Improving Feeding Protocols for Critically Ill Adult Patients Using a Model to Predict Feeding Intolerance A Multicenter Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating a modified feeding regimen mNEED designed to reduce feeding intolerance in critically ill patients admitted to intensive care units ICUs. This multicenter, cluster-randomized controlled trial builds upon previous nutrition guidelines and a predictive model of feeding intolerance NOFI to improve nutritional therapy while addressing common feeding complications. The study is sponsored by the First Hospital of Jilin University and aims to enroll 2,250 patients from 90 ICUs nationwide. Participants will be randomly assigned by ICU to either the experimental group receiving the mNEED feeding procedures or a control group following the current 2023 ESPEN guidelines for feeding. Nutritional therapy is administered according to the assigned feeding procedures, with no additional interventions or charges. The study involves standard care practices with close monitoring to promptly manage any serious gastrointestinal adverse events. During the study, researchers will assess participants for feeding intolerance within 7 days of ICU admission as the primary outcome. Secondary outcomes include nutrition goal achievement, mortality rates at 28 and 90 days, quality of life surveys SF-36 and EQ-5D-5L, muscle thickness measurements, new infections, ICU length of stay, and ventilator-free days. Medical records and clinical data will be securely collected and analyzed while maintaining patient confidentiality. Participation is voluntary, with no additional risk beyond standard care.

mNEED: a Multicentre, Cluster-randomized, Controlled Trial