The Effect of Oral and Nasal Feeding on Cerebral Small Vessel Disease

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• Cerebral Small Vessel Diseases 121

Study arms

• Experimental
  The observation group

  Assigned 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.

  Device: Intermittent Oro-esophageal Tube Feeding · Behavioral: comprehensive rehabilitation therapy

• Active comparator
  The control group

  Assigned 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.

  Device: Nasogastric Tube Feeding · Behavioral: comprehensive rehabilitation therapy

Interventions

• DeviceNasogastric Tube Feeding

  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.

• DeviceIntermittent Oro-esophageal Tube Feeding

  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.

• Behavioralcomprehensive rehabilitation therapy

  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.

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).

   Time frame: day 1 and day 15

Secondary outcomes

1. Functional Oral Intake Scale

   During Dysphagia-Functional Oral Intake Scale assessment, evaluators engage in communication with the patient, conduct observations, and make records to assess the patient's oral intake ability. The FOIS assessment form includes seven levels of scoring, ranging from level 1 to level 7, indicating a progressive improvement in the patient's oral intake ability. In general, the result below level 6 indicates unsafe for oral intake while level 6 and above indicates that eating via mouth can be safely conducted.

   Time frame: day 1 and day 15

2. Body mass index

   Weight and height will be combined to report Body mass index in kg/m\^2

   Time frame: day 1 and day 15

3. Serum albumin

   Serum albumin was recorded via blood routine test.(Alb, g/L)

   Time frame: day 1 and day 15

4. Hemoglobin

   Hemoglobin was recorded via blood routine test.(Hb, mg/L)

   Time frame: day 1 and day 15

5. Pneumonia

   The occurrence of pneumonia in patients was assessed before and after treatment. Specifically, first of all, the symptom assessment and physical examination were conducted to all patients, during which, the doctor would inquire symptoms related to pneumonia, such as cough, sputum production, difficulty breathing, chest pain, etc. and observe the patient's respiratory condition, including respiratory rate, breath sounds, and any abnormal signs in the chest. If there was probability for potential pneumonia, patients were requested for further diagnosis

   Time frame: day 1 and day 15

6. Activities of daily living

   The activities of daily living was assessed utilizing the Modified Barthel Index (MBI). Modified Barthel Index includes the following 10 subscales. For each subscale, choices encoded with the score 10, 8, 5, 2, 0 are set with the decreasing level of self-dependence, while the final total is positively correlated with Activities of daily living. Cronbach's α of questionnaire adopted is 0.916.

   Time frame: day 1 and day 15

7. World Health Organization Quality of Life Assessment Instrument Brief Version

   The Quality of Life was assessed utilizing the World Health Organization Quality of Life Assessment Instrument Brief Version (WHOQOL-BREF). WHOQOL-BREF covers various aspects such as mobility, pain, emotions, personal relationships, living conditions, and access to health services, to evaluate Quality of Life. Each item is rated on a Likert scale, and the scores are transformed into a standardized score ranging from 0 to 100, with higher scores indicating better Quality of Life

   Time frame: day 1 and day 15

Individual participant data

Plan to share: No