Abstract 662
Poster Session II, Sunday, 5/2 (poster 150)
Formula thickened with rice cereal is often used in the dietary management of infant regurgitation. Pre-thickened formula has recently become available in North America; therefore, it is important to evaluate its nutritional adequacy. Methods: In a double-blind, randomized, controlled, parallel-group trial we evaluated the nutritional adequacy of a milk-based formula in which 30% of the lactose was replaced by pregelatinized, waxy rice starch (added rice-AR). Healthy, term, formula-fed infants with a birth weight of at least 2500 g were stratified by gender and randomized to receive a routine milk-based formula (control) or AR. Anthropometric data were collected at 14, 30, 60, 90 and 120 days of age. Results: Of 272 subjects enrolled (n=136 per group), 106 control subjects and 91 test subjects completed the study. No significant differences were detected between formula groups in rates of weight gain from 14 to 30, 60, 90 or 120 days. The study had 92% power to detect what is accepted as a clinically relevant difference in weight gain (3 g/day) at the end of the study. By 60 days, mean growth was at or above the 75th percentile established by the National Center for Health Statistics in both groups. There were no statistically significant differences between the groups in length or head circumference growth rates. Conclusion: In term infants, AR supported growth as effectively as a commercially available routine formula.
