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Statistical considerations in infant nutrition trials
Author(s) -
Gore Sheila M.
Publication year - 1999
Publication title -
lipids
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.601
H-Index - 120
eISSN - 1558-9307
pISSN - 0024-4201
DOI - 10.1007/s11745-999-0353-0
Subject(s) - protocol (science) , randomization , randomized controlled trial , set (abstract data type) , clinical trial , medicine , computer science , pediatrics , medical physics , alternative medicine , surgery , pathology , programming language
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.