Effect of Intermittent Enteral Feeding in Severe Stroke

Официальное название

The Effect of Intermittent Versus Continuous Enteral Feeding on Outcomes in Severe Stroke: An Exploratory Study

Обзор

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.

Вмешательства

• Поведенческое Intermittent Enteral Feeding
  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.
• Поведенческое Continuous Enteral Feeding
  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.

Первичные конечные точки

• All-cause mortality [Срок оценки: 90 days post-randomization]

Вторичные конечные точки (6)

• 90-day unfavorable outcome rate [Срок оценки: at 90 days]
• Neurological deficit score [Срок оценки: at Day 3 and Day 7 post-randomization]
• Activities of daily living [Срок оценки: 90 days post-randomization]
• Nutritional status indicators [Срок оценки: Baseline and Day 7 assessments]
• Incidence of gastrointestinal intolerance [Срок оценки: Throughout the intervention period (expected ≥7 days)]
• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Throughout the study period (up to 90-day follow-up).]

Критерии участия

Критерии включения

• Age ≥18 years old
• It was definitely diagnosed as acute stroke by clinical imaging.
• Enteral nutrition program can be started within 72 hours of onset.
• Baseline GCS≤12 or NIHSS≥11
• There is nutritional risk (NRS 2002≥3), Wadian drinking water test≥ 3 or there is consciousnessdisorder,it is estimated that you need to receive nutritional support treatment for ≥7 days
• Obtain informed consent

Критерии исключения

• Before joining the group, he had received total parenteral nutrition treatment.
• There are contraindications to enteral nutrition.
• Unstable vital signs
• Dementia or severe disability before onset (mRS≥3)
• There are concomitant diseases that will interfere with outcome evaluation and/or follow-up.
• Participating in other interventional clinical trials.
• Other circumstances in which the study cannot be completed.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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, P PMID 36958363
• 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 PMID 35219379
• 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. PMID 40516326
• 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. PMID 32152512
• 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. PMID 25992505
• 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. PMID 21705881
• 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. PMID 32863747
• 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. PMID 36703642

Идентификаторы

NCT: NCT07353658 · KY20252538jiangwen

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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