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
1 other identifier
interventional
174
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 stroke
Started Jun 2026
Shorter than P25 for phase_4 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2026
CompletedFirst Posted
Study publicly available on registry
June 5, 2026
CompletedStudy Start
First participant enrolled
June 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 15, 2027
June 5, 2026
May 1, 2026
1 year
May 27, 2026
June 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Hospital length of stay
From date of admission to date of discharge, assessed up to 28 days
90-day modified Rankin Scale (mRS) score
90 days after randomization
Time from admission to achieving enteral nutrition target
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
Baseline and Day 14
Change from baseline in serum albumin level at Day 28
Baseline and Day 28
- +2 more secondary outcomes
Other Outcomes (15)
Mortality within 28 days
28 days post-randomization.
Incidence of Gastrointestinal Complications
28 days
Catheter-related Complications
28 days
- +12 more other outcomes
Study Arms (2)
Post-Pyloric Feeding Group
EXPERIMENTALA 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
Gastric Feeding Group
ACTIVE COMPARATORA 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.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jinling Hospital, Medical School of Nanjing University, Nanjing
Nanjing, Jiangsu, 210002, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wusheng Zhu, MD
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Neurology
Study Record Dates
First Submitted
May 27, 2026
First Posted
June 5, 2026
Study Start
June 15, 2026
Primary Completion (Estimated)
June 16, 2027
Study Completion (Estimated)
September 15, 2027
Last Updated
June 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
Patient information will be de-identified