New Study Finds Improved Long-Term Neurodevelopmental Outcomes for Extremely Premature Infants Fed Prolacta's Exclusive Human Milk Diet (EHMD)

Preterm Infants Who Received Prolacta's 100% Human Milk-Based Fortifiers as Part of an EHMD in the NICU Had Improved Developmental Outcomes at Age 2, Findings Show       

DUARTE, Calif., Nov. 9, 2022 /PRNewswire/ -- Prolacta Bioscience^®, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, announced today the publication of a journal article that showed improved long-term neurodevelopmental outcomes in extremely premature infants who received Prolacta's 100% human milk-based fortifiers as part of an Exclusive Human Milk Diet (Prolacta's EHMD), compared with infants fed a cow milk-based diet in the neonatal intensive care unit (NICU).¹ 

Published in the Journal of Perinatology, the retrospective, multicenter cohort study, "Neurodevelopmental Outcomes of Extremely Preterm Infants Fed an Exclusive Human Milk-Based Diet Versus a Mixed Human Milk + Bovine Milk-Based Diet: a Multi-Center Study," examined data from 252 premature infants with a birth weight of less than or equal to 1,250 grams. Researchers assessed the infants' development using the Bayley Scales of Infant Development III (BSID-III), the standard measure of infants' neurological development. They found that infants fed Prolacta's EHMD in the neonatal intensive care unit (NICU) had significantly higher BSID-III cognitive scores and a trend toward improved language scores at a corrected age of 18 to 22 months.¹ 

"This long-term outcome study demonstrated promising post-discharge cognitive scores for preterm infants fed an EHMD," said lead author Amy B. Hair, MD, of the Section of Neonatology, Department of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, Houston, Texas. "This data is further evidence that human milk nutrition and fortification are both imperative for long-term brain development in infants born prematurely."

After adjusting for birth weight, gender, and the presence of necrotizing enterocolitis (NEC) — a serious and often life-threatening intestinal disease that affects neurological development — preterm infants who received Prolacta's EHMD, compared with those fed a cow milk-based diet (CMD), had: 

• Significantly higher BSID-III cognitive scores (96.5 ± 15.1 vs. 89.6 ± 14.1; P = 0.001)
• Improved language scores, with a difference that approached significance (85.5 ± 15.0 vs. 82.2 ± 14.1; adjusted P = 0.09)

"Infants without NEC also had higher BSID-III scores if they received an EHMD vs. a cow milk-based diet," noted Hair. "This suggests additional mechanisms involved aside from NEC prevention."

Nutritional management of extremely low birth weight (ELBW) infants in their first days and weeks of life has potentially long-term implications. During this crucial time, rapid growth and development of vital organs, including the brain and lungs, occurs.² Furthermore, early fortification — within the very first days of life — with 100% human milk-based fortifiers is safe and proven to help achieve healthy neonatal growth in the NICU.³ 

"Studies such as this one continue to show that human milk and human milk-based fortifiers are critical for these fragile infants," explained Melinda Elliott, MD, FAAP, chief medical officer at Prolacta, and a practicing neonatologist. "The findings of this neurodevelopment study are especially significant as they demonstrate that human milk-based nutrition helps to give preterm infants the best chance at a bright future."

About Human Milk-Based Nutritional Products

The major difference between cow milk-based and human milk-based nutritional products is the composition — notably, the bioactive components that are unique to human milk. These include immunoglobulins, lactoferrin, milk fat globule membrane, and the wide spectrum of prebiotics known as human milk oligosaccharides (HMOs), which are not easily manufactured and thus are greatly decreased or missing from cow milk-based nutritional products.⁴ Bioactivity is thought to support infants' immunity, development, growth, and long-term health.⁵  

Prolacta's 100% human milk-based nutritional products have the highest bioactivity in the human milk industry.⁶ Prolacta's nutritional products are vat pasteurized using profiles defined by the U.S. Food and Drug Administration (FDA) to ensure pathogen inactivation and the highest level of safety while retaining as much of the natural bioactivity of the milk as possible.⁷ Prolacta's vat pasteurized products retain higher bioactivity than products processed using other methods, including retort sterilization and ultra-high-temperature (UHT) processing.^6,8,9

 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 80,000 premature infants have benefited from Prolacta's nutritional products worldwide to date.¹⁰  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 is a global company with headquarters in Duarte, California, and can be found online at www.prolacta.com, on Twitter, Instagram, Facebook, and LinkedIn. 

Media Contact:
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References

1. Hair AB, Patel AL, Kiechl-Kohlendorfer U, et al. Neurodevelopmental outcomes of extremely preterm infants fed an exclusive human milk-based diet versus a bovine milk-based diet: a multi-center study. J Perinatol. Published online September 28, 2022. doi.org/10.1038/s41372-022-01513-3
2. 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
3. Huston RK, Lee ML, Rider ED, 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
4. Ballard O, Morrow AL. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am. 2013 Feb;60(1):49-74. doi: 10.1016/j.pcl.2012.10.002. PMID: 23178060; PMCID: PMC3586783.
5. Gila-Diaz A, Arribas SM, Algara A, Martín-Cabrejas MA, López de Pablo ÁL, Sáenz de Pipaón M, Ramiro-Cortijo D. A review of bioactive factors in human breastmilk: a focus on prematurity. Nutrients. 2019;11(6):1307. doi:10.3390/nu11061307
6. Liang N, Koh J, Kim BJ, Ozturk G, Barile D, Dallas DC. Structural and functional changes of bioactive proteins in donor human milk treated by vat-pasteurization, retort sterilization, ultra-high-temperature sterilization, freeze-thawing and homogenization. Front. Nutr. 2022;9. https://doi.org/10.3389/fnut.2022.926814
7. Data on file.
8. Meredith-Dennis L, Xu G, Goonatilleke E, Lebrilla CB, Underwood MA, Smilowitz JT. Composition and variation of macronutrients, immune proteins, and human milk oligosaccharides in human milk from nonprofit and commercial milk banks. J Hum Lact. 2018;34(1):120-129. doi:10.1177/0890334417710635
9. Lima HK, Wagner-Gillespie M, Perrin MT, Fogleman AD. Bacteria and bioactivity in Holder pasteurized and shelf-stable human milk products. Curr Dev Nutr. 2017;1(8):e001438. doi:10.3945/cdn.117.001438
10. Data on file; Estimated number of premature infants fed Prolacta's products from January 2007 to December 2021.

SOURCE Prolacta Bioscience