Study finds fewer cases of Necrotizing Enterocolitis in premature infants and cost savings after implementing an Exclusive Human Milk Diet

DUARTE, Calif., Feb. 4, 2025 – An independent study published in Advances in Neonatal Care found fewer cases of the potentially fatal intestinal disease necrotizing enterocolitis (NEC) among very low birth weight (VLBW) infants fed an Exclusive Human Milk Diet (EHMD), compared to those fed cow milk-based products. The research builds on the growing body of clinical evidence demonstrating that a 100% human milk-based feeding protocol reduces the risk of NEC in premature infants.^1,

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

^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

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):562-7.e1. doi:10.1016/j.jpeds.2009.10.040

The study, “Exclusive Human Milk Diets and the Reduction of Necrotizing Enterocolitis,” compared NEC incidence in VLBW infants before and after a neonatal intensive care unit (NICU) switched from a cow milk-based protocol to an EHMD. Researchers examined records of 201 preterm infants born before 32 weeks gestation weighing less than 1,250 g (2.75 lb). Of these, 105 infants received an EHMD, while 96 infants received the cow milk-based protocol. 

Key findings⁴

Harris L, Lewis S, Vardaman S. Exclusive human milk diets and the reduction of necrotizing enterocolitis. Adv Neonatal Care. 2024;24(5):400-407. doi:10.1097/ANC.0000000000001183

:

• 1% mortality rate of the EHMD group, compared to 6% of the cow milk-based (CMB) group 
• 4.8% NEC diagnosis of the EHMD group, compared to 10.55% of the CMB group
• Greater weight gain of the EHMD group during hospitalization, compared to the CMB group (P = < .05)  
• Approximately $868,000 cost savings after the initiation of an EHMD compared to the CMB protocol used the previous three years

“Very low birth weight infants should only receive bovine-based formula if the mother’s expressed breast milk or pasteurized donor milk is not available,” notes the study, led by Lydia Harris, DNP, RN, of Memorial Hospital in Savannah, Georgia. “Diets of bovine-based formula should be the last choice of feeding for very low birth weight neonates.”

The Harris study contributes to the literature demonstrating that an EHMD decreases the incidence of NEC and other neonatal morbidities in the most vulnerable preterm infants — those born weighing 1,250 g or less.^1,

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

^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,

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):562-7.e1. doi:10.1016/j.jpeds.2009.10.040

^5,

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

^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,

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

^8,

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

⁹

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

NEC primarily affects premature or sick newborns, causing inflammation and death of intestinal tissue. Severe cases can lead to fatal infection or intestinal perforation requiring surgery. In the very smallest preemies, the death rate from NEC is as high as 50%.¹⁰

Alganabi M, Lee C, Bindi E, Li B, Pierro A. Recent advances in understanding necrotizing enterocolitis. F1000Res. 2019;8:F1000 Faculty Rev-107. doi:10.12688/f1000research.17228.1 PMID: 30740215; PMCID: PMC6348433.

“The Harris research findings underscore what numerous studies have found: Consistent implementation of a human milk-based feeding protocol not only improves outcomes for premature infants, but it’s also financially prudent for hospitals due to fewer complications in this vulnerable infant population,”^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

^11,

Tetarbe M, Chang MR, Barton L, Cayabyab R, Ramanathan R. Economic and clinical impact of using human milk-derived fortifier in very low birth weight infants. Breastfeed Med. 2024;19(2):114-119. doi:10.1089/bfm.2023.0163 PMID: 38294868.

^12,

Swanson JR, Becker A, Fox J, et al. Implementing an exclusive human milk diet for preterm infants: real-world experience in diverse NICUs. BMC Pediatr. 2023;23(1). doi:10.1186/s12887-023-04047-5

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

said Melinda Elliott, MD, FAAP, chief medical officer at Prolacta. 

The authors concluded: Education regarding the importance of an EHMD protocol is a necessity for the entire multidisciplinary health care team.⁴

Harris L, Lewis S, Vardaman S. Exclusive human milk diets and the reduction of necrotizing enterocolitis. Adv Neonatal Care. 2024;24(5):400-407. doi:10.1097/ANC.0000000000001183

The Harris study was independent of Prolacta Bioscience, the world’s leading hospital provider of 100% human milk-based nutritional products for critically ill and premature infants.

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 infants worldwide¹⁴

Data on file; estimated number of premature infants fed Prolacta's products from January 2007 to August 2023

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. 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
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. 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):562-7.e1. doi:10.1016/j.jpeds.2009.10.040
4. Harris L, Lewis S, Vardaman S. Exclusive human milk diets and the reduction of necrotizing enterocolitis. Adv Neonatal Care. 2024;24(5):400-407. doi:10.1097/ANC.0000000000001183
5. 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
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. 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
8. 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
9. 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
10. Alganabi M, Lee C, Bindi E, Li B, Pierro A. Recent advances in understanding necrotizing enterocolitis. F1000Res. 2019;8:F1000 Faculty Rev-107. doi:10.12688/f1000research.17228.1 PMID: 30740215; PMCID: PMC6348433.
11. Tetarbe M, Chang MR, Barton L, Cayabyab R, Ramanathan R. Economic and clinical impact of using human milk-derived fortifier in very low birth weight infants. Breastfeed Med. 2024;19(2):114-119. doi:10.1089/bfm.2023.0163 PMID: 38294868.
12. Swanson JR, Becker A, Fox J, et al. Implementing an exclusive human milk diet for preterm infants: real-world experience in diverse NICUs. BMC Pediatr. 2023;23(1). doi:10.1186/s12887-023-04047-5
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. Data on file; estimated number of premature infants fed Prolacta’s products from January 2007 to August 2023.