Statistical considerations in infant nutrition trials.

Infant nutrition trials usually require developmental follow-up, often to 18 mon, and sometimes beyond reading ability at age 7 yr. They are therefore logistically complex and costly, and should be conducted to a high statistical standard. With examples, we focus on: good practice in nutrition trials and the goal of a common protocol; how to set plausible trial targets and to work out trial size accordingly; statistical observations on assessing visual maturation; and methods of randomization, including the method known as minimization, which can be adapted to select more appropriately a comparison cohort of breast-fed infants. We end with discussion of analysis and reporting standards, including the give-aways (or tell-tale signs) to be on the look out for. A Cochrane Collaboration for systematic review of randomized trials of infant nutrition is proposed.