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DUARTE, Calif., September 24, 2024 – Prolacta Bioscience® today announced a significant milestone in premature infant nutrition. The company's human milk-based nutritional products have been used by more than 50% of Level III and Level IV neonatal intensive care units (NICUs) in the U.S. in 2024 to care for the most vulnerable premature infants – those born weighing less than 1250 g (2.75 lb).1 Data on file; number of U.S. hospitals that used Prolacta's fortifiers and formulas in 2024.
Over the past 17 years, Prolacta's 100% human milk-based nutritional products (made from donor breast milk) have become an option, over the use of cow milk-based nutrition, for premature infants in the NICU born weighing less than 1250 g.
The announcement comes during NICU Awareness Month, when professional and parent organizations are raising awareness of the nutritional standards in NICUs. Leading advocates for premature infants and their families support the adoption of human milk-based nutrition in the NICU, including: the National Black Nurses Association, Association of Women's Health, Obstetric and Neonatal Nurses, NICU Parent Network, Project NICU, and Once Upon a Preemie, Inc.
"The use of Prolacta's fortifiers and formulas in NICUs across the country represents a significant advancement in neonatal care and recognition of the vital role that human milk-based nutrition plays in the survival and long-term health of extremely premature infants," said Melinda Elliott, MD, FAAP, practicing neonatologist and chief medical officer for Prolacta.
One in 10 babies are born prematurely and nearly 1 million die each year worldwide, according to the World Health Organization.2 World Health Organization. Born too soon: decade of action on preterm birth. May 9, 2023. Accessed September 16, 2024. https://www.who.int/publications/i/item/9789240073890 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
A growing body of clinical evidence demonstrates the short- and long-term health benefits to critically ill, premature infants. Compared to cow milk-based products, an Exclusive Human Milk Diet (EHMD) with Prolacta's 100% human milk-based nutritional fortifiers, has been clinically proven in numerous clinical studies to:
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
5Abrams 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
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
7,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
8Sullivan 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):562-567.e1. doi:10.1016/j.jpeds.2009.10.040
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
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
10,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
11Hair 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
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
7,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
9,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
12Delaney 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
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
7,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
12,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
13O'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
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
13O'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
and evaluations12Delaney 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
Hair AB, Patel AL, Kiechl-Kohlendorfer U, et al. Neurodevelopmental outcomes of extremely preterm infants fed an exclusive human milk-based diet versus a mixed human milk + bovine milk-based diet: a multi-center study. J Perinatol. 2022;42(11):1485-1488. doi: 10.1038/s41372-022-01513-3
15Bergner 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
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
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
16Ganapathy 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
NICU Awareness Month is celebrated every September to raise awareness for the critical-care NICUs that care for premature and medically fragile newborns. For more information about Prolacta Bioscience, visit prolacta.com.
About Prolacta Bioscience Data on file; estimated number of premature infants fed Prolacta's products from January 2007 to August 2023.
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 worldwide17
Media Contact:
Loren Kosmont
Lkosmont@prolacta.com
310.721.9444
References