Intermittent Multifunctional Nutrition Tube in Cerebral Palsy and Dysphagia
- Conditions
- Cerebral Palsy
- Interventions
- Behavioral: systemic therapyDevice: Intermittent Oro-Esophageal Tube FeedingDevice: Persistent Nasogastric Tube Feeding
- Registration Number
- NCT06269835
- Lead Sponsor
- Zeng Changhao
- 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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The control group 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.The control group was given nutrition support with persistent nasogastric tube feeding , of which the tube passed through the nasal cavity into the stomach. The observation group 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. The observation group 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.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. The control group 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.
- Primary Outcome Measures
Name Time Method The Oral Motor Assessment Scale day 1 and day 90 The Oral Motor Assessment Scale was a reliable and accurate scale. It consists of seven items compromising oral-motor skills. The assessment was conducted with the child in comfortable supported sitting with the head neutral position. The caregiver was allowed to feed the child one of the following foods normally: fed with a spoon soft food as yoghurt, a solid food as cookie or fed a liquid food with a glass, with/without a straw. The assessment primarily focused on feeding with 5 types of food (mash, semi-solids, solids, cracker, and liquid bottle/cup). Throughout the assessment, the examiner didn't interfere with the way the caregiver fed the child but just observed and scored each item of feeding process including chewing, sucking and swallowing. Each item of The Oral Motor Assessment Scale takes 30 second to be scored as passive (0), sub-functional (1), semi-functional (2) and functional (3). The final score was positively proportional to swallowing function.
- Secondary Outcome Measures
Name Time Method Hemoglobin day 1 and day 90 The examination of hemoglobin levels will be conducted through a complete blood count (CBC) test.
Prealbumin day 1 and day 90 The examination of Prealbumin levels will be conducted through a complete blood count (CBC) test.
Pneumonia day 1 and day 90 The number of cases of pneumonia in the two groups was respectively recorded at admission and after treatment. The criteria for pneumonia are: the presence of respiratory infection symptoms such as cough, sputum, fever, and confirmation of inflammatory manifestations by lung CT.
Penetration-Aspiration Scale day 1 and day 90 Penetration-Aspiration Scale is an 8-point scale that measures selected aspects of airway penetration and aspiration. The score is determined primarily by the depth to which material passes in the airway and whether material entering the airway is expelled. The scores were negative correlated with the swallowing function
Total Protein day 1 and day 90 The examination of Total Protein levels will be conducted through a complete blood count (CBC) test.
Albumin day 1 and day 90 The examination of Albumin levels will be conducted through a complete blood count (CBC) test.
body weight day 1 and day 90 body weight was assessed with weight scale
Feeding amount day 1, day 11, day 21, day 31, day 41, day 51, day 61, day 71, day 81 and day 90 The volume of all nutrients obtained by the pediatric patients through tube feeding on the same day would be recorded, excluding water, unit: milliliter.
Functional Oral Intake Scale for Infants day 1 and day 90 The Functional Oral Intake Scale for Infants was also used to assess the feeding and swallowing abilities of infants. The The Functional Oral Intake Scale for Infants provided a systematic framework for evaluating an infant's level of oral intake. The minimum values are 0 and maximum values are 7, and higher scores mean a better outcome, better swallowing ability.
upper arm circumference day 1 and day 90 upper arm circumference was assessed with the tape.
Trial Locations
- Locations (1)
Center Rehabilitation Hospital
🇰🇷Seoul, Korea, Republic of