Neonatal Intensive Care

December 9, 2021

Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for premature and critically ill infants, announced the enrollment of the first baby into a Japan-based clinical trial evaluating growth and safety associated with an Exclusive Human Milk Diet including Prolacta's 100% human milk-based fortifiers (Prolacta's EHMD).

The Japan-based study — "JASMINE: A Randomized, Controlled Study to Assess Growth and Safety of the Exclusive Human Milk Diet (EHMD) in Very Low Birth Weight (VLBW) Infants" — began in October 2021. In Japan, Prolacta's human milk-based products will be registered as a drug.

"Initiation of this study in Japan is another industry first, being led by Prolacta," said Scott Elster, CEO of Prolacta. "Japan's regulatory authorities have very strict requirements for conducting drug trials. Our industry-leading quality and safety standards meet Pharmaceuticals and Medical Devices Agency. (PMDA) regulations, allowing us the opportunity to conduct this study and introduce an exceptional level of nutritional care for preterm babies in Japan."

"We know that Prolacta's EHMD is the gold standard diet for premature infants," said principal investigator, senior professor of pediatrics Dr Katsumi Mizuno, MD, PhD, of the Showa University School of Medicine in Tokyo. "This study is necessary to bring a higher level of nutritional care to our very low birth weight babies in Japan."

Mizuno-sensei, in association with a clinical research organization, will oversee the 10-site study taking place at Showa University Hospital, Showa University Koto Toyosu Hospital, Showa University Northern Yokohama Hospital, Nara Medical University Hospital, Saitama City Hospital, Fujita Health University, Tokyo Metropolitan Bokutoh Hospital, Nagano Children's Hospital, Takatsuki General Hospital, and Gifu Prefectural General Medical Center. The study will evaluate three of Prolacta's 100% human milk-based products.