Human Milk-Based Fortifiers Cut Mortality Rate by 50% in Preterm Infants, Independent Study Shows

Meta-Analysis Reveals Lifesaving Impact of Human Milk-Based Fortifiers Over Cow Milk-Based Fortifiers

DUARTE, Calif., June 25, 2024 /PRNewswire/ -- An independent study published in the journal Nutrients found a 50% reduction in mortality among preterm infants fed human milk-based nutritional fortifiers. The meta-analysis assessed short-term outcomes, comparing human milk-based fortifiers (HMBFs) with cow milk-based fortifiers (CMBFs) in premature infants fed a human milk diet of mother's own milk (MOM) or donor human milk (DHM). The analysis comprised data from four clinical studies involving 681 preterm infants born at <28 weeks of gestation, with a birth weight of <1,500 g. Key findings:

    --  Use of a human milk diet with human milk-based fortifiers reduced
        mortality by 50% compared to a diet with cow milk-based fortifiers(1) (p
        = 0.03).
    --  A trend toward reduced bronchopulmonary dysplasia (BPD) with human milk
        fortifiers that approached statistical significance(1) (p = 0.05).

"The data associates bovine (cow) milk-based fortifiers with a potentially increased risk of death in preterm infants, which makes a reversal possibly necessary," notes the study, led by Radu Galis, MD, neonatologist at Emergency County Hospital Bihor in Romania. While the authors call for additional research, they concluded: "The most important finding of our analyses was the reduction in mortality across all four clinical studies and data sets." The authors also note, "Bovine (cow) milk products have been introduced into neonatal care without a safety consideration or parental verification."

"The analysis underscores that human milk-based fortifiers can save lives for the most vulnerable patients," said Melinda Elliott, MD, FAAP, 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."

This meta-analysis was independent of Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill and premature infants.

Real-World Evidence Shows Improved Outcomes and Reduced Costs of Human Milk-Derived Fortifiers
Extensive real-world data affirm that adoption of an Exclusive Human Milk Diet (EHMD) enables critical health improvements for premature infants and major cost reductions for hospitals. Analysis of 2019-2022 data from more than 3,000 patients at 60+ U.S. hospitals found EHMD implementation improved health outcomes and reduced costs, generating a 2.6X dollar-for-dollar return on investment.(2) Similarly, a 2023 peer-reviewed report found EHMD implementation resulted in a 3X dollar-for-dollar return on investment from a reduction in comorbidities and shorter lengths of stay among very low birth weight infants.(3)

The body of real-world evidence in support of HMBFs is substantial. It has been clinically proven in more than 20 peer-reviewed clinical studies that compared to CMBFs, HMBFs when used as part of an EHMD demonstrated:

    --  Lower mortality and morbidity(4-6)
    --  Reduced incidence of feeding intolerance(7)
    --  Achievement of adequate growth(8-10)
    --  Reduced incidence of BPD(4,7,8,11)
    --  Reduced incidence of retinopathy of prematurity (ROP)(4,11,12)
    --  Reduced late-onset sepsis incidence and evaluations(4,11,12)
    --  Reduced risk of necrotizing enterocolitis (NEC)(4,7,13)
    --  Improved long-term outcomes such as neurodevelopment(14,15)
    --  Shortened stays in the neonatal intensive care unit (NICU)(7)
    --  Reduced hospital costs(2,3,7,16,17)
    --  Achievement of better growth in term infants recovering from surgery for
        single ventricle physiology (SVP)(18)

About Prolacta Bioscience
Prolacta Bioscience(®) is a global life sciences company dedicated to Advancing the Science of Human Milk(®) to improve health outcomes for critically ill and premature infants. More than 100,000 extremely premature infants(19) worldwide have benefited from Prolacta's human milk-based products, which have been evaluated in more than 20 peer-reviewed clinical studies. Hospitals adopting Prolacta's Exclusive Human Milk Diet realize up to a 3X return on investment.(3 )Operating the world's first pharmaceutical-grade human milk processing facilities, Prolacta maintains the industry's strictest quality and safety standards, with over 20 validated tests for screening and testing human milk. Prolacta's manufacturing process uses vat pasteurization to ensure pathogen inactivation while protecting nutritional composition and bioactivity. Learn more at www.prolacta.com, on X, Instagram, Facebook, and LinkedIn.

Media Contact:
Loren Kosmont
Lkosmont@prolacta.com
310-721-9444

References

    1. Galis R, Trif P, Mudura D, Mazela J, Daly MC, Kramer BW, Diggikar S.
       Association of fortification with human milk versus bovine milk-based
       fortifiers on short-term outcomes in preterm infants--a meta-analysis.
       Nutrients. 2024;16:910. https://doi.org/ 10.3390/nu16060910
    2. Data on file; hospital-provided outcomes analysis from 2019 to 2022.
    3. Swanson JR, Becker A, Fox J, et al. Implementing an exclusive human milk
       diet for preterm infants: real-world experience in diverse NICUs. BMC
       Pediatr. 2023;23(1). doi.org/10.1186/s12887-023-04047-5
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        Machado D, Marino BS, Chi A, Takao C, Gordon EE, Ashrafi A, Cacho N,
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    19. Data on file; estimated number of infants fed Prolacta's products from
        January 2007 to August 2023.

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SOURCE Prolacta Bioscience