Oral Enteral Nutrition in Infants With Cerebral Palsy and Dysphagia

NCT ID: NCT06303934

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

systemic therapy+Intermittent Oro-Esophageal Tube Feeding

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.

Group Type: EXPERIMENTAL

systemic therapy

Intervention Type: BEHAVIORAL

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

Intervention Type: DEVICE

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.

systemic therapy+Persistent Nasogastric Tube Feeding

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.

Group Type: ACTIVE_COMPARATOR

systemic therapy

Intervention Type: BEHAVIORAL

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

Intervention Type: DEVICE

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

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.

Intervention Type: BEHAVIORAL

Intermittent Oro-Esophageal Tube Feeding

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.

Intervention Type: DEVICE

Persistent Nasogastric Tube Feeding

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• meeting the diagnostic criteria of cerebral palsy.
• 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muhammad

OTHER

Sponsor Role: lead

Responsible Party

Muhammad

Research Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nieto Luis, Master

Role: STUDY_CHAIR

Site Coordinator of United Medical Group

Locations

River First Hos.

Pingdong, , Taiwan

Countries

Taiwan

Other Identifiers

IOE-NT

Identifier Type: -

Identifier Source: org_study_id