Enteral erythropoietin increases plasma erythropoietin level in preterm infants: a randomized controlled trial

OBJECTIVE: To evaluate the effects of enteral administration of recombinant human erythropoietin (rhEPO) on serum level of erythropoietin and erythropoiesis in preterm infants. STUDY DESIGN: Randomized controlled trial. SETTING: Level III NICU. SUBJECTS: 16 preterm infants less than 34 wk with birth weight less than 1800 g. INTERVENTION: Enteral rhEPO 400 U/kg, three times/week, plus FeSO4,3-6 mg/Kg/day ( Study group, n = 7) or FeSO4 only (Control group, n = 9). OUTCOME MEASURES: Hemoglobin, serum erythropoietin (EPO), reticulocyte count, and serum ferritin levels, measured at baseline, after 10 days and at discharge. RESULTS: Mean birth weight and gestational age for the Study and the Control groups were 1328.5 +/- 267.4 vs. 1392.8 +/- 196.7 g and 30.7 +/- 2.5 vs. 30.2 +/- 0.9 weeks, respectively. At discharge, there was no difference in hemoglobin or hematocrit but the reticulocyte counts were significantly higher in the Study group (1.4 +/- 0.7 vs. 0.7 +/- 0.4, P = 0.03). Serum erythropoietin level was significantly higher in the Study group (18 +/- 11 vs. 8.6 +/- 3.9 mU/mL, P = 0.006). Conversely, serum ferritin level was lower in the study group but did not achieve statistical significance. CONCLUSIONS: Enteral administration of rhEPO in preterm infants resulted in increase in serum erythropoietin and reticulocyte counts at the time of discharge without significantly affecting hemoglobin or hematocrit.