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In patients with severe stroke whose GCS score is ā¤12 points or NIHSS score is ā„11 points, to evaluate whether time-restricted enteral nutrition can improve the incidence of poor 90-day prognosis (mRS ā„3 points) compared with continuous enteral nutrition.
Control the daily enteral nutrition time to 8-12 hours, enteral nutrition start time: 06:00 ~ 08:00, end time: 16:00 ~ 18:00. Enteral nutrition lasts until the patient discontinues enteral nutrition, the patient dies, the patient is transferred from the ICU, or enteral nutrition is used until 28 days, whichever event occurs first.
On the first day of enrollment: the patient is given 1/3 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; On the second day of enrollment: the patient is given 1/2 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; Enrollment 3 - End of intervention: The patient is given 100% of the estimated energy through enteral nutrition, which can fluctuate between 70% and 100% of the estimated energy, and the protein is 1.2-1.5g/kg/d.
The control group was continuous enteral nutrition (24 hours), which lasted until the patient stopped taking enteral nutrition, the patient died, the patient was transferred from the ICU, or enteral nutrition was used until 28 days, whichever event occurred first.
On the first day of enrollment: the patient is given 1/3 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; On the second day of enrollment: the patient is given 1/2 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; Enrollment 3 - End of intervention: The patient is given 100% of the estimated energy through enteral nutrition, which can fluctuate between 70% and 100% of the estimated energy, and the protein is 1.2-1.5g/kg/d.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time-restricted group | Experimental | Time-restricted enteral nutrition therapy group |
|
| Continuous group | Other | Continuous enteral nutrition control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time-restricted enteral nutrition therapy group | Other | Control the daily enteral nutrition time to 8-12 hours, enteral nutrition start time: 06:00 ~ 08:00, end time: 16:00 ~ 18:00. Enteral nutrition lasts until the patient discontinues enteral nutrition, the patient dies, the patient is transferred from the ICU, or enteral nutrition is used until 28 days, whichever event occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Poor 90-day functional prognosis | mRS ā„ 3 points | Day 90 post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| GCS score at discharge | Glasgow Coma Scale,the score ranges from 3-15. The lower the score, the greater the impairment of consciousness | The day of Discharge, an average of 20 days |
| NIHSS score at discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events during hospitalization | Safety outcomes | From enrollment to discharge, an average of 20 days |
| Serious adverse events during hospitalization | Safety outcome |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tao Yu, doctor | First Affiliated Hospital of Wannan Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affliated hospital of Wannan medical college | Wuhu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41339081 | Derived | Yu T, Shi G, Ye Z, Jiang X, Jia W, Wang Y, Wang Y, Xu J. Rationale and design of a PROBE trial comparing continuous enteral nutrition to time-restricted enteral nutrition in severe stroke. Stroke Vasc Neurol. 2025 Dec 3:svn-2025-004382. doi: 10.1136/svn-2025-004382. Online ahead of print. |
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|
| Continuous enteral nutrition control group | Other | The control group was continuous enteral nutrition (24 hours), which lasted until the patient stopped taking enteral nutrition, the patient died, the patient was transferred from the ICU, or enteral nutrition was used until 28 days, whichever event occurred first. |
|
NIH Stroke Scale,the score ranges from 0~42 points, and the higher the score, the more severe the nerve damage
| The day of Discharge, an average of 20 days |
| mRS score at discharge | Modified Rankin Scaleļ¼the score ranges from 0~6 levels,and the higher the score, the more severe outcome | The day of Discharge, an average of 20 days |
| Barthel index at discharge | Barthel index at discharge | The day of Discharge, an average of 20 days |
| 90-day Barthel Index | 90-day Barthel Index | Day 90 post-randomization |
| ICU length of stay | ICU length of stay | From admission to ICU to transfer out of ICU .an average of 11 days |
| Length of hospital stay | total length of stay | The day of Discharge, an average of 20 days |
| From enrollment to discharge, an average of 20 days |
| 28-day mortality rate | Safety outcome | From enrollment to Day 28 post-randomization |
| 90-day mortality rate. | Safety outcome | From enrollment to Day 90 post-randomization |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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