The Design and Analysis of Studies in Premature Infants Using Human Donor Milk or Preterm Formula as Primary Nutrition: A Critique of Schanler et al.

Nutritional studies of human milk in pre-term infants provide a unique challenge in clinical research. In this paper we review the general tenets of good clinical design and analysis and show how they might be properly applied in these situations. The recommendations are then compared with the approach used in a recent study by Shanler et al. It is concluded that future trials should consider these key statistical design and analytical issues.