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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 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.
Japan is a world leader in preterm infant survival, with 80–90% of infants born at 22–24 weeks' gestation surviving to discharge. 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, Department of Paediatrics, 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, 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.”
Human milk contains intact milk fat globules that are essential for delivering brain-critical fats and nutrients that support neurodevelopment in premature infants. 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.
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.
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).
- 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).
- 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).
- Infants in the EHMD group experienced a significantly lower number of days on antibiotics (adjusted p = 0.002) compared to the Standard Diet group.
- Infants in the EHMD group achieved clinically appropriate feeding volumes faster (20.0 vs. 25.9 days, p = 0.03).
- The EHMD demonstrated a safety profile consistent with neonatal expectations in Japan.
- 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, making the findings even more meaningful.
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. A growing body of evidence links Prolacta fortifiers with improved neurodevelopment and better long-term outcomes for premature infants.
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