Effect of Early Versus Late Administration of Human Recombinant Erythropoietin on Transfusion Requirements in Premature Infants: Results of a Randomized, Placebo-Controlled, Multicenter Trial

Abstract

In the whole population, the early administration of rHuEPO induced a rise of reticulocyte counts, but not enough to reduce the transfusion requirement. The most severely ill infants (BW <800 g and phlebotomy losses >30 mL/kg) seemed to benefit from early use of rHuEPO, and this deserves additional study.

Effect of Beginning Recombinant Erythropoietin Treatment Within the First Week of Life, Among Very-Low-Birth-Weight Neonates, on “Early” and “Late” Erythrocyte Transfusions: A Meta-Analysis

“…General characteristics of the 12 acceptable, relevant, studies [6][7][8][9][10][11][12][13][14][15][16][17] are given in Table 1, listed in chronological order of publication. The 12 studies involved a total of 1090 VLBW neonates; 561 rEpo and 529 placebo recipients.…”

“…The weekly rEpo dose ranged from 90 6 to 1400 U/kg/week. 10,12 Studies published before 1995 all used a subcutaneous route of rEpo administration; 6-8, 15,16 afterward, the route was intravenous in some [9][10][11]13,14,17 and subcutaneous in others. 12,14,17 The route of administration of iron was enteral at 2 to 6 mg/kg/day, with three exceptions; Ohls et al 11 included iron dextran (1 mg/kg/day) in the hyperalimentation solution as a continuous administration in one study and intravenous iron at 5 mg/kg/week followed by enteral administration at 6 mg/kg/day in another trial.…”

“…The data regarding ''late'' transfusions could be analyzed for nine studies [6][7][8][12][13][14][15][16][17] (Q ¼ 10.81, p ¼ 0.289). The OR for receiving a ''late'' transfusion if rEpo was begun in the first week of life was 0.56 (95% CI: 0.37 to 0.83, p ¼ 0.036.…”

“…Studies that utilized a randomized, placebo-controlled and double-masked design, where rEpo and placebo treatments were begun in the first week of life, were selected. [6][7][8][9][10][11][12][13][14] Studies that did not include the use of a placebo in their design, but described a procedure to maintain appropriate masking, were also considered eligible. [15][16][17] Studies were included in the meta-analysis if the authors reported at least one of the following outcomes: proportion of neonates transfused, mean number of transfusions per patient, and mean volume of erythrocyte transfusion for both rEpo and control groups.…”

“…Specifically, Dr. Lima 12 was asked to provide data regarding the number of transfusions given to the individual rEpo recipients and placebo recipients during their first three weeks of life, so that the common odds ratios (OR) could be calculated. Dr. Donato 13 was asked to provide data regarding the total number of transfused patients during the first three weeks.…”