The first one [11], published in 2001, concluded that modifications of infant feeding regimens and dietary products need to be evaluated in clinical trials meeting accepted standards of scientific methodology. In 2003 [12], the committee proposed, for general discussion, a list
of core data that should be recorded in nutrition trials and suggested principles for the identification of data required for studies with different outcome measures. It was stated that the choice of measures of efficacy and safety is determined by the nature of the study and the hypothesis being tested. With regard to growth, the CoN suggested that growth measures be recorded in all nutrition trials involving infants and children, as safety if not as outcome measures. Examples of factors that may affect growth or body composition were summarized. These included birth weight for gestation (g and SD score for gender and gestation), gender of the infant, parental heights and weights, maternal smoking, and maternal alcohol,
drug or substance abuse.
The first one [11], published in 2001, concluded that modifications of infant feeding regimens and dietary products need to be evaluated in clinical trials meeting accepted standards of scientific methodology. In 2003 [12], the committee proposed, for general discussion, a list of core data that should be recorded in nutrition trials and suggested principles for the identification of data required for studies with different outcome measures. It was stated that the choice of measures of efficacy and safety is determined by the nature of the study and the hypothesis being tested. With regard to growth, the CoN suggested that growth measures be recorded in all nutrition trials involving infants and children, as safety if not as outcome measures. Examples of factors that may affect growth or body composition were summarized. These included birth weight for gestation (g and SD score for gender and gestation), gender of the infant, parental heights and weights, maternal smoking, and maternal alcohol, drug or substance abuse.
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