FDA, CDC, NIH Consensus Statement on Recent Advisory Council Report on Premature Infants and Necrotizing Enterocolitis

Report Indicates Benefits of Human Milk in Protecting Against NEC and No Conclusive Evidence that Preterm Infant Formulas Cause NEC

Ensuring that the youngest and most vulnerable children have access to safe and nutritious sources of food is a top priority for the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health.  Infant nutrition is critically important for brain and organ development.

Preterm infants have complex nutrition needs to support critical growth and development requirements. They are also at higher risk of a devastating condition called necrotizing enterocolitis, or NEC, in which the tissue lining the intestine becomes inflamed and can die, causing a life-threatening infection. In fact, NEC is one of the leading causes of illness and death among preterm infants, particularly those born at a very low birth weight. It is estimated that one baby dies every day in the United States from NEC, and those that survive may undergo traumatic surgeries, be neurodevelopmentally impaired, and have lifelong consequences.

While mother’s milk is the preferred source of nutrition – with pasteurized donor human milk as a next best alternative – preterm infant formulas are a critically important option for premature infants. These formulas can be critical for premature infants for whom parental or donor milk is not an option, or where a supplement to parental or donor milk is necessary for the health of the infant. For infants where the supply of human milk is insufficient, these formulas are part of the standard of care for premature infants.

There has been ongoing public discussion about the current state of science and research gaps regarding NEC, particularly as it relates to preterm infant formulas. Recently, an advisory council for the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development finalized a comprehensive report.

There are two key points about feeding practices and NEC: 1) There is no conclusive evidence that preterm infant formula causes NEC; and 2) there is strong evidence that human milk is protective against NEC.  Available evidence supports the hypothesis that it is the absence of human milk – rather than the exposure to formula – that is associated with an increase in the risk of NEC. Further, human milk significantly reduces, but does not eliminate, the risk of NEC, given that NEC is known to occur in infants fed exclusively human milk diets.  

Evidence to date suggests that preterm birth is the primary risk factor for developing NEC, but important scientific gaps exist for understanding the epidemiology of NEC, biologic mechanisms of NEC and the exposures and feeding practices that may be positively or negatively associated with the risk of NEC development, severity and mortality.

As collective work continues on this important topic, one point remains clear: while there is a preference for human milk, all infants should be fed as soon as is medically feasible through whatever appropriate nutritious food source is available.