Study shows exclusive human milk diet benefits term infants post-gastroschisis repair; Data to be presented at ESPGHAN 2024 meeting

DUARTE, Calif., May 15, 2024 – Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, announced today that data demonstrating the benefits of Prolacta’s Exclusive Human Milk Diet (EHMD) for term infants recovering from gastroschisis repair surgery will be presented at the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) meeting in Milan, Italy, taking place May 15-18.

Gastroschisis is a birth defect in which the intestines, and sometimes other organs, protrude through a hole in the abdominal wall. Infants recovering from gastroschisis repair, especially those with complex disease and comorbidities (e.g., heart or lung disease), require high macronutrient intake for optimal growth.¹ Clinicians are increasingly addressing this nutritional need through human milk fortification, which means adding a fortifier to mother's own milk or donor milk to provide additional calories and protein. Until recently, fortification was primarily with cow milk-based fortifiers or formula. These fortifiers have been associated with feeding intolerance and necrotizing enterocolitis (NEC) in preterm infants.^{2, 3, 4}

The ESPGHAN poster presentation “Human Milk-Based Fortifiers Associated With Improved Growth and Shorter Time to Full Enteral Feeds in Term Infants After Gastroschisis Repair” includes data from a case-control study showing:

• Term infants who received an EHMD with Prolacta’s human milk-based fortifier formulated for term infants achieved full enteral feeds 30 days sooner than infants who received cow milk-based fortifiers or formula (adjusted p = 0.004).
• The EHMD-fed cohort also experienced higher weight gain velocity (adjusted p = 0.049) and less NEC, with no adverse events reported.

"Term infants who require surgery often experience poor growth and significant morbidities when a cow milk-based nutritional fortifier is used," said study lead author Dr. Heidi Karpen of the Emory University School of Medicine. "Safe and early postsurgical fortification with an EHMD helps address the specific feeding challenges impacting these infants. It also supports growth and decreases the risk of NEC, which may translate into improved long-term neurodevelopmental outcomes."

"This pioneering study for infants with gastroschisis reaffirms the critical importance of optimal nutrition for the growth and health of medically fragile infants," noted Melinda Elliott, MD, FAAP, practicing neonatologist and chief medical officer for Prolacta. “It is well-established in the medical community and in hospitals across the country that Prolacta's EHMD is beneficial for extremely low birth weight premature infants. This data demonstrates that the benefits extend to term infants who require surgery for gastroschisis repair.”

The ESPGHAN annual meeting is at the forefront of education provision and knowledge exchange. To register for the ESPGHAN meeting, click here.

About Prolacta’s Human Milk-Based Nutritional Products  

Available to hospitals since 2006, Prolacta’s human milk-based fortifiers changed the standard of care for critically ill, premature infants by providing a proven alternative to cow milk-based fortifiers in the NICU.^{4, 5, 6} The naturally occurring bioactive components in human milk are thought to support infants’ immunity, development, growth, and long-term health.⁷

Prolacta’s products have the highest bioactivity in the human milk industry⁸ and are clinically proven to significantly boost human milk bioactive proteins and antioxidant activity.⁹ The company’s proprietary processing ensures pathogen inactivation and the highest level of safety while retaining as much of the natural bioactivity of the milk as possible, compared to other human milk processing methods.^{8, 10,11}

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. As the world’s leading provider of human milk-based nutritional products for hospitals, Prolacta has touched the lives of more than 100,000 premature infants worldwide.¹² Prolacta's human milk-based products have been evaluated in more than 20 peer-reviewed clinical studies, and hospitals adopting Prolacta’s Exclusive Human Milk Diet realize up to a 3X dollar-for-dollar return on investment.¹³ 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

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2. 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
3. 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
4. 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
5. 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
6. Cristofalo EA, et al. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. December 2013. 163(6):1592-1595. doi: 10.1016/j.jpeds.2013.07.011
7. 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
8. 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
9. Philip RK, Romeih E, Bailie E, et al. Exclusive human milk diet for extremely premature infants: a novel fortification strategy that enhances the bioactive properties of fresh, frozen, and pasteurized milk specimens. Breastfeed Med. April 2023;18(4):279-290. http://doi.org/10.1089/bfm.2022.0254
10. 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
11. 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
12. Data on file; estimated number of premature infants fed Prolacta's products from January 2007 to August 2023.
13. 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