Clinical research on infant nutrition is conducted in full conformance with the principles of the World Medical Association Declaration of Helsinki and the International Conference on Harmonisation (ICH) guidelines for Good Clinical Practice, as appropriate for nutritional products. NUT-14 - Getting issue details... STATUS Studies to determine the clinical effects of a product can be investigated in observational studies as well as interventional studies with the object of ascertaining its safety and/or efficacy.
The World Health Organization recommends exclusive breastfeeding for the first 6 months of life, and thereafter with complementary feeding up to 2 years of age and beyond.Breastfeeding subjects are often included in the study protocol and used as a reference.
Pre-term infant nutrition is often fortified and the caloric density determined. The subjects in a pre-term study can also receive fortified or unfortified human milk from the mother or from a donor. The modeling of pre-term infant nutrition is being handled by the Combination Therapy sub-team, focusing on finding a unified approach that can be applied across all disease areas and which will take account of this nutrition concept; it is therefore not included in this document.
Figure 4.1 below represents the concepts of interest in this document to feed preparation, administration and events related to feeding.
Figure 4.1 Concept Map: Infant Nutrition