• Better Growth Has Been Associated with Improved Long-Term Neurodevelopment
• Prolacta's Human Milk-Based Fortifiers Proved Safe and Effective Alternative to Japan's Practice of Delaying Cow Milk-Based Fortifiers to Avoid Complications
• JASMINE Data Used by Japan's Ministry of Health, Labour, and Welfare to Grant Prolacta's Fortifiers Prescription Drug Status, a Global First in Neonatal Care

DUARTE, Calif., April 30, 2026 /PRNewswire/ -- A landmark clinical trial published in the Journal of Perinatology has resolved a long-standing dilemma facing Japan's neonatal clinicians: how to provide the critical early nutrition that extremely premature infants need for growth and neurodevelopment while maintaining the country's exceptionally low rate (<2%) of necrotizing enterocolitis (NEC), an often fatal intestinal disease.

The answer, the study found, lies in feeding these fragile infants Prolacta Bioscience's 100% human milk-based fortifiers, versus Japan's standard practice of avoiding or markedly delaying cow milk-based fortifiers (CMBF) due to the known risk of NEC and other complications. Across 11 Japanese neonatal intensive care units (NICUs), the JASMINE randomized trial found that early fortification with Prolacta's fortifiers delivered significantly faster growth (weight gain 14.30 ± 2.86 vs. 11.96 ± 3.08 g/kg/day, p < 0.0001, PPS) and earlier achievement of full feeds (20.0 vs. 25.9 days; p = 0.03), with fewer days on antibiotics (adjusted p = 0.002), while demonstrating a safety profile consistent with Japan's standard of care.¹

A Clinical Trade-off and Dilemma: World-Class Survival, Sometimes at the Cost of Growth and Neurodevelopment

Japan is a world leader in preterm infant survival, with 80–90% of infants born at 22–24 weeks' gestation surviving to discharge.^2,3 But those outcomes came with an unintended cost. Inadequate nutritional intake potentially left vulnerable infants without the nutritional support essential for growth and brain development.

"There is great hesitancy to feed and fortify infants with cow milk-based products early. In Japan, a practice has become widespread of not feeding infants until the mother's own milk becomes available, and this delay can subsequently impair infant growth and neurodevelopment," said lead author Katsumi Mizuno, MD, PhD, Department of Pediatrics, Showa University School of Medicine, Tokyo, Japan. "In addition, there is a tendency to avoid the use of cow milk-derived human milk fortifiers in very low birth weight infants with a history of gastrointestinal surgery, which may likewise compromise growth and development. With the results of this trial and the release of the human milk-based fortifier drugs in Japan, Japanese doctors will no longer have to compromise nutrition for safety."

"Japan's clinicians recognized that better growth today has direct implications for neurodevelopment, cognitive outcomes, and quality of life for their most fragile infants," said Melinda Elliott, MD, FAAP, neonatologist and chief medical officer at Prolacta. "Dr. Mizuno began by requesting Prolacta's products for compassionate use and has created a pathway that ensures Japanese infants don't just survive but thrive."

The Role of Human Milk Fat in Early Brain Development

Human milk contains intact milk fat globules (MFGs) that are essential for delivering brain-critical fats and nutrients that support neurodevelopment in premature infants.⁴ Prolacta's human milk-derived fat modular, Prolact CR®, played a central role in the JASMINE protocol.

More than 95% of the infants in the human milk arm of the JASMINE study received Prolact CR, which is composed of 25% human milk fat and maintains the intact human MFG. Prolact CR was shown in a separate study to significantly increase weight and length velocity in very low birth weight infants.⁵

In addition to intact MFGs, all of Prolacta's nutritional products contain a wide spectrum of human milk oligosaccharides (HMOs), the third-most-abundant component in human milk after lactose and lipids.⁶ Compared to cow milk-based products, Prolacta's fortifiers contain significantly higher concentrations of beneficial bioactive components like immunoglobulin A and epidermal growth factor.⁷

Better Growth for Neurodevelopmental Support, Without Compromising Safety

The Japanese-led JASMINE trial was a randomized, controlled, open-label, multicenter study that evaluated the use of Prolacta's human milk-based feeding protocol in comparison to the Japanese Standard Diet, with a common practice to withhold or delay CMBF to avoid complications.

Key findings: 

• Infants fed an Exclusive Human Milk Diet (EHMD) demonstrated significantly better weight gain velocity (13.44 vs. 11.96 g/kg/day, p = 0.006), compared to infants fed the Standard Diet (in the ITT set).¹   
• In the per protocol set (PPS), the EHMD group demonstrated an even greater difference in weight gain compared to the Standard Diet group (14.30 vs. 11.96 g/kg/day, p < 0.0001).¹       
• Infants fed an EHMD also demonstrated significantly better length gain velocity compared to infants fed the Standard Diet (0.85 vs. 0.66 cm/week, p ≤ 0.0016, PPS).¹ 
• Infants in the EHMD group experienced a significantly lower number of days on antibiotics (adjusted p = 0.002) compared to the Standard Diet group.¹  
• Infants in the EHMD group achieved clinically appropriate feeding volumes faster (20.0 vs. 25.9 days, p = 0.03).¹     
• The EHMD demonstrated a safety profile consistent with neonatal expectations in Japan.¹  
• Though randomized, the EHMD group included twice as many infants born at 22–23 weeks' gestation, 10 infants vs. five, compared to the Standard Diet group,¹ making the findings even more meaningful.

The JASMINE protocol included Prolact CR fat modular, Prolact+6® and Prolact+8® human milk-based fortifiers. All three products are marketed under the prescription drug name PreemieFort® Enteral Solution in Japan.

A Growing Body of Evidence Links Early Human Milk-Based Fortification to Improved Neurodevelopment

Because the brain is growing at its most rapid pace, the nutrition premature infants receive in the first days and weeks of life can shape their long-term neurodevelopment.^8-10 A growing body of evidence links Prolacta fortifiers with improved neurodevelopment and better long-term outcomes for premature infants:

• A 2025 multicenter study across 13 Southern California NICUs (1,000+ infants) found premature infants who received Prolacta's Exclusive Human Milk Diet were significantly less likely to have motor skill delays by age 3, compared with infants fed a non-EHMD, despite the infants in the EHMD arm being born three weeks earlier and weighing more than 300 grams less at birth.¹¹
• A 2022 study found that infants fed Prolacta's EHMD had significantly higher cognitive scores and a trend toward improved language scores at 18–22 months corrected age, compared to those fed cow milk-based products.¹² Clinical findings also show premature infants fed Prolacta's EHMD reached the same healthy growth and developmental milestones by age 2 seen in full-term infants.⁸  

JASMINE study data drove Japan's landmark decision to approve Prolacta's human milk-based fortifiers as prescription drugs for premature and post-surgical infants, making them the first human milk-based nutritional products to receive drug-level designation anywhere in the world.

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 2006.¹³ 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.^14-16 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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