Do infants with cystic fibrosis need a protein hydrolysate formula? A prospective, randomized, comparative study.

OBJECTIVES: We compared the nutritional benefits of a protein hydrolysate and a conventional infant formula in infants newly diagnosed with cystic fibrosis (CF). STUDY DESIGN: Twenty-three infants with CF (<6 months of age) and pancreatic insufficiency were randomized to receive a hydrolysate formula (Alimentum) or a cow's milk-based formula (Similac). Each patient was monitored at 1 month and then every 3 months for 1 year. RESULTS: Eighteen patients (8 Alimentum, 10 Similac) completed the study. At entry, the age distribution and clinical characteristics of each group were comparable. Energy intake with each formula was the same at 1 and 3 months, but at 6 and 12 months the hydrolysate-fed infants had higher age-adjusted energy intake. There were no differences in fecal energy or fecal fat at entry or throughout the study. Although the hydrolysate-fed infants were slightly more malnourished at diagnosis, growth velocity and nutritional status of infants with CF in each group were the same throughout the study. CONCLUSIONS: The results of this randomized study fail to support the use of a hydrolyzed formula for the routine care of infants newly diagnosed with CF.