Effect of Intermittent Enteral Feeding in Severe Stroke

Air Force Military Medical University of People's Liberation Army

Status: Not yet enrolling

Conditions: Severe Stroke; Enteral Nutrition

Treatments: Behavioral: Intermittent Enteral Feeding; Behavioral: Continuous Enteral Feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT07353658

KY20252538jiangwen

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years old
2. It was definitely diagnosed as acute stroke by clinical imaging.
3. Enteral nutrition program can be started within 72 hours of onset.
4. Baseline GCS≤12 or NIHSS≥11
5. 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
6. Obtain informed consent

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Intermittent Enteral Nutrition Group

Experimental group

Treatment:

Behavioral: Intermittent Enteral Feeding

Continuous Enteral Nutrition Group

Active Comparator group

Treatment:

Behavioral: Continuous Enteral Feeding