Health TrialsbyHealthPanel

Effect of Intermittent Enteral Feeding in Severe Stroke

ConditionsSevere StrokeEnteral Nutrition
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXijing Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intermittent Enteral Nutrition GroupExperimental treatment 1 intervention
Group B: Continuous Enteral Nutrition GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

All-cause mortality

Time frame
90 days post-randomization

Secondary outcomes

1

90-day unfavorable outcome rate

Defined as a modified Rankin Scale (mRS) score of 3-6

Time frame
at 90 days
2

Neurological deficit score

National Institutes of Health Stroke Scale (NIHSS) score

Time frame
at Day 3 and Day 7 post-randomization
3

Activities of daily living

Barthel Index (BI)

Time frame
90 days post-randomization
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xijing Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: