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Extensively hydrolyzed formulas (eHF) are indicated for infants with food protein allergy. The purpose of the study was to assess the tolerance and compliance of an intended population of infants to a new formulation of a hypoallergenic eHF.
A non-random, single-group, multicenter study was conducted. Infants with suspected food protein allergy, persistent feeding intolerance, or presenting conditions where an eHF was deemed appropriate were enrolled in a 15-day feeding trial. Intake, stool patterns, weight (wt), length, and questionnaires were collected. The primary outcome was maintenance of wt for age Z-score during the study.
25 infants (85 ± 8.9 d of age) were enrolled; 7 were ≥ 4 months; 4 were preterm. At entry, 12 had symptoms of allergic colitis or food protein allergy/intolerance, 12 had persistent formula intolerance, 11 had hematochezia/heme positive stools, and 1 was recovering from necrotizing enterocolitis. Mean wt for age Z-score was -0.62 ± 0.19 at entry and -0.41 ± 0.16 at exit. Mean change in wt for age Z-score was 0.21 ± 0.10. Mean formula intake was 764 ± 48 mL/day. The mean number of stools/day was 1.8 ± 0.4 and the predominant stool consistencies were loose/mushy (48%) or soft (43%).
The results suggest that this eHF was well accepted and tolerated by an intended use population of infants during the first 6 months of life which enabled adequate volume consumption, maintenance of wt for age Z-scores and a high level of parental satisfaction.