Improved Survival and Growth While Cutting Malnutrition for Premature Infants Fed Human Milk-Based Fortifiers at Sydney Hospital

Study Demonstrates Multiple Benefits of Prolacta’s Exclusive Human Milk Diet Compared to Traditional Cow Milk-Based Feeding Protocol

ADELAIDE, Australia, May 13, 2025 /PRNewswire/ — Prolacta Bioscience^®, the world’s leading hospital provider of 100% human milk-based nutritional products, today announced results from an interim analysis of the Personalised Enteral Nutrition (PEN) Study demonstrating the benefits of an Exclusive Human Milk Diet (EHMD) for extremely low birth weight (ELBW) infants.

Reduced rates of mortality, improved growth across multiple measurement methods, and reduced malnutrition were some of the findings of using human milk-based products when compared to cow milk-based products.

The findings, presented as three posters at the Australian and New Zealand Neonatal Network (ANZNN) Clinical Practice Improvement Conference and the Perinatal Society of Australia and New Zealand (PSANZ) Conference, add to a growing body of research showing the lifesaving potential of Prolacta’s Humavant^® 100% human milk-based fortifiers and follow the recent introduction of the products across New South Wales, Queensland, and South Australia.^1,2,3 

Conducted at the Royal Hospital for Women in Sydney, the study evaluated outcomes among ELBW infants (<1000 g) who received either Prolacta’s human milk-based fortifiers or a standard feeding protocol with cow milk-based fortifiers until they reached 34 weeks corrected gestational age (CGA).

Key findings from the three PEN Study analysis posters:

Poster 1

• Decreased incidence of malnutrition at 34 weeks CGA from 88% in the control group (n = 17) to 39% in the EHMD group (n = 18)¹
    
• Decreased mild malnutrition incidence from 35% in the control group to 28% in the EHMD group (p = 0.90)
    
• Reduced rate of moderate-to-severe malnutrition from 53% in the control group to 11% in the EHMD group (p<0.05)¹
    
• No cases of necrotizing enterocolitis (NEC), a serious intestinal disease, in the EHMD group compared to 11% in the control group¹

Poster 2

• Better weight gain in the EHMD group (n = 21), with mean weight increasing by 620 g (±222 g) by day 42 compared to 469 g (±154 g) in the control group (n = 18) (p = 0.017)²
   
• Higher mean head circumference in the EHMD group, increasing by 3.54 cm (±2.57 cm) by day 42 compared to 2.46 cm (±1.26 cm) in infants in the control group (p = 0.11)²
   
• 100% survival rate and no occurrence of NEC in the EHMD group²
   
• No deaths due to late-onset sepsis in the EHMD group compared to 11% mortality in infants receiving cow milk-based fortifiers²

Poster 3

• Earlier commencement of fortification in the EHMD group: 10.4 days vs. 20.8 days in the control group (p < 0.01)³ 
   
• Earlier attainment of full enteral feeds of 150 mL/kg/day in the EHMD group: 12.7 days vs. 20.2 days in the control group (p < 0.01)³ 
   
• Reduced duration of parenteral nutrition in the EHMD group: 12.8 days vs. 20.3 days (p < 0.05)³ 
   
• Smaller decline in weight z-scores (-0.9 vs -1.6, p < 0.05) and head circumference z-scores (-0.9 vs -1.6) from birth to 36 weeks CGA in the EHMD group³

About an Exclusive Human Milk Diet

Humavant fortifiers are the first and only human milk-based products available to hospitals in various regions of Australia as an alternative to cow milk-based nutritional fortifiers for babies born prematurely. Royal Hospital for Women is the first to publish data on its clinical experience using Humavant fortifiers as a part of an EHMD protocol. 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 fortifiers. 

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,⁴ 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 study found 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.⁵ 

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 infants⁶ 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 prolacta.com/apac/en, on X, Instagram, Facebook, TikTok, and LinkedIn.  

Media Contact:
Loren Kosmont
Lkosmont@prolacta.com
310-721-9444

References

1. Parmar T, Allworth S, Tapawan S, Lui K, Schindler T, Bolisetty S. 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.
    
2. Parmar T, Tapawan SJ, Allworth S, et al. Growth trajectory of preterm infants ≤1000g on an exclusive human milk diet – first Australian experience: an interim subgroup analysis of the personalised enteral nutrition (PEN) study. Poster presented at: Australian and New Zealand Neonatal Network Clinical Practice Improvement Conference (ANZNN); Oct. 21, 2024; Sydney, Australia.
    
3. Parmar T, Tapawan SJ, Allworth S, et al. Impact of standardised nutrition bundle with exclusive human milk diet on anthropometric z-score trends in preterm neonates <1000g: interim analysis of personalised enteral nutrition (PEN) study. Poster presented at: Australian and New Zealand Neonatal Network Clinical Practice Improvement Conference (ANZNN); Oct. 21, 2024; Sydney, Australia.
    
4. 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
    
5. 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
    
6. Data on file; estimated number of premature infants fed Prolacta’s products from January 2007 to August 2023.

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