Study design (if review, criteria of inclusion for studies)
RCT
Participants
23 infants with CF (<6 months of age) and pancreatic insufficiency
Interventions
Patients were randomized to receive a hydrolysate formula (Alimentum) or a cow's milk-based formula (Similac).
Outcome measures
growth velocity and nutritional status. Each patient was monitored at 1 month and then every 3 months for 1 year.
Main results
18 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.
Authors' 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.