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)

Youquan Wang¹Yanhua Li¹Ying Chen¹Yuhan Zhang¹Xuewen Feng¹Dongfang Lv¹Yumeng Chen¹Xu Bi¹Yongfu Yu²Yuwei Peng²Hongxiang Li¹Dong Zhang^1*

• ¹Bethune First Hospital of Jilin University, Changchun, China
• ²Fudan University School of Public Health, Shanghai, China

Objective: It 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. Design: This is a multicenter, cluster-randomized controlled trial. Setting: Ninety intensive care units (ICUs) across China. Participants: A total of 2,250 critically ill patients initiating early enteral nutrition who meet the inclusion criteria. Intervention: In addition to standard care, centers randomized to the intervention arm will implement nutritional therapy strictly according to the mNEED protocol. Primary Outcome Measure: The 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 Dissemination: This 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 Registration: This 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.