Modified feeding regimen for critically ill adults guided by a feeding-intolerance prediction model
Modifying Feeding Protocols for Critically Ill Patients (mNEED) Based on a Predictive Model of Feeding Intolerance in Critically Ill Patients: a Multicentre, Cohorts Randomized, Controlled Trial
This trial tests whether using a prediction model to guide enteral feeding schedules helps critically ill adult ICU patients tolerate and receive nutrition better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Changchun, Jilin and 1 other locations) |
| Trial ID | NCT06827275 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) admitted to a participating ICU with organ dysfunction within 24 hours (SOFA ≥2), expected to stay >48 hours, unable to eat orally, and with no contraindication to enteral nutrition are ideal candidates.
Not a fit: Patients with severe gastrointestinal failure (AGI level IV), those who recently received enteral nutrition, those receiving palliative care with expected survival <48 hours, pregnant patients, or those on long-term immunosuppression or active chemo/radiotherapy are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, the approach could reduce feeding intolerance and improve the amount of nutrition delivered to critically ill patients, which may lower complications and support recovery.
How similar studies have performed: Protocolized enteral feeding and some predictive tools have shown modest improvements in nutrition delivery and reduced intolerance in prior studies, but cluster-randomized trials using model-guided regimens are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Changchun, Jilin and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.