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)

TL;DR

This study tests a new feeding protocol for critically ill patients to reduce feeding intolerance and improve outcomes.

Contribution

The mNEED study introduces a predictive model-based protocol to reduce feeding intolerance in ICU patients.

Findings

The mNEED protocol will be tested across 90 ICUs in China.

The primary outcome is the incidence of feeding intolerance within the first 7 days of ICU admission.

Abstract

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.

This is a multicenter, cluster-randomized controlled trial.

Ninety intensive care units (ICUs) across China.

A total of 2,250 critically ill patients initiating early enteral nutrition who meet the inclusion criteria.

In addition to standard care, centers randomized to the intervention arm will implement nutritional therapy strictly according to the mNEED protocol.

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.

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.

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.

Figures