Gastric Feeding for the Prevention of Stroke-Associated Pneumonia (FEED-SAP)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Procedure: Post-Pyloric Feeding; Procedure: Gastric Feeding

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 174
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yahui Guo, MD; Phone Number: +86 13951834652; Email: 1185626794@qq.com
• Study Contact Backup: Name: Rui Liu, MD; Phone Number: +86 15005144515; Email: liurui8616@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Jinling Hospital, Medical School of Nanjing University, Nanjing
      • Contact: Yahui Guo, MD; Phone Number: +86 13951834652; Email: 1185626794@qq.com
      • Contact: Rui Liu, MD; Phone Number: +86 15005144515; Email: liurui8616@163.com
      • Sub-Investigator: Yahui Guo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Post-Pyloric Feeding Group; 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 wi	Procedure: Post-Pyloric Feeding; 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
Active Comparator: Gastric Feeding Group; 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.	Procedure: Gastric Feeding; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of stroke-associated pneumonia within 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.	7 days of onset.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay	Length of patients stay in the hospital	From date of admission to date of discharge, assessed up to 28 days
90-day modified Rankin Scale (mRS) score	The distribution of the 90-day mRS (0;1;2;3;4;5;6) as assessed by structured assessment.	90 days after randomization
Time from admission to achieving enteral nutrition target	Enteral nutrition target is set as 25-30kcal/kg.	From date of admission until enteral nutrition target is achieved, assessed up to 28 days
Change from baseline in serum albumin level at Day 14	Serum albumin will be measured via venous blood sample.	Baseline and Day 14
Change from baseline in serum albumin level at Day 28	Serum albumin will be measured via venous blood sample	Baseline and Day 28
Change from baseline in white blood cell count at Day 14	White blood cell count will be measured via venous blood sample.	Baseline and Day 14
Change from baseline in white blood cell count at Day 28	White blood cell count will be measured via venous blood sample.	Baseline and Day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality within 28 days	Percentage of patients who die within 28 days post-randomization.	28 days post-randomization.
Incidence of Gastrointestinal Complications	Gastrointestinal bleeding, diarrhea, abdominal distension, constipation, vomiting.	28 days
Catheter-related Complications	Blockage, displacement, dislodgement	28 days
Change from baseline in serum total protein level at Day 14	Serum total protein level will be measured via venous blood sample.	Baseline and Day 14
Change from baseline in serum prealbumin level at Day 14	Serum prealbumin level will be measured via venous blood sample.	Baseline and Day 14
Change from baseline in serum transferrin level at Day 14	Serum transferrin level will be measured via venous blood sample.	Baseline and Day 14
Change from baseline in serum total protein level at Day 28	Serum total protein will be measured via venous blood sample	Baseline and Day 28
Change from baseline in serum prealbumin level at Day 28	Serum prealbumin will be measured via venous blood sample	Baseline and Day 28
Change from baseline in serum transferrin level at Day 28	Serum transferrin will be measured via venous blood sample	Baseline and Day 28
Change from baseline in C-reactive protein level at Day 14	C-reactive protein will be measured via venous blood sample.	Baseline and Day 14
Change from baseline in interleukin-6 level at Day 14	Interleukin-6 level will be measured via venous blood sample.	Baseline and Day 14
Change from baseline in body temperature at Day 14	Body temperature will be recorded at 8:00 AM daily during the hospitalization.	Baseline and Day 14
Change from baseline in interleukin-6 level at Day 28	Interleukin-6 level will be measured via venous blood sample.	Baseline and Day 28
Change from baseline in C-reactive protein level at Day 28	C-reactive protein level will be measured via venous blood sample.	Baseline and Day 28
Change from baseline in body temperature at Day 28	Body temperature will be recorded at 8:00 AM daily during the hospitalization.	Baseline and Day 28

Collaborators and Investigators

• Sponsor: Jinling Hospital, China
• Investigators: Principal Investigator: Wusheng Zhu, MD, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 16, 2027
• Study Completion (Estimated): September 15, 2027

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: NIHSS; severe stroke; stroke-associated pneumonia; Gastric Feeding; Post-Pyloric Feeding
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Therapeutics; Nutrition Therapy; Feeding Methods; Nutritional Support; Enteral Nutrition
• Other Study ID Numbers: FEED-SAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient information will be de-identified

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No