FeedingmNEEDNCT06827275
mNEED: a Multicentre, Cluster-randomized, Controlled Trial
A study testing Feeding process in people with Feeding and ICU, run by The First Hospital of Jilin University at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Feeding process
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,250 participants
- Where
- 2 sitesChina
- Study dates
- 25 Feb 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130000
Youquan Wang, +86 139 4411 3202, wangyq20@mails.jlu.edu.cn
- Not yet recruiting
Jilin University, Chaoyang District, Changchun City, Jilin Province
Changchun, Jilin, 130021
Youquan Wang, +86 139 4411 3202, wangyq20@mails.jlu.edu.cn
About this study
Official title: 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
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.
Read more
- 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.
- Being tested
- Feeding process
- Keywords
- Nutritional support, prognosis, Feeding intolerance, Intensive care unit, Enteral nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding processProcedure or surgery
Nutritional therapy is administered according to the feeding procedure
| Study group | Role | What they receive |
|---|---|---|
| mNEED | Experimental | mNEED special feeding procedures set by the experimental group Receives: Procedure: Feeding process |
| guideline | Active comparator | Feeding according to the current 2023 ESPEN guidelines Receives: Procedure: Feeding process |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 7 days in the ICU
Secondary outcomes (12)
Nutrition goal achievement
Proportion of Participants Achieving Nutritional Goals (Caloric Intake: 25 kcal/kg/day; Protein Intake: 1.3 g/kg/day) at Day 7 in the ICU Definition: The proportion of critically ill patients achieving at least 80% of their nutritional goals (caloric intake: 25 kcal/kg/day; protein intake: 1.3 g/kg/day) by Day 7 in the ICU. Nutritional intake will be calculated based on daily enteral and parenteral nutrition records, including calorie and protein intake data extracted from electronic medical records or nutrition monitoring tools.
Measured: ICU day 7
28-day mortality rate
Death on the 28th day after ICU admission
Measured: Day 28 after ICU admission
90-day mortality
Death on the 90th day after ICU admission
Measured: Day 90 after ICU admission
SF-36 (Short Form-36 Health Survey)
SF-36 (Short Form-36 Health Survey) Score at Day 28 and Day 90 After ICU Admission Definition: The SF-36 is a widely used, patient-reported survey of health-related quality of life. It consists of 36 items covering eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored on a scale of 0 to 100, with higher scores indicating better health status. The SF-36 score will be assessed at Day 28 and Day 90 after ICU admission.
Measured: Day 28 and 90 after ICU admission
EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Day 28 and Day 90 After ICU Admission Definition: The EQ-5D-5L is a standardized instrument for measuring health-related quality of life. It consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity (no problems, slight problems, moderate problems, severe problems, and extreme problems).
Measured: Day 28 and 90 after ICU admission
diaphragm thickness
Measure the thickest part of the diaphragm during inspiration (when inhaling). Use a 5-15 MHz linear array probe positioned between the mid-axillary and anterior axillary lines at the 8th to 11th intercostal spaces, with the marker pointing cephalad. The diaphragm is typically located at a depth of 2 to 4 cm and appears as a three-layered structure between the pleural and peritoneal lines. It is recommended to measure the diaphragm thickness perpendicular to the fibrous direction between the pleural and peritoneal lines, excluding the membrane.
Measured: ICU day 7
quadriceps thickness
With the lower limb lying flat, the midpoint of the line connecting the upper edge of the patella and the anterior superior iliac spine is used as the measurement point. A 5-15 MHz linear array probe is placed perpendicular to the femur, applying minimal probe pressure to avoid deformation of subcutaneous fat and muscle.
Measured: ICU day 7
rectus femoris cross-sectional area
With the lower limb lying flat, the measurement point is located at the lower third of the line connecting the anterior superior iliac spine and the upper edge of the patella. A 5-15 MHz linear array probe is placed perpendicular to the femur, applying minimal probe pressure to avoid deformation of subcutaneous fat and muscle. For patients with a larger muscle cross-sectional area, if the width of the linear probe cannot provide a complete view of the muscle, a convex array probe may be used instead.
Measured: ICU day 7
upper limb muscle thickness
With the upper limb lying flat, the measurement point is located at the lower two-thirds of the distance between the acromion and the antecubital fossa. The thickness measurement includes the biceps brachii and brachialis muscles, spanning from the superficial fascia of the biceps brachii to the uppermost part of the humerus. A 5-15 MHz linear array probe is placed perpendicular to the humerus, applying minimal probe pressure to avoid deformation of subcutaneous fat and muscle.
Measured: ICU day 7
New infection in ICU
Incidence of New Infections in the ICU After 48 Hours of Admission Definition: The occurrence of new infections in the ICU, diagnosed after 48 hours of ICU admission, as confirmed by clinical, laboratory, or imaging criteria. Infections include but are not limited to ventilator-associated pneumonia (VAP), catheter-related bloodstream infections (CRBSI), and urinary tract infections (UTI). The observation period will be from 48 hours after ICU admission to ICU discharge, with a maximum assessment period of 90 days.
Measured: From 48 hours after ICU admission to ICU discharge, assessed up to 90 days
Length of ICU stay
Length of ICU Stay Definition: The duration of stay in the ICU, measured in days, from the date of ICU admission to the date of ICU discharge. The maximum observation period will be 90 days.
Measured: ICU stay
ventilator-free days
The number of days in the ICU during which no ventilator was used
Measured: ICU day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start25 Feb 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827275
- Sponsor's protocol ID
- mNEEDstudy2025
- Other IDs
- 320.6750.2024-25-6
- Acronym
- mNEED
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41281994
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06827275
- Acronym / sponsor ID
- mNEED / mNEEDstudy2025
- Keywords
- Nutritional support, prognosis, Feeding intolerance, Intensive care unit, Enteral nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,250 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| mNEED | Experimental | Procedure: Feeding processmNEED special feeding procedures set by the experimental group |
| guideline | Active comparator | Procedure: Feeding processFeeding according to the current 2023 ESPEN guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feeding processNutritional therapy is administered according to the feeding procedure | Procedure or surgery | guideline, mNEED |
Primary outcome
Feeding intolerance
Time frame: Within 7 days in the ICU
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.
12 secondary outcomes
Nutrition goal achievement
Time frame: ICU day 7
28-day mortality rate
Time frame: Day 28 after ICU admission
90-day mortality
Time frame: Day 90 after ICU admission
SF-36 (Short Form-36 Health Survey)
Time frame: Day 28 and 90 after ICU admission
EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Time frame: Day 28 and 90 after ICU admission
diaphragm thickness
Time frame: ICU day 7
quadriceps thickness
Time frame: ICU day 7
rectus femoris cross-sectional area
Time frame: ICU day 7
upper limb muscle thickness
Time frame: ICU day 7
New infection in ICU
Time frame: From 48 hours after ICU admission to ICU discharge, assessed up to 90 days
Length of ICU stay
Time frame: ICU stay
ventilator-free days
Time frame: ICU day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Derived from this study: PubMed 41281994Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeding process in people with Feeding and ICU, run by The First Hospital of Jilin University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong Zhang (+86 155 8429 9391, zhangdong@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feeding intolerance (time frame: Within 7 days in the ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06827275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.