Intermittent Multifunctional Nutrition Tube Versus Persistent Nasogastric Tube Feeding in Infants With Cerebral Palsy and Dysphagia: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- The Oral Motor Assessment Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intermittent Oro-Esophageal Tube Feeding+ 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.
干预措施: systemic therapy (Behavioral)
Intermittent Oro-Esophageal Tube Feeding+ 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.
干预措施: Intermittent Oro-Esophageal Tube Feeding (Device)
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.
干预措施: systemic therapy (Behavioral)
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.
干预措施: Persistent Nasogastric Tube Feeding (Device)
结局指标
主要结局
The Oral Motor Assessment Scale
时间窗: 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.
次要结局
- Prealbumin(day 1 and day 90)
- body weight(day 1 and day 90)
- Pneumonia(day 1 and day 90)
- Penetration-Aspiration Scale(day 1 and day 90)
- Hemoglobin(day 1 and day 90)
- Total Protein(day 1 and day 90)
- Albumin(day 1 and day 90)
- Functional Oral Intake Scale for Infants(day 1 and day 90)
- Feeding amount(day 1 and day 90)
研究者
Copka Sonpashan
The Research Director
Chao Phya Abhaibhubejhr Hospital