Preliminary Data From Observational Study Presented at Australian and New Zealand Neonatal Network Clinical Practice Improvement Conference

ADELAIDE,Australia,Dec. 10,2024 -- Prolacta Bioscience®,the world's leading hospital provider of 100% human milk-based nutritional products,today announced results of an interim subgroup analysis of a prospective observational study.The study found an Exclusive Human Milk Diet (EHMD) was associated with a decreased rate of malnutrition in extremely low birth weight (ELBW) infants cared for at Royal Hospital for Women in Sydney,Australia. These preliminary findings come on the heels of Prolacta announcing availability of its Humavant® nutritional productsfor premature babies across New South Wales,Queensland,and South Australia.

The hospital compared malnutrition rates among ELBW infants (<1000 g) who received either an EHMD (n = 18) or a standard feeding protocol with cow milk-based fortifiers (n = 17) until they reached 34 weeks corrected gestational age (CGA). Using established weight-for-age z-scores,researchers defined mild malnutrition as 0.8-1.2 below the standard deviation (SD),moderate as >1.2-2.0 SD,and severe as >2.0 SD.1

Interim findings show:

Mild malnutrition incidence decreased from 35% in the control group to 28% in the EHMD group (p = 0.90).2

Moderate-to-severe malnutrition rates dropped from 53% to 11% in the EHMD group (p = 0.02).2

No cases of necrotizing enterocolitis (NEC),a serious intestinal disease,occurred in the EHMD group compared to 11% in the control group.2

Dr. Trish Parmar from the Royal Hospital for Women presented the data at the Australian and New Zealand Neonatal Network Clinical Practice Improvement Conference (ANZNN). The hospital continues to gather and analyze data,with additional results forthcoming.

About an Exclusive Human Milk Diet

An EHMD is achieved when 100% of the protein,fat,and carbohydrate in an infant's diet are derived from human milk,including Prolacta's Humavant® — the first and only human milk-based fortifier available to hospitals in certain regions of Australia.

Human milk nutrition is vital for the health and development of babies born prematurely. Given the estimated 20%–40% increase in caloric needs compared to full-term infants,3 a nutritional fortifier is often added to mum's own milk or donor breast milk to provide the nutritional support that is essential to premature infants' survival,growth,and development. Additionally,a recent studyfound that the use of a human milk diet with human milk-based fortifiers reduced mortality by 50% compared to a diet with cow milk-based fortifiers.4

Additional information can be found at prolacta.com/apac/en.

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 infants5 worldwide 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. Learn more at www.prolacta.com,onX,Instagram,Facebook,and LinkedIn.

Media Contact:

Loren Kosmont

Lkosmont@prolacta.com

310-721-9444

References

Goldberg DL,et al. Identifying malnutrition in preterm and neonatal populations: recommended indicators. J Academy Nutr Diet. 2018;118:1571-1582.

Parmar T,et al. Weight z-score changes with exclusive human milk diet in the extremely low birth weight infants – an interim subgroup analysis of prospective observational study. Poster presented at: Australian and New Zealand Neonatal Network Clinical Practice Improvement Conference (ANZNN); Oct. 21,2024; Sydney,Australia.

Hair AB,Bergner EM,Lee ML,et al. Premature infants 750-1,250 g birth weight supplemented with a novel human milk-derived cream are discharged sooner. Breastfeed Med. 2016;11(3):133-137. doi:10.1089/bfm.2015.0166

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

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