Your new experience awaits. Try the new design now and help us make it even better

ORIGINAL RESEARCH article

Front. Pediatr.

Sec. Neonatology

Volume 13 - 2025 | doi: 10.3389/fped.2025.1679676

This article is part of the Research TopicWorld Food Safety Day: Innovations in Neonatal Food SafetyView all articles

Analysis of NEC Cases Registered in the Human Milk Bank Database

Provisionally accepted
Katsumi  MizunoKatsumi Mizuno1*Yuka  Sano WadaYuka Sano Wada2Motoichirou  SakuraiMotoichirou Sakurai3Yuki  TaniYuki Tani4Masafumi  MiyataMasafumi Miyata5Jun  ShindoJun Shindo6Hiroki  DenHiroki Den7Shigeru  NichimakiShigeru Nichimaki8
  • 1Showa Daigaku Daigakuin Igaku Kenkyuka Igakubu Shonikagaku, Shinagawa, Japan
  • 2Kokuritsu Kenkyu Kaihatsu Hojin Kokuritsu Seiiku Iryo Kenkyu Center, Setagaya, Japan
  • 3Kameda Sogo Byoin, Kamogawa, Japan
  • 4Nara Kenritsu Ika Daigaku, Kashihara, Japan
  • 5Fujita Ika Daigaku, Toyoake, Japan
  • 6Tokyo Toritsu Shoni Sogo Iryo Center, Fuchu, Japan
  • 7Showa Daigaku, Shinagawa, Japan
  • 8Yokohama Shiritsu Daigaku, Yokohama, Japan

The final, formatted version of the article will be published soon.

Background: Necrotizing enterocolitis (NEC) remains a major cause of morbidity and mortality in extremely low birth weight infants (ELBWIs), despite widespread donor human milk (DHM) use. This study examined NEC cases among DHM recipients to explore potential contributing factors. Methods: We retrospectively analyzed 1,425 infants registered in Japan’s human milk bank database (2018–2023). NEC cases at Bell stage ≥II were confirmed by attending physicians. Infants who received DHM only after NEC onset were excluded. Cases were categorized by onset timing and associated clinical factors. Results: Among 1,324 very low birth weight infants, 21 (1.58%) developed NEC, with 20 requiring surgical intervention. Median gestational age and birth weight were 25.1 weeks and 637 g, respectively. NEC onset was classified as follows: within 7 days of birth (n=5), after 2 months (n=5), after formula or fortifier use (n=6), associated with hemodynamic changes (n=7), or of unknown etiology (n=4). Common factors included symptomatic PDA, congenital heart disease, infection, formula exposure, and ophthalmologic procedures. Conclusion: NEC can develop despite DHM use, often in association with early infections, PDA, or fortification. Strategies to further reduce NEC incidence should include management of hemodynamic instability, delayed formula introduction, and use of exclusive human milk-based diets. Further research should explore potential roles of ophthalmologic interventions and human milk fortifiers in NEC development.

Keywords: Donor human milk, necrotizing enterocolitis, Human milk bank, Preterminfants, Fortifier, ELBWI, Hemodynamic instability, PDA

Received: 05 Aug 2025; Accepted: 28 Aug 2025.

Copyright: © 2025 Mizuno, Wada, Sakurai, Tani, Miyata, Shindo, Den and Nichimaki. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Katsumi Mizuno, Showa Daigaku Daigakuin Igaku Kenkyuka Igakubu Shonikagaku, Shinagawa, Japan

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.