Prolacta Bioscience Introduces Its First Evidence-Based Feeding Protocol for an Exclusive Human Milk Diet in the NICU

Nutritional Guidance Sets Premature Infants on Track for Healthy Growth and Improved Outcomes

DUARTE, Calif., June 14, 2022 /PRNewswire/ -- 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 Protocol^TM 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 The protocol presents additional perspective on the standard of care in NICUs that can help premature infants avoid complications and reach key growth goals.

"This protocol provides best-practice guidance to members of the NICU team as we tailor nutrition to each infant's needs and risk factors," said Rangasamy Ramanathan, MD, professor of pediatrics, division chief, Division of Neonatal Medicine, LAC+USC Medical Center. "A standardized feeding approach for an EHMD with human milk-based products helps eliminate the uncertainty in meeting infants' protein goals to achieve adequate growth with fewer complications."

Prolacta's EHMD Protocol guides decision-making in the NICU as clinicians work to:

• Achieve healthier growth with fewer complications
• Fortify safely and confidently in the first week of life
• Tailor nutrition to each infant's individual needs and risk factors
• Account for variability of mother's own milk/unanalyzed donor milk
• Supplement for fat loss in tubing
• Meet protein goals while staying on-label

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,^2-4 lower hospital costs,^5,6 and significantly reduce the risk of complications and feeding intolerance associated with cow milk-based fortifiers.^2-5,7-9

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 Inversely, it is proven that delayed fortification leads to less-optimal results in critically ill, premature infants.¹⁰

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

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.^2,3,5,11 

"Prolacta's EHMD Protocol can reduce the incidence of comorbidities, support adequate growth, and improve mortality rates, offering groundbreaking benefits for this fragile patient population," said Melinda Elliott, MD, FAAP, and chief medical officer at Prolacta. "Even the most vulnerable infants born weighing less than 750 g have been shown to greatly benefit from an EHMD, giving them the best chance for a healthy, bright future."^{2-5,7-9,11-15}

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.

Prolacta's EHMD Protocol supports adequate growth with fewer complications as measured by increases in length, head circumference, and weight.¹¹ These gains lower the risk of long-term metabolic morbidities including obesity, diabetes, and cardiovascular disease.¹⁶ Research has shown that Prolacta's fortifiers, when used as part of an EHMD, support healthy body composition with improvements in lean body mass, normal total body fat, and adequate bone mineralization.¹⁶ Furthermore, for premature infants fed an EHMD, the benefits of appropriate nutrition extend to long-term neurocognitive development.¹⁴

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:

• Lower mortality and morbidity^3,5,8,17
• Reduce incidence of feeding intolerance^3,5
• Achieve adequate growth^2,11,17
• Reduce incidence of bronchopulmonary dysplasia (BPD)^2,4,5,8
• Reduce incidence of retinopathy of prematurity (ROP)^3,5,8
• Reduce late-onset sepsis incidence and evaluations⁸
• Reduce risk of necrotizing enterocolitis (NEC)^3,5,7,8,18                   
• Improve long-term outcomes such as neurodevelopment^14,19
• Shorten stays in the NICU⁵
• Reduce hospital costs^5,6

For a copy of Prolacta's EHMD Protocol, email [email protected].  

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 Bioactivity is thought to support infants' immunity, development, growth, and long-term health.²¹

Prolacta's 100% human milk-based nutritional products have the highest bioactivity in the human milk industry.¹ Prolacta's nutritional products are vat pasteurized using profiles defined by the U.S. Food and Drug Administration (FDA) to ensure pathogen inactivation and the highest level of safety while retaining as much of the natural bioactivity of the milk as possible.¹ Prolacta's vat pasteurized products retain higher bioactivity than products processed using other methods, including retort sterilization and ultra-high-temperature (UHT) processing.^22,23

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 online at www.prolacta.com, and on Twitter, Instagram, Facebook, and LinkedIn.         

*Estimated number of premature infants fed Prolacta's products from January 2007 to December 2021; data on file.

¹  Data on file.

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

³  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

⁴  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

⁵  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

⁶  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

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

⁸  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

⁹  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

¹⁰  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

¹¹  Hair 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

¹²  Hair AB, Lee ML. The effectiveness of an exclusive human milk diet in premature infants <750g birthweight. Presented at jENS September 2021.

¹³  Fleig 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

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  Hair 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.

¹⁶  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

¹⁷  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.

¹⁸  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: part II. Neonatology Today. 2020;15(10):3-8. doi: https://doi.org/10.51362/neonatology.today/202010151038

¹⁹  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

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

²¹  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. Nutrients. 2019;11(6):1307. doi:10.3390/nu11061307

²²  Lima HK, Wagner-Gillespie M, Perrin MT, Fogleman AD. Bacteria and bioactivity in Holder pasteurized and shelf-stable human milk products. Curr Dev Nutr. 2017;1(8):e001438. doi:10.3945/cdn.117.001438

²³  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

Loren Kosmont
[email protected]
310-721-9444

SOURCE Prolacta Bioscience