Human Factors-Related Formulas

Professionals working in the area of human factors have developed many mathematical formulas for estimating various types of human factors-related information. Some formulas that are useful for performing patient safety-related analysis are presented below. 

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From a research standpoint, clinical studies that assess the effects of new ingredients will be difficult to design because infants cannot be randomized to be formula fed or breastfed. Furthermore, there may be significant non-nutritional confounding variables between the groups, including, but not limited to, factors related to which mothers breastfeed. Finally, human-milk composition varies considerably among individuals and within individuals over time, while infant formula content remains constant. 

The only potential human health concern related to cows treated with BST was the possible increase in the level of a second peptide hormone related to the action of growth hormone, insulin-like growth factor-I (IGF-I). IGF-I is a 70 amino acid peptide and, in many respects, is structurally similar to insulin. When the milk from BST-treated cows was assayed for IGF-I, it had concentrations comparable to that found in human breast milk and well within normal levels of biological exposure. Since it is a large peptide similar to insulin and BST, IGF-I also is not absorbed after oral administration for all the reasons discussed above. However, there was still concern regarding its presence in infant formula because of the increased exposure and vulnerability of babies. Further studies showed that any IGF-I present in milk from normal or BST-treated cows was destroyed in the formula manufacturing process. Again the safety of BST-treated milk was demonstrated ... 

There are factors in maternal milk that maintain neonatal gastrointestinal integrity. For example, breast milk has been shown to be protective against necrotizing enterocolitis (NEC), a serious disease characterized by ulceration and necrosis of the neonatal gastrointestinal tract. In a prospective multicenter study involving 926 preterm infants, Lucas and Cole (1) demonstrated that the incidence of NEC was 6-10 times more common in neonates fed conventional infant formula than in neonates fed breast milk. Additional evidence for the protective effect of human milk was provided by Schanler et al. (2), who reported that the incidence of NEC in a randomized clinical trial involving 171 preterm infants was inversely related to the quantity of human milk fed. 

Human milk is a true prebiotic, and its neutral oligosaccharides are known as the main bifidus factor [404], which prevents digestive tract infections because it induces and improves the growth of good intestinal flora. The prebiotic concept was developed by Gibson and Roberfroid in 1995 [410]. According to their definition, a prebiotic effect is proven when bifidobacteria, lactobacilli, and other healthy bacteria are specifically stimulated and potentially harmful bacteria are depressed [411]. The concept of using prebiotics in infent formulas is related to three basic assumptions [412] ... 

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