Preterm infant study finds proactive use of Prolact CR cream improves growth and reduces NICU costs

DUARTE, Calif., August 21, 2024 – Prolacta Bioscience^®, the world’s leading hospital provider of 100% human milk-based nutritional products for critically ill and premature infants, announced today that the journal Nutrients has published a study demonstrating that proactive use of its human milk-derived cream, Prolact CR^®, resulted in improved infant growth, decreased malnutrition rates, and reduced hospital costs.

The feeding protocol with proactive use of Prolact CR for very low birth weight (VLBW) infants demonstrated:

• Improved overall z-score weight change from birth to discharge within malnutrition severity (p = 0.0061). Specifically, severe malnutrition declined from 3.3% to 2.7%, and moderate malnutrition declined from 36.6% to 8.3%.¹
• Reduced need for higher-calorie (28 kcal/oz) fortifiers, decreasing from 43% to 14%.¹
• An average product cost savings of $2,968 per infant by using less human milk-based fortifiers.¹

The study, “Proactive Use of a Human Milk Fat Modular in the Neonatal Intensive Care Unit: A Standardized Feeding Protocol,” compared two groups of VLBW infants receiving Prolacta's Exclusive Human Milk Diet (EHMD). One group had Prolact CR added only if poor weight gain occurred, while the other received Prolact CR proactively when transitioning off parenteral nutrition and lipids were discontinued, providing an additional 2 kcal/oz  to account for the caloric reduction.

“Every NICU is continually looking to improve health outcomes and find cost savings. Through this study, we demonstrated that we were able to achieve both,” said the study’s lead author, Amanda Salley, MS, RD, CSP, LN, with UChicago Medicine/Advent Health, Hinsdale Hospital at the time of the study.

Made from 100% human milk cream, Prolact CR is a human milk caloric fortifier intended for use in the NICU, added to mother’s own milk or donor breast milk to provide essential calories and help premature infants achieve adequate growth without substantially increasing feeding volume. 

“These findings underscore the importance of optimizing protocols for each individual infant so we can improve their growth,” said Melinda Elliott, MD, chief medical officer at Prolacta Bioscience. “Not only do individualized feeding protocols support healthier growth, this approach means fewer complications for vulnerable infants and significant cost savings for hospitals.

About Prolacta’s Human Milk-Based Nutritional Products 

Available to hospitals since 2006, Prolacta’s human milk-based fortifiers changed the standard of care for critically ill, premature infants by providing a proven alternative to cow milk-based fortifiers in the NICU.^2,3,4

This year alone, human milk-based fortifiers and formulas have been used in more than 50% of the Level III and Level IV NICUs in the U.S.⁵ Compared to cow milk-based products, an EHMD with Prolacta’s 100% human milk-based nutritional fortifiers has been clinically proven in numerous clinical studies to:

• Lower mortality and morbidity^2,6
• Reduce risk of necrotizing enterocolitis (NEC)^4,7,8
• Reduce incidence of feeding intolerance⁷
• Achieve adequate growth^9,10,11
• Reduce incidence of bronchopulmonary dysplasia (BPD)^7,8,9,12
• Reduce incidence of retinopathy of prematurity (ROP)^7,8,12,13
• Reduce late-onset sepsis incidence^8,13 and evaluations¹²
• Improve long-term outcomes such as neurodevelopment^14,15
• Shorten stays in the NICU⁷
• Reduce hospital costs^7,16

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 infants¹⁷ worldwide have benefited from Prolacta's human milk-based products, which have been evaluated in more than 30 peer-reviewed clinical studies. 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. Connect with us at X, Instagram, Facebook, and LinkedIn.

Media Contact:
Loren Kosmont
Lkosmont@prolacta.com
310.721.9444

References

1. Salley A, Lee ML. Proactive use of a human milk fat modular in the neonatal intensive care unit: a standardized feeding protocol. Nutrients. 2024;16(8):1206. https://doi.org/10.3390/nu16081206
2. 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
3. Cristofalo EA, et al. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. December 2013. 163(6):1592-1595. doi: 10.1016/j.jpeds.2013.07.011
4. 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
5. Data on file; number of U.S. hospitals that used Prolacta's fortifiers and formulas in 2024.
6. 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
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. 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
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
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. Published 2013 Nov 13. doi:10.1186/1756-0500-6-459
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
13. 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
14. 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
15. 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
16. 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
17. Data on file; estimated number of premature infants fed Prolacta's products from January 2007 to August 2023.