621 - Assessment of Growth and Safety in Infants with Very Low Birth Weight Receiving an Exclusive Human Milk Diet: A Phase III Randomized Control Trial in Japan

Publication Number: 621.3574

Katsumi Mizuno, Showa University School of Medicine, Department of Pediatrics, Tokyo, Tokyo, Japan; Tokuo Miyazawa, Showa University School of Medicine, Shinagawa-ku, Tokyo, Japan; Utako Kondo, metropolitan Bokutoh Hospital, Tokyo, Tokyo, Japan; Toshiya Nishikubo, Nara Medical University Hospital, Kashihara, Nara, Japan; Yutaka Yamamoto, Gifu Prefectural General Medical Center, Gifu, Gifu, Japan; Yuya Nakano, Showa University School of Medicine, Tokyo, Tokyo, Japan; Takehiko Hiroma, Nagano Children Hospital, Japan,, Azumino, Nagano, Japan; Kazushige Ikeda, Division of Neonatology, Department of Pediatrics, Saitama City Hospital, Saitama City, Saitama, Japan; Masahiko Murase, Showa University, Yokohama, Kanagawa, Japan; Hitomi Jimi, Takatsuki General Hospital, takatsuki city, Osaka, Japan; Isamu Hokuto, St. Marianna university, Kawasaki, Kagawa, Japan; Masafumi Miyata, Department of Pediatrics, Fujita Health University School of Medicine, Toyoake, Aichi, Japan

Background: Human milk is the best nutrition for very premature infants. They require a greater nutritional intake than full term infants, therefore human milk fortifier is necesassary to increase nutritional intake.

Objective: To determine the safety and efficacy of an exclusive human milk diet (EHMD) in promoting the growth of infants with very low birth weight (VLBW), compared with a cow milk-based (CMB) “Standard Diet.”

Design/Methods: Infants with VLBW ( < 1500 g) were randomized to receive either an EHMD, consisting of mother’s own milk (MOM) and/or donor milk (DM) with human milk-based fortifiers or a Standard Diet consisting of MOM/DM with CMB products. Outcomes included superiority of weight gain velocity, time to achieve full feed, and safety. Trial Registration and ID: Japan Registry of Clinical Trials: jRCT2031210384, Trial name JASMINE (JApanese Study of an Exclusive Human MIlk Diet in Premature Neonates)

Results: Of 147 enrolled infants (129 Japanese), 77 (44 males; mean gestational age ± SD, 27.05 ± 2.588 weeks) and 70 (33 males; mean gestational age ± SD, 27.63 ± 2.324 weeks) were assigned to the EHMD and Standard Diet groups, respectively. Infants in the EHMD group had superior growth compared with those in the Standard Diet group (mean weight gain velocity ± SD, 13.44 ± 3.914 vs 11.96 ± 3.061 g/kg/day, respectively, P = .0063) and also achieve full feed significantly ahead of the Standard Diet group (mean 20.0 days vs 25.9 days, P = .0300). Although there were twice as many infants born at 22/23 weeks of gestation in the EHMD group compared to the standard group, there were not any significant differences in adverse events between groups.

Conclusion(s): EHMD is a viable nutritional management strategy for Japanese infants with VLBW with enhancement of growth outcome without heightened safety risks.