Intermittent Multifunctional Nutrition Tube in Cerebral Palsy and Dysphagia
NCT ID: NCT06269835
Last Updated: 2024-03-06
Study Results
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Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-02-28
2024-12-31
Brief Summary
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Detailed Description
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Method This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding, n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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The observation group
All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training.Within 4 hours of admission, the observation group were required to undergo nasogastric tube removal and initiated Intermittent Oro-Esophageal Tube Feeding for nutrition support.
systemic therapy
All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development\[. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training, as follows The mendelson maneuver: performed 5 days per week, twice per day, 5-10 minutes each time.
Cold stimulation of the pharynx: performed every day, twice per day, 3-5 minutes each time.
Passive head extension: to stretch the submental muscle for 2-3 seconds, with upward resistance applied to the lower cheek for no less than 5 times a day and no less than 5 minutes each time.
Direct feeding training: with powdered milk, once a day, 5 days a week.
Intermittent Oro-Esophageal Tube Feeding
Within 4 hours of admission, the observation group were required to undergo nasogastric tube removal and initiated Intermittent Oro-Esophageal Tube Feeding for nutrition support. Before each feeding, the infant should rest for approximately 1 hour and undergo oral clean. During feeding, the infant should be held by the caregiver in a semi-reclined or upright position. Firstly, the tail of the tube was inserted via mouth into the upper part of the esophagus with a depth of 18-20cm, and the external part of the tube should be placed in water with the absence of bubbles indicating the successful tube placement. Subsequently, 1ml of water was slowly injected, followed by liquid food or water at a rate of approximately 50ml/min through a syringe connected to the feeding tube. After feeding, the tube should be slowly removed, and the feeding position should be maintained for 30-60 minutes to prevent reflux.
The control group
All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training.The control group was given nutrition support with persistent nasogastric tube feeding , of which the tube passed through the nasal cavity into the stomach.
systemic therapy
All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development\[. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training, as follows The mendelson maneuver: performed 5 days per week, twice per day, 5-10 minutes each time.
Cold stimulation of the pharynx: performed every day, twice per day, 3-5 minutes each time.
Passive head extension: to stretch the submental muscle for 2-3 seconds, with upward resistance applied to the lower cheek for no less than 5 times a day and no less than 5 minutes each time.
Direct feeding training: with powdered milk, once a day, 5 days a week.
Persistent Nasogastric Tube Feeding
The control group was given nutrition support with Persistent Nasogastric Tube Feeding, of which the tube passed through the nasal cavity into the stomach. After successful intubation, the tube was secured on the cheek. Liquid food was then syringe-fed into the stomach and the feeding was conducted every 2-3 hours, with each meal not exceeding 200 ml. The daily intake was generally consistent with that of the observation group. Besides, after successful intubation, the tube was secured on the infant's face and changed every one to two weeks.
Interventions
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systemic therapy
All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development\[. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training, as follows The mendelson maneuver: performed 5 days per week, twice per day, 5-10 minutes each time.
Cold stimulation of the pharynx: performed every day, twice per day, 3-5 minutes each time.
Passive head extension: to stretch the submental muscle for 2-3 seconds, with upward resistance applied to the lower cheek for no less than 5 times a day and no less than 5 minutes each time.
Direct feeding training: with powdered milk, once a day, 5 days a week.
Intermittent Oro-Esophageal Tube Feeding
Within 4 hours of admission, the observation group were required to undergo nasogastric tube removal and initiated Intermittent Oro-Esophageal Tube Feeding for nutrition support. Before each feeding, the infant should rest for approximately 1 hour and undergo oral clean. During feeding, the infant should be held by the caregiver in a semi-reclined or upright position. Firstly, the tail of the tube was inserted via mouth into the upper part of the esophagus with a depth of 18-20cm, and the external part of the tube should be placed in water with the absence of bubbles indicating the successful tube placement. Subsequently, 1ml of water was slowly injected, followed by liquid food or water at a rate of approximately 50ml/min through a syringe connected to the feeding tube. After feeding, the tube should be slowly removed, and the feeding position should be maintained for 30-60 minutes to prevent reflux.
Persistent Nasogastric Tube Feeding
The control group was given nutrition support with Persistent Nasogastric Tube Feeding, of which the tube passed through the nasal cavity into the stomach. After successful intubation, the tube was secured on the cheek. Liquid food was then syringe-fed into the stomach and the feeding was conducted every 2-3 hours, with each meal not exceeding 200 ml. The daily intake was generally consistent with that of the observation group. Besides, after successful intubation, the tube was secured on the infant's face and changed every one to two weeks.
Eligibility Criteria
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Inclusion Criteria
* age\<1 year;
* diagnosed as dysphagia confirmed by Dysphagia Disorder Survey or pediatric esophagoscopy;
* with a nasogastric tube inserted at admission;
* enteral nutrition support is required and feasible.
Exclusion Criteria
* with progressive neurological disease or degenerative neurological disease;
* with severe heart disease, liver or kidney dysfunction, hematological disorders, or other acute and severe symptoms;
* with abnormalities in the oral cavity, pharynx, esophagus, or other parts of the digestive tract;
* with poor compliance.
6 Months
12 Months
ALL
No
Sponsors
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Zeng Changhao
OTHER
Responsible Party
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Zeng Changhao
Head of R&D
Principal Investigators
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Nieto Luis, Master
Role: STUDY_CHAIR
Site Coordinator of United Medical Group
Locations
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Center Rehabilitation Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Wei Liu, Master
Role: primary
Other Identifiers
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NAOTAN-IOE
Identifier Type: -
Identifier Source: org_study_id
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