Randomized controlled trial of early (EI) versus late (LI) enteral iron supplementation in infants with a birth weight < 1300g not receiving erythropoietin under a restrictive red cell transfusion (RCT) protocol

Abstract 150

Objective: To evaluate whether EI would improve iron status at day 61. Methods: 181 infants were randomized at day 7 to receive either 2mg/kg/day ferrous sulfate as soon as enteral feedings of >100ml/kg/day were tolerated (EI) or to receive supplemental iron from 61 days of life (LI). Infants received human milk or iron fortified preterm cow milk formula (12mg/l). A restrictive RCT protocol was followed that allows hematocrits down to 21% in asymptomatic infants. Primary outcome criteria: mean ferritin at 61 days and presence of iron deficiency (ID) defined as ferritin (Fer) ≤10ng/ml or transferrin saturation ≤16% or relative increase of reticulocytes by >50% 1 week after initiation of oral iron. Results: EI was well tolerated 95 infants completed the trial to date, 76 died, were discharged or referred before day 61. (*p<.05) Conclusion: EI did not influence Fer at 61 days but decreased the incidence of ID and need for RCT and can be recommended. (Table)

Table 1 No caption available.