mNEED: a Multicentre, Cluster-randomized, Controlled Trial

NCT06827275 | Recruiting

• 2 other identifiers: mNEEDstudy2025320.6750.2024-25-6
• Study Type: interventional
• Target: 2,250
• Locations: 1 country
• Sites: 2

Brief Summary

Project Name: Improved Feeding Regimen for Critically Ill Patients (mNEED) Based on Feeding Intolerance Prediction Model Solution version number and version date: Version 5.0; 2024.12.16 Informed consent version number and version date: Version 1.0; 2023.10.19 Dear Patient, Recently, the department participated in a nationwide study to develop nutrition protocols for critically ill patients. Participation in a "Modified Feeding Regimen for Critically Ill Patients Based on a Predictive Model of Feeding Intolerance in Critically Ill Patients (mNEED): a multicenter, cohort randomized, controlled trial" is being invited. Before deciding whether to participate in the study, it is important to read the following information carefully to understand the clinical treatment study, its purpose, procedures, duration, and potential benefits, discomforts, and risks. If desired, the information can be discussed with relatives, friends, or the attending physician to assist in making an informed decision. For any questions, please direct them to the physician in charge of the study. I. Introduction of Clinical Trials Research Background and Purpose Leading international evidence-based guidelines consistently recommend early targeted nutritional therapy for critically ill patients. However, multicenter cluster-randomized controlled trials (cRCTs) evaluating the impact of implementing these guidelines have not demonstrated patient benefit. In 2022, Ke et al. proposed evidence-based Feeding Guidelines for Critically Ill Patients (NEED), which provided a specific feeding regimen for nutritional therapy in critically ill patients. The results suggested that the NEED group initiated enteral nutrition (EN) earlier and reduced the use of overall parenteral nutrition (PN). However, the NEED feeding strategies did not reduce the incidence of feeding intolerance in critically ill patients. In previous studies, a predictive model of feeding intolerance (NOFI) in critically ill patients was constructed, demonstrating good predictive power. Therefore, the NEED feeding program will be improved (mNEED) based on NOFI to reduce the occurrence of feeding intolerance (FI) while ensuring the nutritional needs of critically ill patients are met. Research Process Research Funds: All treatment methods involved in this study follow conventional treatment procedures, without additional interventions or charges. Study Content: This study is conducted by the Department of Intensive Care Medicine of the First Hospital of Jilin University, with 2,250 patients expected to be enrolled from ICUs in 90 hospitals nationwide. This study is a multicenter cluster randomized controlled trial, where each center is randomly divided into an experimental group and a control group. Data will be summarized and analyzed statistically. Possible Risks This study involves an improvement in the feeding strategy for critically ill patients and will not cause additional risks. In the event of serious gastrointestinal adverse events, symptomatic management will be provided promptly. Subject Benefits All participants in the study will be examined and treated by clinically experienced physicians, who will address questions and provide timely and thoughtful medical services. Participation may lead to improved conditions, and the results of this study may benefit other patients with similar conditions. Voluntary Participation and Withdrawal Before the trial, a detailed understanding of the clinical trial is encouraged. The hospital and the attending physician are obligated to provide information related to the clinical trial and address any concerns. Participation in the clinical trial treatment is voluntary. Duty of Confidentiality Medical records (including medical history, physical examination reports, and laboratory results) will be securely stored in the hospital. Access to these records will be limited to physicians (researchers), professional academic committees, ethics committees, and health supervision and management departments. Any public reporting of the study results will not disclose personal identities. Every effort will be made to protect the privacy of personal medical information to the extent permitted by law.

Conditions

Feeding; ICU

Keywords

Nutritional support; prognosis; Feeding intolerance; Intensive care unit; Enteral nutrition

Outcome Measures

Primary Outcomes (1)

• Feeding intolerance

  Intolerance to enteral feeding for any clinical reason (vomiting, high gastric residue, diarrhea, gastrointestinal bleeding, etc.). FI should be considered present if at least 20 kcal/kg BW/day via enteral route cannot be reached within 72 h of feeding attempt or if enteral feeding has to be stopped for whatever clinical reason. Vomiting: Any visible regurgitation of gastric contents, regardless of volume. High Gastric Residual Volume (GRV): GRV \> 200 mL per single measurement, assessed every 4 hours via syringe aspiration from the gastric/jejunal tube. Diarrhea: Three or more loose or liquid stools per day, with a stool weight greater than 200-250 g/day (or greater than 250 mL/day). Gastrointestinal Bleeding: Any bleeding within the gastrointestinal lumen, confirmed by visible blood in vomitus, gastric aspirate, or stool.

  Within 7 days in the ICU

Secondary Outcomes (12)

• Nutrition goal achievement

  ICU day 7

• 28-day mortality rate

  Day 28 after ICU admission

• 90-day mortality

  Day 90 after ICU admission

• SF-36 (Short Form-36 Health Survey)

  Day 28 and 90 after ICU admission

• EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)

  Day 28 and 90 after ICU admission

Study Arms (2)

mNEED

EXPERIMENTAL

mNEED special feeding procedures set by the experimental group

Procedure: Feeding process

guideline

ACTIVE COMPARATOR

Feeding according to the current 2023 ESPEN guidelines

Procedure: Feeding process

Interventions

Feeding process PROCEDURE

Nutritional therapy is administered according to the feeding procedure

guideline; mNEED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (2)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

Jilin University, Chaoyang District, Changchun City, Jilin Province

Changchun, Jilin, 130021, China

NOT YET RECRUITING

Related Publications (1)

• Wang Y, Li Y, Chen Y, Zhang Y, Feng X, Lv D, Chen Y, Bi X, Yu Y, Peng Y, Li H, Zhang D. 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). Front Med (Lausanne). 2025 Nov 6;12:1649983. doi: 10.3389/fmed.2025.1649983. eCollection 2025.

  PMID: 41281994 DERIVED

Central Study Contacts

Dong Zhang

CONTACT

+86 155 8429 9391; zhangdong@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized controlled trial

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: February 14, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)