Donor Milk Just as Good as Infant Formula for Extremely Preterm Infants, With Less Risk of NEC: Study

Preemies fed infant formula were more than twice as likely to develop necrotizing enterocolitis than those fed donor human milk, researchers found.

Although infant formula and fortifiers are often recommended for premature infants when mothers are unable to breast feed, the findings of a new study found that neurodevelopment outcomes for extremely preterm infants are just as good as when the babies are fed donor milk, and it may reduce the risk of serious and potentially life-threatening health risks for preemies linked to cow’s milk-based infant formula products.

In recent years, there has been a growing consensus among doctors and scientists that breast milk is safer, and potentially healthier, for preterm infants than infant formula products, like Similac and Enfamil, which have been widely marketed as a healthy alternative to a mother’s breast milk for decades. However, side effects of Similac and Enfamil have been linked to an increased risk of necrotizing enterocolitis (NEC), which causes the intestines to become inflamed and die.

In this new study, researchers from several medical universities across the U.S. indicate there was little to no difference in two-year neurodevelopmental outcomes for infants fed either donor milk or infant formula, yet more babies developed NEC on infant formula compared to donor milk.

Infant Formula Concerns

A number of prominent health organizations have raised concerns about the aggressive marketing of Similac, Enfamil and other formula products over the past decade, which promote the cow’s milk-based formula as a safe alternative for premature infants.

False and misleading statements have been blamed for driving many families away from breastfeeding, and suppressed demand for human donor milk, while also increasing the incidence of NEC from infant formula.

These allegations have also been raised in a number of Similac lawsuits and Enfamil lawsuits being pursued by families of premature babies who developed this severe and life-threatening intestinal afflication.

Families allege that the formula manufacturers knew that products like Similac and Enfamil cause NEC at substantially higher rates than is seen among premature babies fed breast milk or donor milk alone, yet the products were actively promoted use of among newborns still in the NICU. The manufacturers even introduced specific formulations of Similac and Enfamil for use among premature babies, which has been blamed for causing many cases of avoidable NEC injuries.

In a new study published this week in the Journal of the American Medical Association (JAMA), researchers conducted a double-blind, randomized clinical trial at 15 U.S. academic medical centers, all of which belonged to the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network.

They looked at data on infants born after less than 29 weeks of gestation, or with a birth weight of less than 1,000 grams between September 2012 and March 2019. The study examined whether the infants were fed preterm infant formula or donor human milk, and followed them either until they were discharged from the hospital, died, or were released from the hospital.

The study involved 483 infants, about half of whom were given infant formula and half donor human milk. After two years there was very little difference in cognitive and language scores, and death rates.

While weight gain was slightly lower in the donor milk group, the rate of NEC was 9% among those fed infant formula, and only 4.2% among the group fed donor human milk.

“Among extremely preterm neonates fed minimal maternal milk, neurodevelopmental outcomes at 22 to 26 months’ corrected age did not differ between infants fed donor milk or preterm formula,” the researchers concluded.

The findings may impact evidence that will be presented in hundreds of necrotizing enterocolitis lawsuits being pursued against the manufacturers of Similac and Enfamil, which are currently being prepared for a series of early bellwether trials that may be ready to go before juries in the second half of 2024.