Intermittent Multifunctional Nutrition Tube in Cerebral Palsy and Dysphagia

Zeng Changhao

Status: Enrolling

Conditions: Cerebral Palsy

Treatments: Device: Persistent Nasogastric Tube Feeding; Device: Intermittent Oro-Esophageal Tube Feeding; Behavioral: systemic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06269835

NAOTAN-IOE

Details and patient eligibility

About

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.

Full description

In China, for nutrition support in the infants under one year of age with cerebral palsy and dysphagia, persistent nasogastric tube feeding is the mainstream choice. However, the efficacy of persistent nasogastric tube feeding is not sufficiently satisfactory, necessitating the exploration for a more effective and safe nutrition support approach. Therefore, this study reports the clinical effect of intermittent oro-esophageal tube feeding compared to persistent nasogastric tube feeding in the infants with cerebral palsy and dysphagia who received systemic therapy.

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• meeting the diagnostic criteria of cerebral palsy formulated by the 13th National Conference on Pediatric Cerebral Palsy Rehabilitation;
• 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 dysphagia caused by other diseases or factors;
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

The observation group

Experimental group

Description:

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.

Treatment:

Behavioral: systemic therapy

Device: Intermittent Oro-Esophageal Tube Feeding

The control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: systemic therapy

Device: Persistent Nasogastric Tube Feeding