Human milk-based fortifiers cut mortality rate by 50% in preterm infants, independent study shows

DUARTE, Calif., June 25, 2024 – 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 fortifiers¹ (p = 0.03).
• A trend toward reduced bronchopulmonary dysplasia (BPD) with human milk fortifiers that approached statistical significance¹ (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, 5,6}
• Reduced incidence of feeding intolerance⁷
• Achievement of adequate growth^{8, 9, 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 infants¹⁹ 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
4. Hair AB, Peluso AM, Hawthorne KM, et al. Beyond necrotizing enterocolitis prevention: improving outcomes with an exclusive human milk-based diet [published correction appears in Breastfeed Med. 2017 Dec;12 (10):663]. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134
5. 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
6. Cristofalo EA, Schanler RJ, Blanco CL, et al. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. 2013;163(6):1592-1595.e1. doi:10.1016/j.jpeds.2013.07.011
7. Assad M, Elliott MJ, Abraham JH. Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet. J Perinatol. 2016;36(3):216-220. doi:10.1038/jp.2015.168
8. Huston R, Lee M, Rider E, et al. Early fortification of enteral feedings for infants <1250 grams birth weight receiving a human milk diet including human milk-based fortifier. J Neonatal Perinatal Med. 2020;13(2):215-221. doi:10.3233/NPM-190300
9. Huston RK, Markell AM, McCulley EA, Gardiner SK, Sweeney SL. Improving growth for infants ≤1250 grams receiving an exclusive human milk diet. Nutr Clin Pract. 2018;33(5):671-678. doi:10.1002/ncp.10054
10. Hair AB, Hawthorne KM, Chetta KE, Abrams SA. Human milk feeding supports adequate growth in infants ≤1250 grams birth weight. BMC Res Notes. 2013;6:459. Published 2013 Nov 13. doi:10.1186/1756-0500-6-459
11. Delaney Manthe E, Perks PH, Swanson JR. Team-based implementation of an exclusive human milk diet. Adv Neonatal Care. 2019;19(6):460-467. doi:10.1097/ANC.0000000000000676
12. O'Connor DL, Kiss A, Tomlinson C, et al. Nutrient enrichment of human milk with human and bovine milk-based fortifiers for infants born weighing <1250 g: a randomized clinical trial [published correction appears in Am J Clin Nutr. 2019 Aug 1;110(2):529] [published correction appears in Am J Clin Nutr. 2020 May 1;111(5):1112]. Am J Clin Nutr. 2018;108(1):108-116. doi:10.1093/ajcn/nqy067
13. Sullivan S, Schanler RJ, Kim JH, et al. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediatr. 2010;156(4):562-7.e1. doi:10.1016/j.jpeds.2009.10.040
14. Bergner EM, Shypailo R, Visuthranukul C, et al. Growth, body composition, and neurodevelopmental outcomes at 2 years among preterm infants fed an exclusive human milk diet in the neonatal intensive care unit: a pilot study. Breastfeed Med. 2020. 15(5):304-311. doi:10.1089/bfm.2019.0210
15. Rahman A, Kase J, Murray Y, et al. Neurodevelopmental outcome of extremely low birth weight infants fed an exclusive human milk diet is not affected by growth velocity. Breastfeed Med. 2020;15(6):362-369. doi:10.1089/bfm.2019.0214
16. Tetarbe M, Chang MR, Barton L, Cayabyab R, Ramanathan R. Economic and Clinical Impact of Using Human Milk-Derived Fortifier in Very Low Birth Weight Infants. Breastfeed Med. 2024 Feb;19(2):114-119. doi: 10.1089/bfm.2023.0163. Epub 2024 Jan 30. PMID: 38294868.
17. Ganapathy V, Hay JW, Kim JH. Costs of necrotizing enterocolitis and cost-effectiveness of exclusively human milk-based products in feeding extremely premature infants. Breastfeed Med. 2012;7(1):29-37. doi:10.1089/bfm.2011.0002
18. Blanco CL, Hair A, Justice LB, Roddy D, Bonagurio K, Williams PK, Machado D, Marino BS, Chi A, Takao C, Gordon EE, Ashrafi A, Cacho N, Pruetz JD, Costello JM, Cooper DS, & Cardiac Neonate Nutrition Study Group. A randomized trial of an exclusive human milk diet in neonates with single ventricle physiology. J Pediatr. 2022;256: 105–112. doi.org/10.1016/j.jpeds.2022.11.043
19. Data on file; estimated number of infants fed Prolacta’s products from January 2007 to August 2023.