Tolerance and Safety of Energy-Dense Enteral Formulae for Young Children

The safety and tolerance of energy-dense enteral pediatric formulae were evaluated and compared with a standard formula. Children aged 1-6 years requiring tube feedings to provide ≥ 75% of their daily estimated energy needs for 21 days were evaluated in this phase III, randomized, open-label, multicenter study. Subjects received a control formula, Pediasure® (C; 1.0 kcal/mL) or an experimental formula similar in nutrient composition but higher in caloric density (1.5 kcal/mL) with or without fiber (EF and E, respectively). Subjects (n=94) returned for 3 weekly visits. Gastrointestinal parameters improved (p<0.05) in all groups. Energy intake was comparable among groups, but was achieved with lower (p<0.0001) volumes in E and EF relative to C. Weight gain was greater (p<0.01) in E versus C. Adverse event reporting was similar among groups. Energy dense formulae are an option for children with fluid restrictions or increased energy or fiber needs without compromising safety or tolerance.