Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-center, randomized, exploratory clinical trial investigating whether intermittent enteral feeding improves outcomes compared to continuous feeding in patients with severe stroke. The study will enroll 60 patients to evaluate the impact on 90-day all-cause mortality, neurological function, nutritional status, and safety. It will also explore underlying mechanisms through analysis of metabolic profiles, circadian gene expression, and gut microbiota.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent Enteral Nutrition Group | Experimental |
| |
| Continuous Enteral Nutrition Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Enteral Feeding | Behavioral | Participants randomized to this group will receive enteral nutrition via a nasogastric or nasojejunal tube using an intermittent, daytime-only feeding schedule designed to align with the physiological circadian rhythm. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 90 days post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 90-day unfavorable outcome rate | Defined as a modified Rankin Scale (mRS) score of 3-6 | at 90 days |
| Neurological deficit score | National Institutes of Health Stroke Scale (NIHSS) score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingjing Zhao | Contact | 18192829590 | zhaojing@126.com |
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36958363 | Result | Reignier J, Plantefeve G, Mira JP, Argaud L, Asfar P, Aissaoui N, Badie J, Botoc NV, Brisard L, Bui HN, Chatellier D, Chauvelot L, Combes A, Cracco C, Darmon M, Das V, Debarre M, Delbove A, Devaquet J, Dumont LM, Gontier O, Groyer S, Guerin L, Guidet B, Hourmant Y, Jaber S, Lambiotte F, Leroy C, Letocart P, Madeux B, Maizel J, Martinet O, Martino F, Maxime V, Mercier E, Nay MA, Nseir S, Oziel J, Picard W, Piton G, Quenot JP, Reizine F, Renault A, Richecoeur J, Rigaud JP, Schneider F, Silva D, Sirodot M, Souweine B, Tamion F, Terzi N, Thevenin D, Thiery G, Thieulot-Rolin N, Timsit JF, Tinturier F, Tirot P, Vanderlinden T, Vinatier I, Vinsonneau C, Voicu S, Lascarrou JB, Le Gouge A; NUTRIREA-3 Trial Investigators; Clinical Research in Intensive Care; Sepsis (CRICS-TRIGGERSEP)Group. Low versus standard calorie and protein feeding in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group trial (NUTRIREA-3). Lancet Respir Med. 2023 Jul;11(7):602-612. doi: 10.1016/S2213-2600(23)00092-9. Epub 2023 Mar 20. | |
| 35219379 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Continuous Enteral Feeding | Behavioral | Participants randomized to this group will receive enteral nutrition via a nasogastric or nasojejunal tube using the standard, continuous 24-hour feeding method commonly employed in critical care settings. |
|
| at Day 3 and Day 7 post-randomization |
| Activities of daily living | Barthel Index (BI) | 90 days post-randomization |
| Nutritional status indicators | Serum albumin (ALB); Serum prealbumin (PAB); Serum total protein (TP); Hemoglobin (HB) levels; Mid-upper arm circumference (MUAC); Triceps skinfold thickness (TSF) | Baseline and Day 7 assessments |
| Incidence of gastrointestinal intolerance | Gastric retention; diarrhea; constipation and gastrointestinal bleeding | Throughout the intervention period (expected ≥7 days) |
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Throughout the study period (up to 90-day follow-up). |
| Result |
| Zhao J, Yuan F, Song C, Yin R, Chang M, Zhang W, Zhang B, Yu L, Jia Y, Ma Y, Song Y, Wang C, Song C, Wang X, Shang L, Yang F, Jiang W; OPENS Trial Investigators. Safety and efficacy of three enteral feeding strategies in patients with severe stroke in China (OPENS): a multicentre, prospective, randomised, open-label, blinded-endpoint trial. Lancet Neurol. 2022 Apr;21(4):319-328. doi: 10.1016/S1474-4422(22)00010-2. Epub 2022 Feb 24. |
| 40516326 | Result | Panwar R, Kumar N, Parikh H, Dash S, Rai S. Standard continuous feeding versus intermittent feeding among mechanically ventilated patients in intensive care: A systematic review and meta-analysis of randomized controlled trials. Clin Nutr. 2025 Aug;51:40-49. doi: 10.1016/j.clnu.2025.05.024. Epub 2025 Jun 7. |
| 32152512 | Result | Zhu W, Jiang Y, Li J. Intermittent versus continuous tube feeding in patients with hemorrhagic stroke: a randomized controlled clinical trial. Eur J Clin Nutr. 2020 Oct;74(10):1420-1427. doi: 10.1038/s41430-020-0579-6. Epub 2020 Mar 9. |
| 25992505 | Result | Arabi YM, Aldawood AS, Haddad SH, Al-Dorzi HM, Tamim HM, Jones G, Mehta S, McIntyre L, Solaiman O, Sakkijha MH, Sadat M, Afesh L; PermiT Trial Group. Permissive Underfeeding or Standard Enteral Feeding in Critically Ill Adults. N Engl J Med. 2015 Jun 18;372(25):2398-408. doi: 10.1056/NEJMoa1502826. Epub 2015 May 20. |
| 21705881 | Result | Heyland DK, Cahill N, Day AG. Optimal amount of calories for critically ill patients: depends on how you slice the cake! Crit Care Med. 2011 Dec;39(12):2619-26. doi: 10.1097/CCM.0b013e318226641d. |
| 32863747 | Result | Wong HJ, Harith S, Lua PL, Ibrahim KA. Prevalence and Predictors of Malnutrition Risk among Post-Stroke Patients in Outpatient Setting: A Cross-Sectional Study. Malays J Med Sci. 2020 Jul;27(4):72-84. doi: 10.21315/mjms2020.27.4.7. Epub 2020 Aug 19. |
| 36703642 | Result | van Wijk N, Studer B, van den Berg CA, Ripken D, Lansink M, Siebler M, Schmidt-Wilcke T. Evident lower blood levels of multiple nutritional compounds and highly prevalent malnutrition in sub-acute stroke patients with or without dysphagia. Front Neurol. 2023 Jan 10;13:1028991. doi: 10.3389/fneur.2022.1028991. eCollection 2022. |
| 41082009 | Result | Sharie SA, Almari R, Azzam S, Al-Husinat L, Araydah M, Battaglini D, Schultz MJ, Patroniti NA, Rocco PR, Robba C. Brain Protective Ventilation Strategies in Severe Acute Brain Injury. Curr Neurol Neurosci Rep. 2025 Oct 13;25(1):68. doi: 10.1007/s11910-025-01462-2. |
| 34838196 | Result | Ma Q, Li R, Wang L, Yin P, Wang Y, Yan C, Ren Y, Qian Z, Vaughn MG, McMillin SE, Hay SI, Naghavi M, Cai M, Wang C, Zhang Z, Zhou M, Lin H, Yang Y. Temporal trend and attributable risk factors of stroke burden in China, 1990-2019: an analysis for the Global Burden of Disease Study 2019. Lancet Public Health. 2021 Dec;6(12):e897-e906. doi: 10.1016/S2468-2667(21)00228-0. |
| 39304265 | Result | GBD 2021 Stroke Risk Factor Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Neurol. 2024 Oct;23(10):973-1003. doi: 10.1016/S1474-4422(24)00369-7. |
| 35230392 | Result | Walter K. What Is Acute Ischemic Stroke? JAMA. 2022 Mar 1;327(9):885. doi: 10.1001/jama.2022.1420. No abstract available. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |