Trial Status: Open
Nutritional feeds in the form of either enteral tube feeds or oral nutritional supplements are commonly used to meet the entire or partial nutritional requirements of children who demonstrate faltering growth or other medical conditions where they cannot meet their nutritional requirements sufficiently with food.
In recent years some patient groups have begun to administer homemade blended foods via their feeding tubes, instead of using commercially available feeds, which is especially prevalent among paediatric patients. Although recognition of this practice from professional bodies is low, anecdotal evidence does show some benefits. Nonetheless, there are concerns with this practice including compromised nutritional consistency, microbiological safety and enteral tube integrity. This presents a problem for some parents who wish to provide their child with a source of nutritional support based on real food without posing any additional risks. Nutricia has recognised the changing needs of these paediatric patients and has therefore extended its existing range of paediatric feeds to include new formulations which include real food ingredients (> = 14%). These new formulations are designed for children with faltering growth/disease-related malnutrition from 1 year of age, are suitable as a sole source of nutrition and provide a sterile, standardised consistency and nutritional content.
A clinical trial is therefore required to evaluate the tolerance, compliance, acceptability, and safety of three new enteral tube feed and oral nutritional supplement formulations, based on real food ingredients (1kcal/ml and 1.5kcal/ml enteral tube feeds and a 1.5kcal/ml oral nutritional supplement). This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period. During the intervention period, patients will receive one of the study products for 28 days as a sole source of nutrition or alongside any additional routine nutritional management as required. Additional outcomes include nutritional intake, anthropometrics, and gastro-intestinal health-related quality of life.