What would happen in the United States if there were no cow milk-based preterm infant nutritional products: Historical perspective and evaluation of nutrient-related challenges.

Abstract

Recent litigation has led to a situation where preterm cow milk-based infant nutritional products (PCMBPs) may soon have limited or no availability in the United States. Given their limited availability, similar products based only on human milk are unlikely to meet the needs of most preterm infants requiring such products, especially those born greater than 1500 grams or very preterm infants born at less than 1500 g after they reach 34 to 35 weeks postmenstrual age. Alternative nutritional strategies, used prior to the introduction of specialized preterm products, would require modular nutrient additions to formula designed for full-term infants and donor or maternal milk. Addition of modular products would require careful calibration to provide needed macro and micronutrients which would expose infants to risks of contamination, poor growth, and limited bioavailability of some of these modulars. Substantial risks of metabolic derangements, and ultimately, poor outcomes would occur. In the long-term greater availability and support for the use of human milk-based products is needed. However, policy makers cannot assume that PCMBPs will not be critically needed and should identify strategies for their continued marketplace availability.