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Clinical research on infant nutrition is conducted in full conformance with the principles of the World Medical Association Declaration of Helsinki[1] and the International Conference on Harmonisation (ICH) guidelines for Good Clinical Practice[2], 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.[3] 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

Concept Map: Infant Nutrition


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