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Late-Onset Sepsis Reduced in Premature Infants Fed Prolacta’s 100% Human Milk-Based Fortifiers as Part of an Exclusive Human Milk Diet

Studies Showed Hospitals Effectively Reduced Both the Incidence of and Evaluations for Late-Onset Sepsis When Prolacta’s Fortifiers Were Used in Lieu of Cow Milk-Based Fortifiers

DUARTE, Calif., December 9, 2020 – Implementing Prolacta Bioscience’s products as part of an exclusive human milk diet (EHMD) reduced the incidence of and evaluations for late-onset sepsis among premature infants, according to clinical studies that compared Prolacta’s 100% human milk-based fortifiers to cow milk-based fortifiers.

Premature infants can face many life-threatening complications. Among the most prominent of these risks is late-onset sepsis, a dangerous systemic response to infection and a leading cause of mortality in neonatal intensive care units (NICUs). It is estimated that premature infants have up to a 26% chance of developing this serious complication.1 In addition to predisposing infants to other morbidities, and subsequent neurodevelopmental disabilities, sepsis significantly increases NICU costs.2

“We developed our human milk-based fortifiers to provide the precise nutrition that vulnerable infants need to have the best possible start in life,” said Melinda Elliott, M.D., FAAP, and chief medical officer of Prolacta. “We are encouraged by the reduction in late-onset sepsis incidence and evaluations observed with the use of Prolacta’s products as part of an EHMD. Less sepsis means less suffering for infants as well as resource savings for already budget-strapped NICUs.”

Minimizing the incidence of sepsis may include limiting premature infants’ exposure to interventions that have been shown to increase sepsis risk, such as central venous lines, extended parenteral feeding, and using cow milk-based fortifiers. Clinical evidence demonstrates that one way hospitals achieved this is with Prolacta’s 100% human milk-based fortifiers.

▪ A 2014 study showed that for every 10% increase in the volume of milk containing cow milk-based protein fed to preemies, the risk for sepsis increased by 17.9% (P < 0.001).3

▪ Similarly, a 2013 study showed the odds of sepsis decreased by 19% for every 10 mL/kg/day increase in the feeding dose of human milk in the critical first 28 days of life (P = 0.008).2

▪ By implementing Prolacta’s products as part of an EHMD, the University of Virginia (UVA) NICU achieved a 12.5% decrease (P = 0.06) in late-onset sepsis evaluations.4

▪ In 2016, researchers showed multiple clinical outcome improvements that suggest a direct association to the use of Prolacta’s products as part of an EHMD, including an 11.3% reduction in incidence of late-onset sepsis (P < 0.00001).5

About Prolacta Bioscience

Prolacta Bioscience Inc. is a privately held life sciences company dedicated to Advancing the Science of Human Milk®. Prolacta is the world’s leading hospital provider of 100% human milk-based nutritional products. These life-saving products have reduced complications and improved the health of more than 63,000 extremely premature infants globally.6 In addition, the company is exploring the therapeutic potential of human milk across a wide spectrum of human diseases, including applications for infants requiring surgery for congenital cardiac and gastrointestinal disorders. Operating the world’s first pharmaceutical-grade human milk processing facilities, Prolacta leads the industry with the highest quality and safety standards for the screening and testing of donor milk.

Media Contact:
Loren Kosmont


  1. El Manouni El Hassani S, Berkhout DJC, Niemarkt HJ, et al. Risk factors for late-onset sepsis in preterm infants: a multicenter case-control study. Neonatology. 2019;116(1):42-51. doi:10.1159/000497781
  2. Patel AL, Johnson TJ, Engstrom JL, et al. Impact of early human milk on sepsis and health-care costs in very low birth weight infants. J Perinatol. 2013;33(7):514-519. doi:10.1038/jp.2013.2
  3. 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
  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. 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
  6. Estimated number of premature infants fed Prolacta’s products from January 2007 to August 2020; data on file.