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

JAPAN – 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,” said 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 group 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,” said 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.

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.

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