There is no conclusive evidence that specialty formulas for preterm infants cause necrotizing enterocolitis (NEC), according to a consensus statement from the Food and Drug Administration, Centers for Disease Control and Prevention (CDC) and National Institutes of Health. Rather, evidence supports the hypothesis that the absence of human milk is associated with an increased risk of NEC.
“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,” according to the statement.
The agencies noted that specialty formulas can be critical for premature infants when parental or donor milk is not an option or when an infant needs a supplement to parental or donor milk.
“For infants where the supply of human milk is insufficient, these formulas are part of the standard of care for premature infants,” according to the consensus statement.
Earlier this year, two formula companies were ordered to pay millions of dollars in damages after juries determined their products were responsible for NEC in preterm infants. The verdicts and similar lawsuits could threaten the availability of specialty formula.
NEC is a serious gastrointestinal condition noted by inflammation of the intestine, which can lead to necrosis of the colon and intestine, which can result in sepsis. It was responsible for the deaths of 356 infants in 2022, according to the CDC.
The consensus statement agrees with a Sept. 16 report from the National Advisory Child Health and Human Development (NACHHD) Council’s NEC working group, which states that all infants should be fed as soon as is medically feasible, by whatever means possible.
It points to an AAP clinical report that recommends a mother’s own milk, appropriately fortified, as the optimal nutrition source for infants with very low birthweight. The best alternative is pasteurized human milk from a donor, followed by infant formula. Specialized formula for preterm infants may be the best option for some families.
The NEC working group, chaired by Yvonne “Bonnie” Maldonado, M.D., FAAP, a member of the AAP Section on Infectious Diseases, and Ravi M. Patel, M.D., M.Sc., FAAP, a member of the AAP Section on Neonatal-Perinatal Medicine Executive Committee, also called for more research to help parents and health care providers determine the best nutrition plan for premature infants.
The AAP is concerned that lawsuits against specialty formula makers threaten the availability of formulas that provide important nutrition for preterm infants.
“Courtrooms are not the best place to determine clinical recommendations for the care of infants,” AAP President Benjamin D. Hoffman, M.D., FAAP, said in a recent statement. “Feeding decisions should be made by clinicians and families. These need to be individualized in the context of human milk availability, specific patient needs, and individual family preferences.”
