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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
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.
All-cause mortality
Time frame: 90 days post-randomization
90-day unfavorable outcome rate
Defined as a modified Rankin Scale (mRS) score of 3-6
Time frame: at 90 days
Neurological deficit score
National Institutes of Health Stroke Scale (NIHSS) score
Time frame: at Day 3 and Day 7 post-randomization
Activities of daily living
Barthel Index (BI)
Time frame: 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)
Time frame: Baseline and Day 7 assessments
Incidence of gastrointestinal intolerance
Gastric retention; diarrhea; constipation and gastrointestinal bleeding
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).
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