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Objective <p>To determine safety and efficacy of exclusive human milk diet (EHMD) for very low birth weight (VLBW, &lt;1500 g) infants.</p> Design <p>Prospective, controlled, open trial of VLBW infants randomized to EHMD (mother’s own milk [MOM]/donor milk [DM] with human milk-based fortifiers) or Standard Diet (MOM/DM with cow milk-based fortifier/formula). Outcomes included superiority of weight gain velocity from birth to 34 weeks gestational age, time to full feeds, and safety.</p> Result <p>In total, 147 infants received EHMD (<i>n</i> = 77) or Standard Diet (<i>n</i> = 70). The EHMD group had superior mean weight gain velocity versus the Standard Diet (13.44 vs 11.96 g/kg/day, <i>p</i> = 0.006) and earlier mean time to full feeds (20.0 vs 25.9 days, <i>p</i> = 0.03); adverse events were not significantly different (32.5% vs 21.4%, <i>p</i> = 0.13).</p> Conclusion <p>EHMD is viable for management of VLBW infants, providing improved growth without reduced safety.</p> Trial Registration and ID <p>Japan Registry of Clinical Trials: jRCT2031210384</p>

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Growth and safety evaluation in very low birth weight infants receiving an exclusive human milk diet: a phase III randomized control trial in Japan

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月27日

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  • Katsumi Mizuno,
  • Tokuo Miyazawa,
  • Utako Kondo,
  • Toshiya Nishikubo,
  • Yutaka Yamamoto,
  • Yuya Nakano,
  • Takehiko Hiroma,
  • Kazushige Ikeda,
  • Masahiko Murase,
  • Hitomi Jimi,
  • Isamu Hokuto,
  • Masafumi Miyata

摘要

Objective

To determine safety and efficacy of exclusive human milk diet (EHMD) for very low birth weight (VLBW, <1500 g) infants.

Design

Prospective, controlled, open trial of VLBW infants randomized to EHMD (mother’s own milk [MOM]/donor milk [DM] with human milk-based fortifiers) or Standard Diet (MOM/DM with cow milk-based fortifier/formula). Outcomes included superiority of weight gain velocity from birth to 34 weeks gestational age, time to full feeds, and safety.

Result

In total, 147 infants received EHMD (n = 77) or Standard Diet (n = 70). The EHMD group had superior mean weight gain velocity versus the Standard Diet (13.44 vs 11.96 g/kg/day, p = 0.006) and earlier mean time to full feeds (20.0 vs 25.9 days, p = 0.03); adverse events were not significantly different (32.5% vs 21.4%, p = 0.13).

Conclusion

EHMD is viable for management of VLBW infants, providing improved growth without reduced safety.

Trial Registration and ID

Japan Registry of Clinical Trials: jRCT2031210384