Preterm Infant NEC Diagnosis Risk May Be Avoided With Donor Breast Milk, Instead of Cow Milk-Based Formula: Study

As the makers of Similac and Enfamil face a growing number of baby formula NEC diagnosis lawsuits, the findings of a new study seems to support a major allegation in the litigation, indicating that premature infants would be better off receiving breast milk from donors, instead of being given the cow milk-based products, which may help avoid cases of the severe and often life-threatening intestinal disease.

Necrotizing enterocolitis (NEC) is a devastating disease that mostly impacts premature infants, where the wall of the intestine is invaded by bacteria, leading destruction of the bowel and often requiring emergency surgery while the baby is still in the NICU.

Although Similac and Enfamil have been aggressively marketed for use among premature infants, increasing evidence has found that the cow milk formula products greatly increase the risk of a NEC diagnosis and health experts increasingly recommend breast milk instead of formula whenever possible.

In a study published in the medical journal Food & Nutrition Research, researchers sought to explore the effects of preterm donor milk on growth, feeding tolerance and severe morbidity among very low birth-weight infants, to evaluate whether donor milk may be a better alternative when the mother’s own breast milk is not available.

Researchers looked at 304 underweight preterm infants with a gestational age of less than 32 weeks, whose mothers were unable to provide sufficient milk. About half of the infants’ parents decided to use formula (PF) and the other half decided to use breast milk from donors (DM). Both groups of infants were treated using standard neonatal intensive care unit (NICU) protocols and observed for growth parameters, feeding tolerance, NEC and other severe morbidity.

According to the findings, both groups had similar daily weight gain and weekly head growth. However, those infants given breast milk had less feeding intolerance, were out of hospital faster, and were less likely to develop NEC or sepsis infections.

Prior research has established that premature infants fed baby formula are substantially more likely to be diagnosed with NEC, compared infants fed breast milk. However, the findings of this new study not only support the reduced risk of a preterm infant NEC diagnosis with the use of donor breast milk, but also address some questions about whether donor milk may compromise some functions after pasteurization.

“The study indicated that preterm [donor milk] does not affect the growth of very-low-birth-weight-infants. Further, it significantly reduces feeding intolerance, helps achieve full enteral feeding early, and has protective effects against necrotizing enterocolitis and sepsis,” the researchers concluded. “Thus, compared with formula, preterm [donor milk] can lower the rate of infection in preterm infants and is worthy of promotion.”

The findings are likely to be cited during proceedings in Enfamil and Similac lawsuits being pursued throughout the U.S. Court system, each raising similar allegations that Abbott and Mead Johnson knew or should have known their cow milk-based formula and fortifiers were unreasonably dangerous for premature babies, yet the companies continued to sell and distribute the products without providing adequate warnings to parents, hospitals and medical providers.

The lawsuits also claim the promotion of these cow milk formulas has displaced the use of breast milk and donor milk that infants would have otherwise received, which may have avoided the preterm infant NEC diagnosis.