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DUARTE, Calif., June 14, 2022 — Prolacta Bioscience®, the world’s leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, today announced the introduction of the first evidence-based feeding protocol for the use of an Exclusive Human Milk Diet including Prolacta’s products (Prolacta’s EHMD) in the neonatal intensive care unit (NICU). Prolacta’s EHMD ProtocolTM addresses the nutritional risks of late and inadequate nutrition facing low birth weight premature infants and is the first nutritional guidance issued for the use of the company’s human milk-based nutritional products.
Developed in conjunction with independent clinicians, registered dieticians, nurses, and neonatologists, Prolacta’s EHMD Protocol is backed by 15 years of clinical experience and more than 20 clinical studies.1 Data on file.
Prolacta’s EHMD Protocol guides decision-making in the NICU as clinicians work to:
Prolacta’s EHMD Protocol supports clinicians in delivering the optimal nutrients to fragile infants at the optimal time — helping as they work to achieve better health outcomes,2 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 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.2019.013 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 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 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 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 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.2019.013 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 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 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 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;12(10):663]. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134 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):562-567.e1. doi:10.1016/j.jpeds.2009.10.040
Over the past 15 years, more than 20 clinical studies involving more than 5,000 premature infants have shown that hospitals with the best outcomes followed similar feeding practices with the use of Prolacta’s fortifiers.1 Data on file. 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 corrections appear in Am J Clin Nutr. 2019;110(2):529 and Am J Clin Nutr. 2020;111(5):1112]. Am J Clin Nutr. 2018;108(1):108-116. doi:10.1093/ajcn/nqy067
An EHMD is achieved when 100% of the protein, fat, and carbohydrate in an infant’s diet are derived from human milk. An EHMD with Prolacta’s 100% human milk-based fortifiers, compared with the use of cow milk-based fortifiers or formula, is known to reduce the risk of severe complications and feeding intolerance in preterm infants.7 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
Fortify Early for the Best Outcomes
For years, the risks associated with cow milk-based fortifiers left healthcare professionals in the NICU cautious about starting fortification too early. With Prolacta’s EHMD Protocol, clinicians can safely begin fortification as early as the first week of an infant’s life, confident that issues such as feeding intolerance and other complications have been shown to be significantly reduced.2 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 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.2019.013 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 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. doi:10.1186/1756-0500-6-459
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
,3Lucas 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.2019.013
,4Delaney 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
,5Assad 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
,7Abrams 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
,8Hair 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;12(10):663]. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134
,9Sullivan 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
,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. doi:10.1186/1756-0500-6-459
,12Hair AB, Lee ML. The effectiveness of an exclusive human milk diet in premature infants <750g birthweight. Presented at jENS September 2021.
,13Fleig L, Hagan J, Lee ML, Abrams SA, Hawthorne KM, Hair AB. Growth outcomes of small for gestational age preterm infants before and after implementation of an exclusive human milk-based diet. J Perinatol. 2021;41(8):1859-1864. doi:10.1038/s41372-021-01082-x
,14Bergner 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
,15Hair AB, Patel A, Kiechl-Kohlendorfer, et al. Long-term neurodevelopmental outcomes of extremely preterm infants fed an exclusive human milk-based diet versus a bovine milk-based diet. Presented at PAS April 2019.
Proven Safety; Flexible Feeding Advancement
To help meet each patient’s unique needs, Prolacta’s EHMD Protocol is designed to provide flexible feeding advancement based on each premature infant’s weight, clinical status, and health risk factors.
Improved Short- and Long-Term Outcomes
Prolacta’s EHMD Protocol supports adequate growth with fewer complications as measured by increases in length, head circumference, and weight.11 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. doi:10.1186/1756-0500-6-459 Visuthranukul C, Abrams SA, Hawthorne KM, Hagan JL, Hair AB. Premature small for gestational age infants fed an exclusive human milk-based diet achieve catch-up growth without metabolic consequences at 2 years of age. Arch Dis Child Fetal Neonatal Ed. 2019;104(3):F242-F247. doi:10.1136/archdischild-2017-314547 Visuthranukul C, Abrams SA, Hawthorne KM, Hagan JL, Hair AB. Premature small for gestational age infants fed an exclusive human milk-based diet achieve catch-up growth without metabolic consequences at 2 years of age. Arch Dis Child Fetal Neonatal Ed. 2019;104(3):F242-F247. doi:10.1136/archdischild-2017-314547 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
Compared to cow milk-based fortifiers, an EHMD with Prolacta’s 100% human milk-based nutritional fortifiers has been clinically proven in more than 20 peer-reviewed 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.2019.013
,5Assad 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
,8Hair 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;12(10):663]. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134
,17Huston 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.
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.2019.013
,5Assad 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
,11Hair AB, Hawthorne KM, Chetta KE, et al. Human milk feeding supports adequate growth in infants ≤ 1250 grams birth weight. BMC Res Notes. 2013;6:459. doi:10.1186/1756-0500-6-459
,17Huston 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.
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
,4Delaney 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
,5Assad 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
,8Hair 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;12(10):663]. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134
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.2019.013
,5Assad 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
,8Hair 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;12(10):663]. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134
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;12(10):663]. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134
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.2019.013
,5Assad 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
,7Abrams 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
,8Hair 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;12(10):663]. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134
,18Lucas 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: part II. Neonatology Today. 2020;15(10):3-8. doi: https://doi.org/10.51362/neonatology.today/202010151038
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
,19Rahman 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
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
,6Ganapathy 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
For a copy of Prolacta’s EHMD Protocol, email info@prolacta.com.
About Human Milk-Based Products
The major difference between cow milk-based and human milk-based products is the composition — notably, the bioactive components that are unique to human milk. These include immunoglobulins, lactoferrin, milk fat globule membranes, and the wide spectrum of prebiotics known as human milk oligosaccharides (HMOs), which are not easily manufactured and thus are greatly decreased or missing from cow milk-based nutritional products.20 Ballard O, Morrow AL. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am. 2013;60(1):49-74. doi:10.1016/j.pcl.2012.10.002 Gila-Diaz A, Arribas SM, Algara A, Martín-Cabrejas MA, López de Pablo ÁL, Sáenz de Pipaón M, Ramiro-Cortijo D. A review of bioactive factors in human breastmilk: a focus on prematurity. Nutri-ents. 2019;11(6):1307. doi:10.3390/nu11061307
Prolacta’s 100% human milk-based nutritional products have the highest bioactivity in the human milk industry.1 Data on file. Data on file. Lima HK, Wagner-Gillespie M, Perrin MT, Fogleman AD. Bacteria and bioactivity in Holder pasteur-ized and shelf-stable human milk products. Curr Dev Nutr. 2017;1(8):e001438. doi:10.3945/cdn.117.001438 Meredith-Dennis L, Xu G, Goonatilleke E, Lebrilla CB, Underwood MA, Smilowitz JT. Composition and variation of macronutrients, immune proteins, and human milk oligosaccharides in human milk from nonprofit and commercial milk banks. J Hum Lact. 2018;34(1):120-129. doi:10.1177/0890334417710635
About Prolacta Bioscience
Prolacta Bioscience® Inc. is a privately held, global life sciences company dedicated to Advancing the Science of Human Milk® to improve the health of critically ill, premature infants. Prolacta's 100% human milk-based nutritional products have been evaluated in more than 20 clinical studies published in peer-reviewed journals. More than 80,000 premature infants have benefited from Prolacta’s nutritional products worldwide to date.* Established in 1999, Prolacta is the world’s leading provider of human milk-based nutritional products for hospital use and is also exploring the therapeutic potential of human milk across a wide spectrum of diseases. Prolacta maintains the industry’s strictest quality and safety standards for screening, testing, and processing human donor milk. Operating the world’s first pharmaceutical-grade human milk processing facilities, Prolacta uses vat pasteurization and a patented, FDA-reviewed manufacturing process to ensure pathogen inactivation while protecting the nutritional composition and bioactivity of its human milk-based products. Prolacta is a global company with headquarters in Duarte, California, and can be found on Twitter, Instagram, Facebook, and LinkedIn.
*Estimated number of premature infants fed Prolacta’s products from January 2007 to December 2021; data on file.
# # #
Media Contact:
Loren Kosmont
Lkosmont@prolacta.com
310-721-9444
References