DUARTE, Calif., March 17, 2021 /PRNewswire/ -- Four clinical
studies, including a randomized clinical trial, showed that an
exclusive human milk diet (EHMD) using Prolacta Bioscience's 100%
human milk-based fortifiers reduced the incidence and/or severity
of retinopathy of prematurity (ROP) in premature infants compared
to those fed cow milk-based fortifiers.
ROP is an eye disease that results in abnormal development of
retinal blood vessels and is a leading cause of decreased vision
and blindness in children worldwide, primarily affecting premature
infants.1,2 Severe ROP is a predictor of functional
disability for children,3 including a direct impact on
their neurodevelopment.4
"We are encouraged by the growing body of clinical evidence
proving the significant health benefits of Prolacta's products as
part of an EHMD and are especially encouraged by this data, which
shows reduction in the incidence and severity of ROP," said
Melinda Elliott, M.D., FAAP, and
chief medical officer of Prolacta. "Addressing premature infant
complications through nutrition in the neonatal intensive care unit
(NICU) means improved short- and long-term health benefits for each
infant affected, as well as reduced hospitalizations and costs for
all involved."
ROP is one of the comorbidities of prematurity that hospitals
worldwide are working to reduce. The incidence and/or severity of
this life-changing disease decrease when extremely premature
infants are nourished with Prolacta's products as part of an
EHMD.5-8
Clinical Evidence
- Results of a 2018 study showed an 84% relative reduction in the
incidence of severe ROP (P = 0.04) in preterm infants
receiving Prolacta's products as part of an EHMD when compared to
preterm infants < 1,250 g receiving mother's own milk/donor milk
with cow milk-based fortifiers.6
- Similarly, a 2016 study showed a 55% relative reduction in the
incidence of ROP (P < 0.001) in preterm infants ≤ 1,500 g
receiving Prolacta's fortifiers as part of an EHMD when compared to
preterm infants receiving cow milk-based
fortifiers.8
- By implementing Prolacta's products as part of an EHMD, a 2016
study showed multiple clinical outcome improvements, including a
42% relative reduction in the incidence of ROP (P = 0.003),
in preterm infants < 1,250 g.7
- The University of Virginia (UVA)
NICU achieved a 22% relative reduction in the incidence of ROP
(P = 0.054) after implementing Prolacta's products as part
of an EHMD in infants born ≤ 1,250 g.5
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 been evaluated in more than 20
clinical trials published in peer-reviewed journals. More than
63,000 premature infants have benefitted from Prolacta's
nutritional products worldwide to-date.9 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 human donor
milk. Operating the world's first pharmaceutical-grade human milk
processing facilities, Prolacta uses vat pasteurization and a
patented, FDA-reviewed manufacturing process to ensure pathogen
inactivation, while protecting the nutritional composition and
bioactivity of its human milk-based products.
Prolacta headquarter is located at Duarte, California, and can be found online at
www.prolacta.com, on Twitter, Instagram, Facebook and LinkedIn.
Media Contact:
Loren
Kosmont
Lkosmont@prolacta.com
310.721.9444
References
- Dutta S, Raghuveer T, Vinekar A, Dogra MR. Can we stop the
current epidemic of blindness from retinopathy of prematurity?
Indian Pediatr. 2016;53(Suppl 2):S80-S84.
- Kong L, Fry M, Al-Samarraie M, Gilbert C, Steinkuller PG. An
update on progress and the changing epidemiology of causes of
childhood blindness worldwide. J AAPOS. 2012;16(6):501-507.
doi:10.1016/j.jaapos.2012.09.004
- Raghuveer TS, Zackula R. Strategies to prevent severe
retinopathy of prematurity: a 2020 update and meta-analysis.
NeoReviews. 2020;21(4):e249-e263.
doi:10.1542/neo.21-4-e249
- Molloy CS, Anderson PJ, Anderson VA, Doyle LW. The long-term
outcome of extremely preterm (<28 weeks' gestational age)
infants with and without severe retinopathy of prematurity. J
Neuropsychol. 2016;10(2):276-294. doi:10.1111/jnp.12069
- 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 corrections appear in Am J Clin
Nutr. 2019;110(2):529 and Am J Clin Nutr.
2020;111(5):1112] Am J Clin Nutr. 2018;108(1):108-116.
doi:10.1093/ajcn/nqy067
- 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
- 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
- Estimated number of premature infants fed Prolacta's products
from January 2007 to August 2020; data on file.
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SOURCE Prolacta Bioscience