Intermittent Multifunctional Nutrition Tube Versus Persistent Nasogastric Tube Feeding in Infants With Cerebral Palsy and Dysphagia: A Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Palsy
- Sponsor
- Zeng Changhao
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The Oral Motor Assessment Scale
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Zeng Changhao
Head of R&D
People's Hospital of Zhengzhou University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
The Oral Motor Assessment Scale
Time Frame: 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 Outcomes
- Prealbumin(day 1 and day 90)
- Pneumonia(day 1 and day 90)
- Hemoglobin(day 1 and day 90)
- Penetration-Aspiration Scale(day 1 and day 90)
- body weight(day 1 and day 90)
- Total Protein(day 1 and day 90)
- Albumin(day 1 and day 90)
- Feeding amount(day 1, day 11, day 21, day 31, day 41, day 51, day 61, day 71, day 81 and day 90)
- Functional Oral Intake Scale for Infants(day 1 and day 90)
- upper arm circumference(day 1 and day 90)