Effect of Intermittent Enteral Feeding in Severe Stroke

Official title

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

Overview

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.

Interventions

• Behavioral 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.
• Behavioral 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.

Primary outcome measures

• All-cause mortality [Time frame: 90 days post-randomization]

Secondary outcome measures (6)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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

Identifiers

NCT: NCT07353658 · KY20252538jiangwen

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗