New Japanese RCT Landmark Results: Exclusive Human Milk Diet Drives Superior Growth in Premature Infants Without Increased Safety Risks
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20 Years Advancing NICU Nutrition and Improving Outcomes for Babies Under 3 Pounds

Prolacta Marks NICU Awareness Month Celebrating Two Decades Bringing 100% Breastmilk-Based Fortifiers & Formulas to NICUs Nationwide

DUARTE, Calif. (Sept. 2, 2026) – Prolacta Bioscience® is marking NICU Awareness Month and 20 years of providing 100% human breastmilk-based fortifiers and formulas, free from cow milk, for babies born under 3 pounds. Since introducing Prolact+ H2MF® in 2006, Prolacta has helped improve outcomes by changing how neonatal intensive care units (NICUs) feed the smallest premature infants, those weighing 2.75 pounds or less (<1250 g).

Supporting Growth in the Smallest Premature Infants

Extremely premature babies need significantly more calories, protein, and nutrients than full-term babies to catch up on the growth they didn’t receive in the womb. This is why doctors often add a nutritional "fortifier" to mom's breastmilk or donor milk for the smallest preemies. These fortifiers provide the extra nutrition necessary for healthy growth and development.

There are two types of fortifiers available in the NICU: one made from cow milk, and one made from donor breastmilk. In the U.S., both are labeled "human milk fortifiers," which can be confusing for parents and clinicians alike. However, only those from Prolacta are 100% donor breastmilk-based, free from cow milk and corn syrup ingredients.

How Early NICU Nutrition Can Shape Long-Term Development

What preemies are fed in the NICU doesn't just matter today; it impacts tomorrow’s developmental milestones. A recent study followed more than 1,000 premature babies from birth through age 3 to examine how their early nutrition affected their development.1 Babies fed an Exclusive Human Milk Diet (EHMD) including breastmilk and Prolacta’s human milk-based fortifiers were significantly less likely to have motor skill delays at age 3 compared to those fed a non-EHMD. These motor skills help toddlers walk, run, climb, and explore their world, along with other children their same age.

The positive health outcomes go beyond motor skills. Earlier research showed that an exclusive human milk diet also leads to significantly higher cognitive scores (thinking, learning, attention) at 18-22 months.2 Together, these studies reveal that the feeding choices parents and care teams make in the NICU can shape a child's development for years to come.

“For 20 years, Prolacta has provided a clinically proven alternative to cow milk-based fortifiers, supporting improved outcomes for the smallest, most vulnerable premature infants,” said Scott Elster, CEO of Prolacta. “With quality and safety at the center of everything we do, we’re gratified to help these babies go home sooner and continue to thrive as they grow and develop.”

About Prolacta Bioscience

Prolacta Bioscience® is the global leader in human milk-based nutrition, dedicated to improving health outcomes for critically ill and premature infants. More than 125,000 vulnerable infants worldwide have benefited from Prolacta’s human milk-based fortifiers and formulas since 2006.3 In a global first, Japan granted prescription drug status to Prolacta's PreemieFort® fortifiers in late 2025 for very low birth weight infants, infants with congenital gastrointestinal disorders or congenital heart disease, and those recovering from gastrointestinal surgery at risk for poor growth. Prolacta adheres to the industry’s strictest quality and safety standards, operating pharmaceutical processing facilities and applying more than 20 donor milk screening tests. Its use of vat pasteurization inactivates pathogens while keeping human milk closer to its natural state than other human milk processing methods, preserving the bioactive components of human milk that support immune protection, brain development, and growth in premature and medically fragile infants.4,5,6 Prolacta’s products have been evaluated in over 30 peer-reviewed clinical studies, demonstrating the short- and long-term health benefits of its patented human milk-based fortifiers and formulas. Learn more online or at X, Instagram, Facebook, TikTok, and LinkedIn.

Media Contact:

Loren Kosmont
Lkosmont@prolacta.com
310-721-9444

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References

  1. Chou FS, Zhang J, Villosis MFB, et al. Exclusive human milk diet is associated with lower risk of motor function impairment at three years of corrected age. J Perinatol. 2025. doi:10.1038/s41372-025-02296-z
  2. Data on file; estimated number of premature infants fed Prolacta's products from January 2007 to May 2025.
  3. 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:10.1038/s41372-022-01513-3
  4. Ozturk G, Paviani B, Rai R, et al. Investigating milk fat globule structure, size, and functionality after thermal processing and homogenization of human milk. Foods. 2024;13(8):1242. doi:10.3390/foods13081242
  5. Liang N, Koh J, Kim BJ, et al. 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. Published online September 15, 2022. doi:10.3389/fnut.2022.926814
  6. 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