AUTHOR=Wang Youquan , Li Yanhua , Chen Ying , Zhang Yuhan , Feng Xuewen , Lv Dongfang , Chen Yumeng , Bi Xu , Yu Yongfu , Peng Yuwei , Li Hongxiang , Zhang Dong 

TITLE=Modifying feeding protocols in critically ill patients based on a predictive model of feeding intolerance: protocol for a multicenter cluster randomized controlled trial (the mNEED study)

JOURNAL=Frontiers in Medicine

VOLUME=Volume 12 - 2025

YEAR=2025

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1649983

DOI=10.3389/fmed.2025.1649983

ISSN=2296-858X

ABSTRACT=ObjectivesIt remains unclear whether the modified nutrition protocol for critically ill patients (mNEED), based on the NOFI predictive model for feeding intolerance (FI), can reduce the incidence of FI and subsequently improve clinical outcomes.DesignThis is a multicenter, cluster-randomized controlled trial.SettingNinety intensive care units (ICUs) across China.ParticipantsA total of 2,250 critically ill patients initiating early enteral nutrition who meet the inclusion criteria.InterventionIn addition to standard care, centers randomized to the intervention arm will implement nutritional therapy strictly according to the mNEED protocol.Primary outcome measureThe primary outcome is the incidence of FI within the first 7 days of ICU admission. Secondary outcomes and process measures will also be reported. An intention-to-treat analysis will be conducted for the primary outcome to ensure the robustness of the findings.Ethics and disseminationThis study has been approved by the Ethics Committee of the First Hospital of Jilin University (original version: 24k004-001; revised version: 24k004-002) and by the ethics committees of all participating sites. Results will be disseminated through peer-reviewed publications and conference presentations.Trial registrationThis trial has been registered at the Chinese Clinical Trial Registry (ChiCTR2400081581): https://www.chictr.org.cn/showproj.html?proj=219477 and at ClinicalTrials.gov (NCT06827275): https://clinicaltrials.gov/study/NCT06827275.