DO INFANTS WITH CYSTIC-FIBROSIS NEED A PROTEIN HYDROLYSATE FORMULA - A PROSPECTIVE, RANDOMIZED, COMPARATIVE-STUDY

Objectives: We compared the nutritional benefits of a protein hydrolys ate and a conventional infant formula in infants newly diagnosed with cystic fibrosis (CF). Study design: Twenty-three infants with CF (<6 m onths of age) and pancreatic insufficiency were randomized to receive a hydrolysate formula (Alimentum) or a cow's milk-based formula (Simil ac). Each patient was monitored at 1 month and then every 3 months for 1 year, Results: Eighteen patients (8 Alimentum, 10 Similac) complete d the study. At entry, the age distribution and clinical characteristi cs 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 differen ces in fecal energy or fecal fat at entry or throughout the study. Alt hough the hydrolysate-fed infants were slightly more malnourished at d iagnosis, growth velocity and nutritional status of infants with CF in each group were the same throughout the study, Conclusions: The resul ts of this randomized study fail to support the use of a hydrolyzed fo rmula for the routine care of infants newly diagnosed with CF.