Abstract

We read with interest the recently published clinical report by Baker, Greer, and the American Academy of Pediatrics Committee on Nutrition1 but were astonished to find that the authors recommended changing the recommendation on provision of iron, now to include all breastfed infants, on the basis of 1 clinical study while ignoring clinical studies that have suggested adverse effects of this practice. This is especially surprising because they, in their introduction, emphasized the need for larger studies and systematic reviews for evaluating the potential correlation between iron-deficiency anemia (IDA) and iron deficiency (ID) and neurodevelopment; they concluded that “an unequivocal relationship between IDA and ID and neurodevelopmental outcomes has yet to be established.” In a study by Friel et al,2 which is the basis for the new recommendations, term breastfed infants were randomly selected to receive either 7.5 mg/day of elemental iron as ferrous sulfate or placebo from 1 month (study entry) to 6 months of age, and anthropometry and hematologic indexes were evaluated at entry and at 3½, 6, and 12 months of age. In addition, Mental and Psychomotor Developmental Indexes were assessed by using the Bayley scales, and visual acuity was assessed by Teller cards at 12 to 18 months of age. One problem, which the authors acknowledged, is that the study was underpowered, partially because of the low initial breastfeeding rate in the population studied and partially because of the high drop-out rate. In fact, the authors' power calculation led them to conclude that 100 infants would be needed in each group to detect a 5% difference in the Mental and Psychomotor Developmental Indexes, but at 12 months of age only 26 and 20 infants, respectively, were available for intention-to-treat analyses, and only 24 and 17 had received iron for >30 days (of the intended …

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