Modified feeding regimen for critically ill adults guided by a feeding-intolerance prediction model

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

mNEED is a multicenter, cluster-randomized, controlled trial comparing a modified enteral feeding regimen guided by a feeding-intolerance prediction model to usual feeding practice in adult ICUs. ICUs (clusters) in Grade 2+ hospitals are randomized to apply the model-based feeding protocol or continue standard care, and eligible patients are adults with recent organ failure (SOFA ≥2), expected ICU stay >48 hours, unable to eat orally and without enteral nutrition contraindications. The intervention adjusts the enteral feeding process based on predicted risk of feeding intolerance, with outcomes focused on feeding tolerance, nutrition delivery, and clinical course during the ICU stay. Key exclusions include recent enteral nutrition within three days, AGI level IV, expected imminent death, pregnancy, long-term immunosuppression, active chemo/radiotherapy, or concurrent trial participation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Age 18 or older Failure of one or more organ systems within 24 hours of admission to the ICU (SOFA score ≥2) Expected to stay in ICU for more than 48 hours Inability to eat orally No EN taboo

ICU Selection Criteria:

ICU in Grade 2 or above hospitals ICU with the ability to carry out intensive care and monitor patient FI ICU type: emergency, medical, surgical, neurosurgical, or comprehensive ICU

Exclusion Criteria:

Patients who have received EN treatment in the past three days AGI Level IV patients Receiving palliative care and expected to die within 48 hours Pregnancy Long-term use of steroids or other immunosuppressants Patients undergoing radiotherapy or chemotherapy for malignant diseases Participation in other clinical studies

ICU Exclusion Criteria:

ICU that refuses to participate in the study ICU that has not passed the ethical review Pediatric ICU

Where it's running

• The First Hospital of Jilin University
  Changchun, Jilin, China Recruiting
• Jilin University, Chaoyang District, Changchun City, Jilin Province
  Changchun, Jilin, China Not yet recruiting

Study contacts

• Study coordinator: Dong Zhang
• Email: zhangdong@jlu.edu.cn
• Phone: +86 155 8429 9391

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.