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NCT Number: NCT07630090

Gastric Feeding for the Prevention of Stroke-Associated Pneumonia

This randomized controlled trial aims to compare the effectiveness of early post-pyloric feeding versus gastric feeding in preventing SAP in patients with severe ischemic stroke. The main question to answer is whether post-pyloric feeding group is better than the gastric feeding group for preventing SAP.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

This study adopts a multicenter-center, randomized controlled, parallel-group, open-label trial design. Patients with severe ischemic stroke who meet the inclusion criteria will be randomly assigned to the post-pyloric feeding group (experimental group) or the gastric feeding group (control group). Both groups will receive standard stroke treatment and care. The primary outcome measure is the incidence of SAP, with a follow-up period of 90 days. The sample size is 174 cases, with 87 cases per group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Diagnosis of severe ischemic stroke, with NIHSS score > 16 [15-16]
  • Confirmed dysphagia via swallowing assessment (Kubota Water Swallowing Test ≥ grade 3, or confirmed aspiration risk by FEES/VFSS)
  • Time from onset to enrollment ≤ 72 hours
  • Expected survival ≥ 7 days
  • Non-mechanically ventilated patients
  • Signed informed consent from patient or legal representative.

Exclusion criteria

  • Diagnosed with pneumonia upon admission
  • High risk of gastrointestinal bleeding or perforation
  • Intestinal obstruction or gastrointestinal obstruction
  • Severe liver or kidney dysfunction
  • Advanced malignant tumor
  • Pregnancy or breastfeeding
  • Refusal to participate in the study

Treatment and study plan

Post-Pyloric Feeding

Procedure

A nasoenteric tube (Nuritia, 10Fr) will be placed within 24 hours of admission. The procedure involves elevating the head of the bed to approximately 30-45°, lubricating the tube with liquid paraffin, inserting it into the stomach using a blind insertion technique, then positioning the patient in the right lateral decubitus position. The insertion length will be approximately 75 cm. 200-500 ml of air and warm water will be injected into the stomach to open the pylorus. Gently, as the pylorus opens, the tube will be advanced beyond the ligament of Treitz. Digestive fluid will be aspirated for pH testing. Tube position (post-pyloric) will be confirmed by X-ray before initiating enteral nutrition support. An appropriate nutritional formula will be selected based on the patient's condition. The initial infusion rate will be 20 ml/h using a nutrition pump. The head of the bed will be elevated to 30-45°. Observation will occur continuously for the first hour, then every 4 hours. The rate wil

Gastric Feeding

Procedure

A nasogastric tube (Nuritia, 14Fr) will be placed within 24 hours of admission. The tube will be lubricated with liquid paraffin, inserted into the gastric cavity using a blind insertion technique, and properly fixed. Correct position will be confirmed by auscultation of air insufflation over the stomach before initiating enteral nutrition support. An appropriate nutritional formula will be selected based on the patient's condition. The initial infusion rate will be 20 ml/h using a nutrition pump. The head of the bed will be elevated to 30-45°. Observation will occur continuously for the first hour, then every 4 hours. The rate will be gradually increased by 10 mL every 4 hours based on patient tolerance until the daily target volume (25-30 kcal/kg/day) is achieved.

Primary outcomes

  1. Incidence of stroke-associated pneumonia within 7 days of onset

    Time frame: 7 days of onset.

    The diagnostic criteria for SAP will follow the 2019 Chinese Expert Consensus on the Diagnosis and Treatment of Stroke-Associated Pneumonia.

Secondary outcomes

  1. Hospital length of stay

    Time frame: From date of admission to date of discharge, assessed up to 28 days

    Length of patients stay in the hospital

  2. 90-day modified Rankin Scale (mRS) score

    Time frame: 90 days after randomization

    The distribution of the 90-day mRS (0;1;2;3;4;5;6) as assessed by structured assessment.

  3. Time from admission to achieving enteral nutrition target

    Time frame: From date of admission until enteral nutrition target is achieved, assessed up to 28 days

    Enteral nutrition target is set as 25-30kcal/kg.

  4. Change from baseline in serum albumin level at Day 14

    Time frame: Baseline and Day 14

    Serum albumin will be measured via venous blood sample.

  5. Change from baseline in serum albumin level at Day 28

    Time frame: Baseline and Day 28

    Serum albumin will be measured via venous blood sample

  6. Change from baseline in white blood cell count at Day 14

    Time frame: Baseline and Day 14

    White blood cell count will be measured via venous blood sample.

  7. Change from baseline in white blood cell count at Day 28

    Time frame: Baseline and Day 28

    White blood cell count will be measured via venous blood sample.

Other outcomes

  1. Mortality within 28 days

    Time frame: 28 days post-randomization.

    Percentage of patients who die within 28 days post-randomization.

  2. Incidence of Gastrointestinal Complications

    Time frame: 28 days

    Gastrointestinal bleeding, diarrhea, abdominal distension, constipation, vomiting.

  3. Catheter-related Complications

    Time frame: 28 days

    Blockage, displacement, dislodgement

  4. Change from baseline in serum total protein level at Day 14

    Time frame: Baseline and Day 14

    Serum total protein level will be measured via venous blood sample.

  5. Change from baseline in serum prealbumin level at Day 14

    Time frame: Baseline and Day 14

    Serum prealbumin level will be measured via venous blood sample.

  6. Change from baseline in serum transferrin level at Day 14

    Time frame: Baseline and Day 14

    Serum transferrin level will be measured via venous blood sample.

  7. Change from baseline in serum total protein level at Day 28

    Time frame: Baseline and Day 28

    Serum total protein will be measured via venous blood sample

  8. Change from baseline in serum prealbumin level at Day 28

    Time frame: Baseline and Day 28

    Serum prealbumin will be measured via venous blood sample

  9. Change from baseline in serum transferrin level at Day 28

    Time frame: Baseline and Day 28

    Serum transferrin will be measured via venous blood sample

  10. Change from baseline in C-reactive protein level at Day 14

    Time frame: Baseline and Day 14

    C-reactive protein will be measured via venous blood sample.

  11. Change from baseline in interleukin-6 level at Day 14

    Time frame: Baseline and Day 14

    Interleukin-6 level will be measured via venous blood sample.

  12. Change from baseline in body temperature at Day 14

    Time frame: Baseline and Day 14

    Body temperature will be recorded at 8:00 AM daily during the hospitalization.

  13. Change from baseline in interleukin-6 level at Day 28

    Time frame: Baseline and Day 28

    Interleukin-6 level will be measured via venous blood sample.

  14. Change from baseline in C-reactive protein level at Day 28

    Time frame: Baseline and Day 28

    C-reactive protein level will be measured via venous blood sample.

  15. Change from baseline in body temperature at Day 28

    Time frame: Baseline and Day 28

    Body temperature will be recorded at 8:00 AM daily during the hospitalization.

Study contacts

Contact information is provided by the study sponsor or research team.

Rui Liu, MD

CONTACT

[email protected]

+86 15005144515

Yahui Guo, MD

CONTACT

[email protected]

+86 13951834652

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Official study title

Comparing Early Post-pyloric Feeding Versus Gastric Feeding for the Prevention of Stroke-Associated Pneumonia in Patients With Severe Ischemic Stroke

Acronym: FEED-SAP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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