The Effect of Oral and Nasal Feeding on Cerebral Small Vessel Disease
A Randomized Controlled Study to Explore the Clinical The Effect of Oral and Nasal Feeding on Cerebral Small Vessel Disease
1 other identifier
interventional
88
1 country
1
Brief Summary
Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2024
Shorter than P25 for not_applicable
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
January 31, 2024
CompletedFirst Posted
Study publicly available on registry
February 8, 2024
CompletedStudy Start
First participant enrolled
February 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedMarch 12, 2024
March 1, 2024
2 months
January 31, 2024
March 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Video Fluoroscopic Swallowing Study
Video Fluoroscopic Swallowing Study, which is considered as the "gold standard", swallowing process is divided into four periods: cognitive, oral, pharyngeal, and esophageal periods with a total score of 10 and a higher score indicates better swallowing ability (less dysphagia).
day 1 and day 15
Secondary Outcomes (7)
Functional Oral Intake Scale
day 1 and day 15
Body mass index
day 1 and day 15
Serum albumin
day 1 and day 15
Hemoglobin
day 1 and day 15
Pneumonia
day 1 and day 15
- +2 more secondary outcomes
Study Arms (2)
The observation group
EXPERIMENTALAssigned by the random number table. During the treatment, all patients were provided with comprehensive rehabilitation therapy. Besides, the observation group was given enteral nutritional support with Intermittent Oro-esophageal Tube Feeding according to the relevant guidelines.
The control group
ACTIVE COMPARATORAssigned by the random number table. During the treatment, all patients were provided with comprehensive rehabilitation therapy. Besides, the control group was given enteral nutritional support with nasogastric tube according to the relevant guidelines. Within 4 hours after admission, the placement of the feeding tube was conducted by professional medical staffs and after intubation.
Interventions
Nasogastric Tube Feeding were used for feeding to provide nutritional support. Each feeding was administered by a nurse using the infant's mother's breast milk through the tube. The amount of each feeding varied from 20 to 100 ml depending on the age of the infant, with feedings given every 2 to 3 hours, approximately 10 times per day. The duration of each feeding procedure ranged from 10 to 20 minutes. The total daily intake ranged from 200 to 1000 ml. Each tube was kept indwelling for 5 to 7 days. When the tube needed to be replaced, it was removed after the last feeding of a day and a new tube was to be inserted through the other nostril on the following morning to continue the nutritional support.
The specific procedure was as follows: the infant was placed in a semi-recumbent or sitting position with the head fixed. Before each feeding, the infant's oral and nasal secretions were to be cleared. An intermittent oro-esophageal tube was appropriately lubricated with water on the head part. The professional medical staff held the tube and slowly inserted it through one side of the mouth into the upper part of the esophagus. The depth of insertion depended on the patient's age and height. After each feeding, the tube was immediately removed, and the patient was held upright for at least 30 minutes in case of reflux.
Both groups were given comprehensive rehabilitation therapy. The main intervention measures included: 1) non-invasive ventilator treatment, generally at least once every night and typically not exceeding continuous daily usage.; 2) attention to feeding and sleeping positions, with a recommended sleeping position of lateral recumbent and the head of the bed raised by 20-30°; 3) swallowing function training, such as tongue muscle stretching training, assisted anterior jaw protrusion training, lemon ice stimulation to the soft palate, pharyngeal wall, etc., generally 5 days per week, twice per day, 5-20 minutes each time; 4) pulmonary ultrashort wave therapy, generally at least 2-3 times a week, and not more than once a day; 5) physical therapy, such as intensive training for gross motor functions including lifting the head, turning over, sitting, crawling, standing, etc., generally 3-5 days per week, 1-2 times per day, 5-20 min each time.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Cerebral Small Vessel Disease;
- Must be able to cooperate with treatment and questionnaire investigation, (Generally with a Mini-Mental State Examination (MMSE) score ≥ 24) ;
- Clinical diagnosis of dysphagia through the Functional Oral Intake Scale (FOIS) and Video Fluoroscopic Swallowing Study (VFSS);
- Age between 40 and 70 years;
- Enteral nutrition support was required and feasible.
- No history of prior stroke.
You may not qualify if:
- Dysphagia related to other cerebrovascular diseases or caused by neurodegenerative diseases;
- Complicated with severe liver and kidney failure, tumors, or hematological disorders;
- Simultaneously need to undergo other therapy that might affect the outcomes of this study;
- Pregnant or nursing females.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zeng Changhaolead
Study Sites (1)
Ratchaburi Center Hos.
Ratchaburi, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nieto Luis, Master
Site Coordinator of United Medical Group located in Miami
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Director
Study Record Dates
First Submitted
January 31, 2024
First Posted
February 8, 2024
Study Start
February 15, 2024
Primary Completion
April 1, 2024
Study Completion
May 1, 2024
Last Updated
March 12, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share