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Turning to nutrition to help address the complications of prematurity

Since 2012, the American Academy of Pediatrics has recommended human milk as the primary source of nutrition for premature babies, with appropriate fortification for those born weighing < 1,500 g.1

Academy of Pediatrics. Breastfeeding and the use of human milk. Section on Breastfeeding. Pediatrics. 2012;129(3):e827-e841. doi:10.1542/peds.2011-3552

Fortification with human milk-based fortifiers is the only way to ensure these medically fragile infants receive an exclusive human milk diet (EHMD).

Prolacta products used as a part of that EHMD,2

An exclusive human milk diet (EHMD) is achieved when 100% of the protein, fat, and carbohydrates in an infant’s diet are derived from human milk; this diet includes Prolacta’s 100% human milk–based fortifiers.

as compared to cow’s milk-based fortifiers, have been shown in clinical studies to benefit critically ill, premature infants in the NICU weighing ≤1250 g at birth in many ways including to:

Clinical evidence
Clinical evidence

Getting the most out of an EHMD

Clinical value

Learn about cost savings, complication reductions and health outcomes associated with our products

Clinical evidence

Read peer-reviewed studies and clinical results

Peer support

Gain insights from fellow neonatologists, nurses and dietitians

Leading the human milk industry in quality and safety

nursing

First and only pharmaceutical-grade manufacturing facilities for the testing and processing of human milk

vile

Exceed food-product industry requirements by following stringent quality and safety standards based on those for the human plasma and blood industry in the U.S.

FDA-regulated lab processes

Our human milk laboratory and manufacturing processes are regulated by the U.S. Food and Drug Administration (FDA).

All Prolacta nutritional products are pasteurised to ensure the highest quality and safety, using time and temperature profiles defined by the FDA in its Pasteurized Milk Ordinance (PMO) to destroy pathogenic viruses and bacteria.

While there are other pasteurisation and sterilisation processes used in the human milk banking industry, only products manufactured with our pasteurisation process are clinically shown to improve health and reduce complications when used as part of an EHMD in the neonatal intensive care unit (NICU). There is no clinical data showing similar results using products processed by any other method.

Benefits of HMOs

Prolacta’s 100% human milk-based nutritional products contain a wide spectrum of human milk oligosaccharides (HMOs).13

Barile D, Lebrilla CB, German B, Rechtman DJ, Lee ML. Oligosaccharide prebiotics present in a breast milk based human milk fortifier. Presented at: Hot Topics in Neonatology. Washington DC. December 2008.

The immunity, prebiotic and gut maturation benefits that HMOs promote may have a role in the health outcomes attributed to an EHMD, including Prolacta’s products.14

Moukarzel S, Bode L. Human milk oligosaccharides and the preterm infant: a journey in sickness and in health. Clin Perinatol. 2017;44(1):193-207. doi:10.1016/j.clp.2016.11.014

To learn more

Improving health outcomes for premature infants

For more than two decades, we have been advancing the science of human milk to improve the health of premature, critically ill infants worldwide.

  • The clinical benefits of our products have been demonstrated in 20+ clinical trials studying 5000+ infants
  • Globally, more than 100,000 premature infants have benefited from our proven human milk-based nutritional products*

Preterm nutrition products

A cost-effective solution

When used as part of an EHMD, our nutritional products are clinically proven to increase survival and reduce the overall cost of care compared to cow’s milk-based fortifiers or preterm formula in extremely premature infants.5

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

,6

Hair AB, Peluso AM, Hawthorne KM, et al. Beyond necrotizing enterocolitis prevention: improving outcomes with an exclusive human milk-based diet. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134. Published correction appears in Breastfeed Med. 2017;12(10):663. doi:10.1089/bfm.2015.0134.correx

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*Estimated number of premature infants fed Prolacta’s products from January 2007 to August 2023; data on file.

Citations

1 Academy of Pediatrics. Breastfeeding and the use of human milk. Section on Breastfeeding. Pediatrics. 2012;129(3):e827-e841. doi:10.1542/peds.2011-3552

2 An exclusive human milk diet (EHMD) is achieved when 100% of the protein, fat, and carbohydrates in an infant’s diet are derived from human milk; this diet includes Prolacta’s 100% human milk–based fortifiers.

3 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. doi:10.1016/j.jpeds.2009.10.040

4 Cristofalo EA, Schanler RJ, Blanco CL, et al. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. 2013;163(6):1592-1595. doi:10.1016/j.jpeds.2013.07.011

5 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

6 Hair AB, Peluso AM, Hawthorne KM, et al. Beyond necrotizing enterocolitis prevention: improving outcomes with an exclusive human milk-based diet. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134. Published correction appears in Breastfeed Med. 2017;12(10):663. doi:10.1089/bfm.2015.0134.correx

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 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

9 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

10 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

11 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

12 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

13 Barile D, Lebrilla CB, German B, Rechtman DJ, Lee ML. Oligosaccharide prebiotics present in a breast milk based human milk fortifier. Presented at: Hot Topics in Neonatology. Washington DC. December 2008.

14 Moukarzel S, Bode L. Human milk oligosaccharides and the preterm infant: a journey in sickness and in health. Clin Perinatol. 2017;44(1):193-207. doi:10.1016/j.clp.2016.11.014

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