Meta-Analysis Reveals Lifesaving Impact of
Human Milk-Based Fortifiers Over Cow Milk-Based
Fortifiers
DUARTE,
Calif., June 25, 2024 /PRNewswire/ -- An
independent study published in the journal Nutrients found a
50% reduction in mortality among preterm infants fed human
milk-based nutritional fortifiers. The meta-analysis assessed
short-term outcomes, comparing human milk-based fortifiers (HMBFs)
with cow milk-based fortifiers (CMBFs) in premature infants fed a
human milk diet of mother's own milk (MOM) or donor human milk
(DHM). The analysis comprised data from four clinical studies
involving 681 preterm infants born at <28 weeks of gestation,
with a birth weight of <1,500 g. Key findings:
- Use of a human milk diet with human milk-based fortifiers
reduced mortality by 50% compared to a diet with cow milk-based
fortifiers1 (p = 0.03).
- A trend toward reduced bronchopulmonary dysplasia (BPD)
with human milk fortifiers that approached statistical
significance1 (p = 0.05).
"The data associates bovine (cow) milk-based fortifiers with a
potentially increased risk of death in preterm infants, which makes
a reversal possibly necessary," notes the study, led by
Radu Galis, MD, neonatologist at
Emergency County Hospital Bihor in Romania. While the authors call for additional
research, they concluded: "The most important finding of our
analyses was the reduction in mortality across all four clinical
studies and data sets." The authors also note, "Bovine (cow) milk
products have been introduced into neonatal care without a safety
consideration or parental verification."
"The analysis underscores that human milk-based fortifiers can
save lives for the most vulnerable patients," said Melinda Elliott, MD, FAAP, practicing
neonatologist and chief medical officer at Prolacta Bioscience.
"Over 20 peer-reviewed studies and abundant real-world data from
around the globe demonstrate the clinical benefits of human
milk-based fortification for extremely premature infants."
This meta-analysis was independent of Prolacta Bioscience, the
world's leading hospital provider of 100% human milk-based
nutritional products for critically ill and premature infants.
Real-World Evidence Shows Improved Outcomes and Reduced Costs
of Human Milk-Derived Fortifiers
Extensive real-world data
affirm that adoption of an Exclusive Human Milk Diet (EHMD) enables
critical health improvements for premature infants and major cost
reductions for hospitals. Analysis of 2019-2022 data from more than
3,000 patients at 60+ U.S. hospitals found EHMD implementation
improved health outcomes and reduced costs, generating a 2.6X
dollar-for-dollar return on investment.2 Similarly, a
2023 peer-reviewed report found EHMD implementation resulted in a
3X dollar-for-dollar return on investment from a reduction in
comorbidities and shorter lengths of stay among very low birth
weight infants.3
The body of real-world evidence in support of HMBFs is
substantial. It has been clinically proven in more than 20
peer-reviewed clinical studies that compared to CMBFs, HMBFs when
used as part of an EHMD demonstrated:
- Lower mortality and morbidity4-6
- Reduced incidence of feeding intolerance7
- Achievement of adequate growth8-10
- Reduced incidence of BPD4,7,8,11
- Reduced incidence of retinopathy of prematurity
(ROP)4,11,12
- Reduced late-onset sepsis incidence and
evaluations4,11,12
- Reduced risk of necrotizing enterocolitis
(NEC)4,7,13
- Improved long-term outcomes such as
neurodevelopment14,15
- Shortened stays in the neonatal intensive care unit
(NICU)7
- Reduced hospital costs2,3,7,16,17
- Achievement of better growth in term infants recovering from
surgery for single ventricle physiology (SVP)18
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 infants19 worldwide have
benefited from Prolacta's human milk-based products, which have
been evaluated in more than 20 peer-reviewed clinical studies.
Hospitals adopting Prolacta's Exclusive Human Milk Diet realize up
to a 3X return on investment.3 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. Learn more at
www.prolacta.com, on X, Instagram, Facebook, and LinkedIn.
Media Contact:
Loren
Kosmont
Lkosmont@prolacta.com
310-721-9444
References
- Galis R, Trif P, Mudura D, Mazela J, Daly MC, Kramer BW,
Diggikar S. Association of fortification with human milk versus
bovine milk-based fortifiers on short-term outcomes in preterm
infants—a meta-analysis. Nutrients. 2024;16:910.
https://doi.org/ 10.3390/nu16060910
- Data on file; hospital-provided outcomes analysis from 2019 to
2022.
- 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.org/10.1186/s12887-023-04047-5
- 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 Dec;12 (10):663]. Breastfeed
Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134
- 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
- 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.e1.
doi:10.1016/j.jpeds.2013.07.011
- 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
- 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
- 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
- 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. Published 2013 Nov 13.
doi:10.1186/1756-0500-6-459
- 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
- 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 [published
correction appears in Am J Clin Nutr. 2019 Aug 1;110(2):529] [published correction appears
in Am J Clin Nutr. 2020 May
1;111(5):1112]. Am J Clin Nutr. 2018;108(1):108-116.
doi:10.1093/ajcn/nqy067
- 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
- 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
- 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
- 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
Feb;19(2):114-119. doi: 10.1089/bfm.2023.0163. Epub 2024 Jan 30.
PMID: 38294868.
- 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
- Blanco CL, Hair A, Justice LB, Roddy D, Bonagurio K, Williams
PK, Machado D, Marino BS, Chi A, Takao C, Gordon EE, Ashrafi A,
Cacho N, Pruetz JD, Costello JM, Cooper DS, & Cardiac Neonate
Nutrition Study Group. A randomized trial of an exclusive human
milk diet in neonates with single ventricle physiology. J
Pediatr. 2022;256: 105–112.
doi.org/10.1016/j.jpeds.2022.11.043
- Data on file; estimated number of infants fed Prolacta's
products from January 2007 to
August 2023.
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SOURCE Prolacta Bioscience