PEDIATRICS Vol. 75 No. 3 March 1985, pp. 514-518
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Effect of Formula Supplementation in the Hospital on the Duration of Breast-Feeding: A Controlled Clinical Trial

Katherine Gray-Donald PhD1, Michael S. Kramer MD1, Susan Munday PDt1, and Denis G. Leduc MD1

1 From the Departments of Epidemiology and Biostatistics and Pediatrics, McGill University Faculty of Medicine, and The Royal Victoria Hospital, Montreal

To avoid methodologic pitfalls in previous observational studies linking formula supplementation in the hospital to early discontinuation of breast-feeding, a controlled clinical trial of restricted supplementation was conducted. In a pretrial sample of 621 newborns, a comparison of two "well-baby" nurseries found no differences in either hospital supplementation practices or the proportion of infants still being breast-fed at 4 or 9 weeks postpartum. Restriction of supplementation in one of the nurseries for the trial period (n = 781) did not result in higher breast-feeding rates at 4 or 9 weeks. There was, however, a slightly greater mean percent of birth weight lost in the restricted group (6.0% v 5.1%; P < .001). In examining the control group for evidence of an "observational" association, it was found that infants still breast-feeding at 4 or 9 weeks were far more likely to have been unsupplemented than those no longer being breast-fed. It thus appears that formula supplementation in the hospital is a marker, rather than a cause, of breast-feeding difficulty.

Key Words: breast-feeding • formula supplementation • clinical trials

Submitted on December 5, 1983
Accepted on May 14, 1984




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