OBJECTIVE: A randomized, double-blind study was conducted comparing high-iron content (15 mg/L) with low-iron content (3 mg/L) premature formula given during initial hospitalization to infants with birth weights less than 1800 g to determine the influence of these differing intakes on the iron nutritional status during the first 4 months of life. A third group of similar infants received human milk mixed with an equal volume of liquid fortifier resulting in an iron content of approximately 1.7 mg/L. PATIENTS AND METHODS: Mean birth weight, gestational age, age at study entry, volume of blood removed for studies, and volume of red cells transfused were not different among the three groups. After hospitalization both formula-fed groups were given a cow milk formula with an iron content of 12 mg/L, and breast-fed infants were given an iron-containing multivitamin with a resulting iron intake of 10 mg/d. Infants were observed to 8 weeks after discharge. RESULTS: There were no differences in serum iron, ferritin, transferrin, transferrin saturation, hemoglobin, hematocrit, or reticulocyte count among the three groups at study entry, although mean corpuscular hemoglobin and mean corpuscular volume were lower in infants in the low-iron formula group. Mean plasma ferritin was significantly lower in infants receiving low-iron content premature formula at the time of hospital discharge compared with the other two groups. The incidence of anemia (hemoglobin < 9.0 g/dL) and low transferrin saturation (< 24%) was also greater in the low-iron content formula group. Eight weeks after discharge, the incidence of low plasma ferritin (< 19 ng/mL) remained greater in infants receiving low-iron content formula than in the other two groups. No adverse effects of iron intake were observed. Growth was not different among the three groups. CONCLUSIONS: These data indicate that preterm infants with < 1800 g birth weight receiving premature infant formula benefit from formula given during initial hospitalization containing 15 mg/L iron compared with that containing 3 mg/L.
RCT Entities:
OBJECTIVE: A randomized, double-blind study was conducted comparing high-iron content (15 mg/L) with low-iron content (3 mg/L) premature formula given during initial hospitalization to infants with birth weights less than 1800 g to determine the influence of these differing intakes on the iron nutritional status during the first 4 months of life. A third group of similar infants received human milk mixed with an equal volume of liquid fortifier resulting in an iron content of approximately 1.7 mg/L. PATIENTS AND METHODS: Mean birth weight, gestational age, age at study entry, volume of blood removed for studies, and volume of red cells transfused were not different among the three groups. After hospitalization both formula-fed groups were given a cow milk formula with an iron content of 12 mg/L, and breast-fed infants were given an iron-containing multivitamin with a resulting iron intake of 10 mg/d. Infants were observed to 8 weeks after discharge. RESULTS: There were no differences in serum iron, ferritin, transferrin, transferrin saturation, hemoglobin, hematocrit, or reticulocyte count among the three groups at study entry, although mean corpuscular hemoglobin and mean corpuscular volume were lower in infants in the low-iron formula group. Mean plasma ferritin was significantly lower in infants receiving low-iron content premature formula at the time of hospital discharge compared with the other two groups. The incidence of anemia (hemoglobin < 9.0 g/dL) and low transferrin saturation (< 24%) was also greater in the low-iron content formula group. Eight weeks after discharge, the incidence of low plasma ferritin (< 19 ng/mL) remained greater in infants receiving low-iron content formula than in the other two groups. No adverse effects of iron intake were observed. Growth was not different among the three groups. CONCLUSIONS: These data indicate that preterm infants with < 1800 g birth weight receiving premature infant formula benefit from formula given during initial hospitalization containing 15 mg/L iron compared with that containing 3 mg/L.