Prolacta’s meta-analysis links human milk diet to 20% lower odds of death in preterm infants

A systematic review and meta-analysis examining premature and very low birth weight (VLBW) infants associates an exclusive human milk diet (EHMD) with 20% lower odds of mortality before hospital discharge, compared with diets based on cow milk-derived nutritional products.

The researchers compared an EHMD — human milk fortified with Prolacta Bioscience’s human milk-based fortifier — with diets containing cow milk-based fortifiers or formula. The company commissioned and funded the review of studies.

In the overall pooled analysis published in Frontiers in Nutrition, researchers analyzed 14 studies involving 4,713 infants, including five randomized controlled trials and nine non-randomized cohort studies.

The studies included infants born between 2004 and 2021, with mean birthweights ranging from 741 g to 1,361 g and mean gestational ages ranging from 25.5 to 29.7 weeks.

“A strength of this review is the inclusion of both randomized and non-randomized evidence, enabling assessment of the totality of available data and increasing applicability to real-world practice,” say the study authors.

“The large, combined sample size improves statistical power to evaluate a relatively rare outcome such as survival to discharge.”

Pooling research data

In the paper, an EHMD was associated with statistically significant 20% lower odds of death before hospital discharge compared with diets containing cow milk-based products.

The direction of association favored EHMD across both randomized controlled trials and non-randomized cohort studies. However, neither trial groups showed a statistically significant difference when analyzed separately. The 20% figure emerged when both results were pooled and relied on one large observational study.

“This comprehensive meta-analysis shows a consistent association favoring an exclusive human milk diet across different study designs,” says Melinda Elliott, M.D., neonatologist and chief medical officer at Prolacta.

“For neonatal intensive care unit (NICU) teams caring for very low birthweight infants, it adds meaningful data to the nutrition decisions made in the earliest days of life.”

Prolacta human milk-based fortifiers (Image credit: Prolacta Bioscience).The findings add to 20 years of expanding research demonstrating the benefits of an EHMD in the care of VLBW infants. This evidence base includes extensive research on necrotizing enterocolitis (NEC), a devastating intestinal disease that is a leading cause of death and disability in premature infants.

A 2025 systematic review and meta-analysis found that an EHMD with human milk-based fortifiers was associated with lower odds of medical and surgical NEC, compared with diets containing cow milk-based nutritional products.

Pharma-grade safety standards

Prolacta says it adheres to pharmaceutical standards at its processing facilities and applies more than 20 donor milk screening tests. The manufacturer’s use of vat pasteurization inactivates pathogens while keeping human milk closer to its natural state than other human milk processing methods, says the company.

This preserves the bioactive components of human milk that support immune protection, brain development, and growth in premature and medically fragile infants, according to the company.

Prolacta says that its products have been evaluated in more than 30 peer-reviewed clinical studies, demonstrating the short- and long-term health benefits of its patented human milk-based fortifiers and formulas.

In a global first, Japan granted prescription drug status to Prolacta’s PreemieFort fortifiers for very low birthweight infants, infants with congenital gastrointestinal disorders or congenital heart disease, and those recovering from gastrointestinal surgery at risk for poor growth.