NICC Study: Neocate in infants and children with complex conditions
Research type
Research Study
Full title
An open-label, explorative, post launch study of Neocate amino acid-based feeds to evaluate nutritional status and gastrointestinal tolerance in infants and children with complex conditions
IRAS ID
271838
Contact name
Rosan Meyer
Contact email
Sponsor organisation
Nutricia Research BV
Duration of Study in the UK
1 years, 9 months, 26 days
Research summary
Infants and young children up to 10 years of age with a complex condition involving the gastrointestinal tract are at risk of poor nutritional status, including faltering growth. Due to the complex condition, standard nutrition is often not tolerated causing symptoms such as abdominal pain or discomfort, nausea, vomiting, diarrhoea and/or constipation. Formulas in which proteins are cut into smaller pieces, called amino acids, are easier for the body to absorb and digest. These formulas might be tolerated better and reduce gastrointestinal symptoms in infants and young children with complex conditions. An amino acid-based formula, such as Neocate, is therefore regularly used as primary source of nutrition.
The objectives of the present, exploratory study are to gain clinical evidence related to the nutritional status (i.e. anthropometrics, biomarkers of nutritional status, nutrient intake) and gastrointestinal tolerance of infants and young children with complex conditions receiving Neocate as their primary source of nutrition for 4 weeks, 16 weeks and 52 weeks after study entry. Additional objectives are to describe the nutritional and pharmacological management of these infants and young children, specifically their diagnoses, medication use and indication for use of Neocate. The latter will be done by describing the type of prior monitoring (i.e. nutritional management, anthropometry and biochemical markers), the clinical details at baseline (i.e. diagnoses) and the feed specifications, indications and concomitant medication use (i.e. Neocate indication, route of feed and additional nutritional intake).
Study duration for each participant will be 52 weeks at maximum. If before this timepoint Neocate is no longer clinically indicated and if Neocate is no longer providing ≥50% of the energy intake, study participation will be discontinued.
The study will be carried out in 40 children up to 10 years of age at several hospitals/clinics globally and is being run by Nutricia Research.REC name
Wales REC 4
REC reference
20/WA/0036
Date of REC Opinion
23 Mar 2020
REC opinion
Further Information Favourable Opinion