Prolacta’s 100% Human Milk-Based Fortifiers Lower the Risk of Multiple Complications and Death Among Preterm Infants, Compared to Fortifiers Made From Cow Milk, Says New Study

DUARTE, Calif., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Prolacta Bioscience®, the world’s leading hospital provider of 100% human milk-based nutritional products, announced today the results of a new meta-analysis involving more than 450 very low birth weight (VLBW) premature infants. The report, published in Neonatology Today, found those fed a diet of human milk had a lower risk of complications and/or death when Prolacta’s 100% human milk-based fortifiers were added to mother’s own milk or donor human milk rather than cow milk-based fortifiers.

To support the rapid growth that takes place during their first weeks of life, very preterm infants typically require a nutritional fortifier added to their feeds to provide the calories and protein they need. There are two kinds of fortifiers available: cow milk-based and Prolacta’s 100% human milk-based.

Numerous studies have demonstrated that VLBW infants fed cow milk-based products, rather than human milk-based fortifiers, may have a greater risk of adverse outcomes, including late-onset sepsis,1,2,3 bronchopulmonary dysplasia (BPD),1,4,5 necrotizing enterocolitis (NEC),1,5,6,7,8 and mortality.3

However, few studies have directly compared outcomes of the use of cow milk-based versus human milk-based fortifiers among VLBW infants fed a base diet of human milk (as opposed to cow milk-based formula or a combination of the two). To address this question using as much of the available evidence as possible, Lucas et al.9 gathered data from three studies, including two prospective, randomized clinical trials, and compared outcomes of 453 preterm infants fed a base diet of mother’s or donor milk and fortified with Prolacta’s fortifiers or cow’s milk-derived fortifier (CMDF). Meta-analyses of data from the three studies showed that when compared with the Prolacta human milk-derived fortifier (HMDF) group, the CMDF group was associated with:

  • 40% higher risk of a positive mortality/morbidity index in the CMDF group (RR = 1.4; P = 0.006), when the same index from the O’Connor et al. study10 was applied to the combined meta-analysis1,5,8,10
  • 2.4-fold higher risk for retinopathy of prematurity (ROP) (RR = 2.4; P = 0.001)
  • 3.3-fold higher risk for NEC (RR = 3.3; P = 0.008)

“These findings provide additional evidence that adding a cow milk-based fortifier to mother’s or donor milk not only reduces the health benefits of that milk, but increases the risk of complications and mortality,” said Melinda Elliott, M.D., chief medical officer of Prolacta. “In contrast, nurturing these vulnerable infants with an exclusive human milk diet that includes Prolacta’s 100% human milk-based fortifiers not only increases their odds of survival, but also reduces the risk of the most serious complications. Human milk for human babies just makes sense.”

About Prolacta Bioscience
Prolacta Bioscience® Inc. is a privately held life sciences company dedicated to Advancing the Science of Human Milk®. Prolacta is the world’s leading hospital provider of 100% human milk-based nutritional products. The company is exploring the therapeutic potential of human milk across a wide spectrum of human diseases, including applications for infants requiring surgery for congenital cardiac and gastrointestinal disorders. Operating the world’s first pharmaceutical-grade human milk processing facilities, Prolacta leads the industry with the highest quality and safety standards for the screening and testing of donor milk. Prolacta is a global company with headquarters in Duarte, California, and can be found online at, on Twitter @prolacta, on Instagram @prolacta_bioscience, on Facebook at and LinkedIn at

Media Contact:
Loren Kosmont


  1. Lucas A, Boscardin J, Abrams SA. Preterm infants fed cow's milk–derived fortifier had adverse outcomes despite a base diet of only mother's own milk. Breastfeed Med. 2020;15(5):297-303. doi:10.1089/bfm.2019.0133
  2. Hair AB, Rechtman DJ, Lee ML, Niklas V. Beyond necrotizing enterocolitis: other clinical advantages of an exclusive human milk diet. Breastfeed Med. 2018;13(6):408- 411. doi:10.1089/bfm.2017.0192
  3. Abrams SA, Schanler RJ, Lee ML, Rechtman DJ. Greater mortality and morbidity in extremely preterm infants fed a diet containing cow milk protein products. Breastfeed Med. 2014;9(6):281-285. doi:10.1089/bfm.2014.0024
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  9. Lucas A, Assad M, Sherman J, Boscardin J, Abrams S. Safety of cow’s milk-derived fortifiers used with an all-human milk base diet in very low birthweight preterm infants. Neonatol Today. 2020;15(7):3-13. Accessed July 22, 2020.
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