Resources & Evidence Contact us

Independent, head-to-head study shows significant health benefits of early fortification associated with Prolacta Bioscience’s 100% human milk-based fortifiers compared to cow milk-based fortifiers for premature infants

Study Finds Prolacta’s Fortifiers as Part of Exclusive Human Milk Diet (EHMD) Reduce Comorbidities and Shorten Length of NICU Stay; Benefits Help to Offset Upfront Costs

DUARTE, Calif., March 29, 2022 – An independent, head-to-head study from Neuburg, Germany, shows extremely low birth weight preterm infants fed Prolacta Bioscience® 100% human milk-based fortifiers (HMBF) as part of an Exclusive Human Milk Diet (EHMD) had reduced incidences of life-threatening comorbidities and experienced shorter stays in the neonatal intensive care unit (NICU), compared to those fed cow/bovine milk-based fortifiers (CMBF), offsetting the higher therapeutic costs of HMBF.1

The study, “Nutrition of Infants with Very Low Birth Weight Using Human and Bovine Based Milk Fortifier: Benefits and Costs,” was published in Neonatal and Pediatric Medicine and is the first head-to-head clinical trial of nutritional fortifiers conducted within Germany’s national health care system. The findings corroborate the results from more than 20 peer-reviewed studies demonstrating the benefits of Prolacta’s 100% human milk-based fortifiers, compared to cow-milk based fortifiers.2-15

The study compared whether preterm infants benefited from Prolacta’s human milk-based fortifier supplementation compared to cow/bovine milk-based fortifiers and whether the higher purchase costs were economically viable for hospitals. It found that preterm infants tolerate human milk-based fortifiers significantly better than bovine-based fortifiers, and while the human milk fortifiers entail higher therapeutic costs, they are offset by shorter in-hospital stays and fewer morbidities.

About the Study

The objective of the independent study was twofold:

  1. To determine whether extremely low birth weight preterm infants benefit from a HMBF compared to CMBF regarding food tolerance and common comorbidities of prematurity
  2. To evaluate whether the higher purchase costs associated with HMBFs are economically viable for Germany’s hospital NICUs

The study included 23 preterm infants of < 32 + 0 gestational weeks, born weighing less than 1,000 g (2.2 Ibs), admitted to the NICU at KJF Klinik St. Elisabeth, Neuburg an der Donau, Germany, between January 2019 and December 2020.1 The study allowed parents to choose between HMBF or CMBF supplementation; there were no other differences in the remaining nutrition and care.

Reduced Incidence of Life-Threatening Comorbidities

Based on the total number of events observed in the study, typical morbidities in the HMBF group were significantly less frequent (30%) than in the CMBF group (77%, P = 0.04). Due to the small sample size, individual comorbidities did not reach statistical significance. All comorbidities were higher in the CMBF group. As such, the study concluded the group of infants fed Prolacta’s human milk-based fortifier had significantly fewer preterm neonate morbidities over the entire clinical course compared with preterm infants given the cow milk-based fortifier.

Additionally, fecal calprotectin values in the stools of preterm infants – a marker for gastrointestinal tract inflammation – were significantly lower in the HMBF group than the CMBF group at days 35 (P = 0.02) and 42 (P = 0.03), suggesting improved gastrointestinal tolerance and reduced inflammation.1 Even though the HMBF group was smaller at birth, weight gain was as good as the CMBF group and resulted in fewer comorbidities.1

Reduced Length of Stay and Hospital Revenue Gains

The study reported that preterm infants given HMBF were discharged from the hospital a median of 75.5 days versus 80 days in the CMBF group. This resulted in a revenue gain of €5958.20 ($6,758.65 USD) per patient in the HMBF group. Making the same calculation for the CMBF group, this resulted in a per-patient revenue loss of €346.00 ($392.48 USD)‚ respectively.1

Likely due to the small number of comorbidities throughout the study, the revenue gain in the HMBF group was negated by the cost of the fortifier. Larger centers with higher case numbers may see a distinct economic advantage due to earlier discharge of preterm infants and decreased morbidities. Furthermore, earlier discharge creates additional capacity in NICUs, resulting in a positive impact on cost-effectiveness.

“The German study reaffirms, in a head-to-head trial, that not only is early fortification with human milk fortifiers better tolerated by the smallest neonates, but it is also the key to achieving healthy growth and reduced complications among these infants,” said Melinda Elliott, MD, chief medical officer at Prolacta and a practicing neonatologist. “Human milk is a complex, dynamic bioactive fluid with a myriad of compounds that make it the preferred nutrition for extremely low birth weight preterm infants to support their immunity, growth, neurodevelopment, and overall long-term health. The resulting benefit of Prolacta’s fortifiers, as part of an EHMD, to preterm infant health and the reductions in the cost of care, as demonstrated in this study, are being replicated worldwide by institutions using Prolacta’s feeding protocol in the first days of life.”15

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 membrane, 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.16 Bioactivity is thought to support infants’ immunity, development, growth, and long-term health.17

Prolacta’s 100% human milk-based nutritional products have the highest bioactivity in the human milk industry.15 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.15 Prolacta's vat pasteurized products retain higher bioactivity than products processed using other methods, including retort sterilization and ultra-high-temperature (UHT) processing.18,19

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, U.S. Food and Drug Administration-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, 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


  1. Osmanova M, Müller MJ, Habisch B, Hippe A, Seeliger S. Nutrition of infants with very low birth weight using human and bovine based milk fortifier: benefits and costs. Neonat Pediatr Med. 2021;S10:003.
  2. 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
  3. 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
  4. 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. [Epub ahead of print]. doi:10.1089/bfm.2019.0133
  5. 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
  6. 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
  7. 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. Am J Clin Nutr. 2018;108(1):108-116. doi:10.1093/ajcn/nqy067. Published corrections appear in Am J Clin Nutr. 2019;110(2):529. doi:10.1093/ajcn/nqz091 and Am J Clin Nutr. 2020;111(5):1112. doi:10.1093/ajcn/nqaa042
  8. 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
  9. 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
  10. 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
  11. Cristofalo EA, et al. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature nfants. J Pediatr. December 2013. 163(6):1592-1595. doi: 10.1016/j.jpeds.2013.07.011.
  12. 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
  13. 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
  14. 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
  15. Internal data
  16. 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
  17. 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
  18. 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
  19. 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