, EPO vs placebo), whereas hematocrits remained similar in the two groups. Reticulocyte counts were similar in both groups on day 1 but were grea ter in the EPO recipients on day 14 (EPO day 1,351 +/- 53; EPO day 14, 359 +/- 40 x 10(3)/mu l; placebo day 1,334 +/- 64; placebo day 14, 12 0 +/- 10 x 10(3)/mu l; p < 0.01, EPO vs placebo). Serum ferritin conce ntrations were similar in both groups at the beginning of the study bu t were greater in the placebo recipients by day 14 (EPO, 262 +/- 44 mu g/L; placebo, 593 +/- 92 mu g/L; p < 0.01). No adverse effects of EPO or iron were noted. Conclusion: The combination of EPO and parenteral iron stimulates erythropoiesis in preterm infants weighing 750 gm or less and results in fewer transfusions during their first 3 weeks of l ife.