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Association of Women’s Health, Obstetric, & Neonatal Nurses (AWHONN) encourages an exclusive human milk diet (EHMD) for vulnerable preterm infants in the neonatal intensive care unit (NICU)

Organization’s 2021 Policy Statement and Guidelines Recognize the Lifesaving Benefits, Reduced Hospitalization Costs, and the Reduction in Medical Co-Morbidities Associated with an All-Human Milk Diet for the Most Fragile Premature Infants

DUARTE, Calif., September 21, 2021 – Prolacta Bioscience®, the world’s leading hospital provider of 100% human milk-based vat pasteurized nutritional products for premature and critically ill infants, applauds the new evidenced-based policy and clinical guidance issued by the Association of Women’s Health, Obstetric, & Neonatal Nurses (AWHONN) regarding an exclusive human milk (non-cow/bovine-based) diet for premature infants in the NICU. Expanding on previous recommendations made in 2015, these new statements incorporate over a decade of clinical evidence, along with the expertise of the nation’s leading obstetric and neonatal nursing organization.

Published July 22, 2021, in Nursing for Women's Health, AWHONN’s 2021 official position and guidance regarding human milk in neonates supports the use of pasteurized donor human milk as the preferred substitute when mother’s own milk is not available. Calling human milk a lifesaving medical intervention for preterm infants, AWHONN elaborated that the benefits of an EHMD are shown to reduce the risk of necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), sepsis, mortality,1 and feeding intolerance, as well as lowering hospitalization costs.2

Further, AWHONN’s 2021 guidance titled “The Use of Human Milk During Parent-Newborn Separation,” also published in Nursing for Women’s Health, recommends the use of human milk fortifiers over cow milk-based fortifiers. AWHONN’s recommendation noted that vulnerable newborns who receive human milk and human milk fortifiers showed improved feeding tolerance, a faster advancement of human milk volumes, and an overall decrease in total number of parenteral nutrition days compared with newborns who received a combination of human milk, formula, and bovine/cow-based fortifiers.3

Citing expanded evidence, AWHONN’s 2021 position and guidance surrounding an EHMD strengthens its former statement titled “Breastfeeding” that was published in Nursing for Women's Health in 2015.4

“We welcome AWHONN’s recognition of the value of an EHMD and human milk-based fortifiers in critically ill and preterm infants,” said Prolacta’s Chief Medical Officer Melinda J. Elliott, MD, FAAP. Prolacta Bioscience is a member of the AWHONN Strategic Alliance, which aligns mutual goals between AWHONN and industry to advance nursing care for women and newborns. “AWHONN’s new guidance reinforces the short- and long-term benefits of an EHMD in reducing the serious health complications associated with premature infants. Proper nutrition plays a critical role in the development of these fragile patient populations.”

Compared to cow milk-based fortifiers, Prolacta’s 100% vat pasteurized human milk-based nutritional fortifiers, when used as part of an EHMD, have been clinically demonstrated in more than 20 peer-reviewed studies to:

  • Improve health outcomes, including:
  • Reduce feeding intolerance2
  • Lower mortality and morbidity8,12,13
  • Shorten stays in the neonatal intensive care unit (NICU)2
  • Reduce hospital costs2,14

For years, the risks associated with cow milk-derived fortifiers have made healthcare professionals cautious to begin early fortification. For example, fortification is often delayed in the NICU due to the risk of feeding intolerance associated with cow milk-derived fortifiers.9 Now, there is a growing body of clinical evidence demonstrating short- and long-term health and cognitive benefits for critically ill and preterm infants who are fortified early with an EHMD including Prolacta’s vat pasteurized products.6,10,15 Prolacta provides a recommended feeding protocol to all hospitals that use its 100% human milk fortifiers to ensure optimum health outcomes for the most fragile infants.

“AWHONN’s updated statements reflect the undeniable benefits of an EHMD for all infants, especially those born prematurely,” said AWHONN 2021 President Cyndy Krening, MS, CNS, RNC-OB, C-EFM. “Through guideline and policy statements, AWHONN provides lifesaving guidance to nurses working in obstetric and neonatal intensive care units (NICUs). We encourage hospital-based NICUs to explore the option of implementing an EHMD protocol to help improve the lives of their most vulnerable patients.”

AWHONN’s Position/Guidance

Find AWHONN’s 2021 updated official position and guidance here: “Breastfeeding and the Use of Human Milk.”

“The Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN) maintains that breastfeeding and the provision of expressed human milk are critical components to ensure the health and well-being of newborns, young children, and childbearing women. If a mother’s own milk is not available, pasteurized donor human milk is the preferred substitute and should be offered when available and medically appropriate before supplementation with infant (cow/bovine-based) formula.
“For infants born preterm or who require hospitalization/intensive care at birth, human milk is an essential lifesaving medical intervention.16 An exclusive human milk diet in low-birth-weight infants was shown to reduce the risk of severe intraventricular hemorrhage17; necrotizing enterocolitis, retinopathy of prematurity, bronchopulmonary dysplasia, sepsis, and mortality1; and feeding intolerance and hospitalization costs.2 Provisions should be made to support exclusive human milk diets, especially in vulnerable newborns.”

In addition to addressing the health benefits associated with an EHMD, the AWHONN 2021 guidelines emphasize the value of an EHMD for all infants prior to 6 months of age, along with:

  • Benefits of breastfeeding to childbearing women
  • Benefits of breastfeeding to public health
  • Measures to address disparity and equity with breastfeeding
  • Essential role of the nurse
  • Advocacy/legislative strategies to protect and promote human milk feeding and breastfeeding

AWHONN subsequent 2021 guidance titled “The Use of Human Milk During Parent-Newborn Separation” states:

“Ideally, the future of human milk feeding will include the customization of milk to meet the individual needs of the newborn. If fortification is warranted, providers should favor human milk fortifiers over bovine-based fortifiers. Such decisions may take into account the cost of human milk–based fortification and the fact that bovine fortifiers do not meet the requirements for exclusive human milk diets.”


The Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) is a 501(c)3 nonprofit membership organization. Its mission is to empower and support nurses caring for women, newborns, and their families through research, education, and advocacy. For more information, please contact Shannon Doolin at 202-261-2410 or

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 premature and critically ill infants. Prolacta's 100% human milk-based nutritional products have demonstrated, in more than 20 peer-reviewed studies, to improve health and reduce the most serious complications of prematurity. More than 70,000 premature infants have benefited from Prolacta’s nutritional products worldwide to date. [Data on file] 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 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 bioactivity of its human milk-based products. Prolacta is headquartered in Duarte, California, and can be found online at, on Twitter, Instagram, Facebook and LinkedIn.

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Media Contact:
Loren Kosmont


  1. 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
  2. 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
  3. Ghandehari, H., Lee, M.L., Rechtman, D.J. et al. An exclusive human milk-based diet in extremely premature infants reduces the probability of remaining on total parenteral nutrition: a reanalysis of the data. BMC Res Notes 5, 188 (2012).
  4. Association of Women's Health, Obstetric and Neonatal Nurses. Breastfeeding: AWHONN position statement. Nurs Womens Health. 2015;19(1) 83-88 doi:10.1111/1751-486X.12195
  5. 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
  6. 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
  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. 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
  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. 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.
  11. Huston, R.K., Markell, A.M., McCulley, E.A., Gardiner, S.K. and Sweeney, S.L. (2018), Improving Growth for Infants ≤1250 Grams Receiving an Exclusive Human Milk Diet. Nutrition in Clinical Practice, 33: 671-678.
  12. 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
  13. 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
  14. 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
  15. Hair AB, Bergner EM, Gollins LA, et al. Long-term outcomes at 2 and 5 years from the randomized controlled trial: human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in VLBW infants. Poster presented at: Pediatric Academic Societies Meeting. April 24 – May 1, 2019. Baltimore, MD.
  16. Spatz DL, Beyond BFHI: The Spatz 10-step and breastfeeding resource nurse model to improve human milk and breastfeeding outcomes J Perinat Neonatal Nurs, 32 (2) (2018), pp. 164-174, 10.1097/jpn.0000000000000339
  17. Carome, K., Rahman, A. & Parvez, B. Exclusive human milk diet reduces incidence of severe intraventricular hemorrhage in extremely low birth weight infants. J Perinatol 41, 535–543 (2021).