Meta-Analysis Finds Prolacta's Exclusive Human Milk Diet is Associated With 20% Lower Odds of Death in Premature and Very Low Birthweight Infants, Compared to Cow Milk-Based Diet

Pooled Analysis of 14 Studies Involving 4,713 Infants Found a Statistically Significant Reduction in Mortality Before Hospital Discharge

DUARTE, Calif., Oct. 27, 2026 /PRNewswire/ -- A systematic review and meta-analysis published in Frontiers in Nutrition found that an exclusive human milk diet (EHMD) was associated with a 20% reduction in mortality before hospital discharge among premature and very low birthweight (VLBW) infants, compared with diets containing cow milk-derived nutritional products.¹

The study, "Exclusive human milk diet and mortality before discharge in premature and very low birthweight infants: a systematic review and meta-analysis," analyzed 14 studies involving 4,713 infants, including five randomized controlled trials and nine non-randomized cohort studies.¹ 

The researchers compared an EHMD, defined as human milk fortified with Prolacta's human milk-based fortifier, with diets containing cow milk-based fortifiers or formula. The studies included infants born between 2004 and 2021, with mean birthweights ranging from 741 g to 1361 g and mean gestational ages ranging from 25.5 to 29.7 weeks.¹ 

"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," noted study authors. "The large, combined sample size improves statistical power to evaluate a relatively rare outcome such as survival to discharge."

Key findings:

• In the overall pooled analysis, an EHMD was associated with a statistically significant 20% lower odds of death before hospital discharge compared with diets containing cow milk-based products (OR, 0.80; 95% CI, 0.65-0.98; P = .03).¹ 

• The direction of association favored EHMD across both randomized controlled trials and non-randomized cohort studies.¹ 

"This comprehensive meta-analysis shows a consistent association favoring an exclusive human milk diet across different study designs," said Melinda Elliott, MD, FAAP, neonatologist and chief medical officer at Prolacta. "For 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. The 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 by Reyes and colleagues 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.² 

About Prolacta Bioscience
Prolacta Bioscience® is the global leader in human milk-based nutrition, dedicated to improving health outcomes for critically ill and premature infants. More than 125,000 vulnerable infants worldwide have benefited from Prolacta's human milk-based fortifiers and formulas since 2006.³ In a global first, Japan granted prescription drug status to Prolacta's PreemieFort® fortifiers in late 2025 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. Prolacta adheres to the industry's strictest quality and safety standards, operating pharmaceutical processing facilities and applying more than 20 donor milk screening tests. Its use of vat pasteurization inactivates pathogens while keeping human milk closer to its natural state than other human milk processing methods, preserving the bioactive components of human milk that support immune protection, brain development, and growth in premature and medically fragile infants.^4-6 Prolacta's 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. Learn more online or at X, Instagram, Facebook, TikTok, and LinkedIn. 

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SOURCE Prolacta Bioscience