Human milk-based fortifiers slash mortality rate in preterm infants, study reveals
26 Jun 2024 --- An independent study, published in Nutrients, has found that human milk-based nutritional fortifiers reduce mortality rates by 50% in preterm infants. The study compared human milk-based fortifiers (HMBFs) with cow milk-based fortifiers (CMBFs) among premature infants who were fed a human milk diet of their mother’s milk or donor human milk.
The analysis evaluated short-term outcomes from four clinical studies involving 681 preterm infants born before 28 weeks of gestation and weighing less than 1,500 g.
Results showed that infants fed with HMBFs had a 50% lower mortality rate than those fed CMBFs. Another key finding revealed that infants who received human milk fortifiers showed a reduced risk of developing bronchopulmonary dysplasia, a chronic lung disease that impacts newborns.
“The data associates bovine (cow) milk-based fortifiers with a potentially increased risk of death in preterm infants, which possibly makes a reversal necessary,” notes the study, led by Dr. Radu Galis, neonatologist at Emergency County Hospital Bihor, Romania.
The authors say more research is required to study the link between human milk-based fortifiers and improved health outcomes for preterm infants. “The most important finding of our analyses was the reduction in mortality across all four clinical studies and data sets. Bovine milk products have been introduced into neonatal care without a safety consideration or parental verification.”

The study bodes well for medical-grade human milk-based nutritional product suppliers for critically ill and preterm newborns.
“The analysis underscores that human milk-based fortifiers can save lives for the most vulnerable patients,” says Dr. Melinda Elliott, fellow of the American Academy of Pediatrics, practicing neonatologist and chief medical officer at Prolacta Bioscience.
“Over 20 peer-reviewed studies and abundant real-world data from around the globe demonstrate the clinical benefits of human milk-based fortification for extremely premature infants.”
Reduced costs of HMBFs
Real-world data also supports the use of an Exclusive Human Milk Diet (EHMD) due to its ability to significantly improve the health of premature infants and reduce hospital costs.
Data from a study conducted between 2019 and 2022 involving more than 3,000 patients at over 60 US hospitals found that implementing EHMD not only improved health outcomes but also slashed costs by reducing comorbidities and shortening the length of hospital stays, resulting in a 2.6 times return on investment.
A recent study also found that term infants with gastroschisis who were exclusively fed HMBFs achieved full enteral feeds — receiving complete prescribed nutrition only through milk feeds — 30 days sooner and gained desirable weight faster than infants with the same condition who received cow milk-based fortifiers.
Overall, clinical studies affirm that HMBFs are safer and more suited to improving growth in term infants recovering from surgery and long-term outcomes such as neurodevelopment.