Effectiveness of a New Neuromuscular Electrical Stimulation (NMES) Treatment Technique (VitalStim® Therapy) in the Management of Young Infants With Severe Dysphagia: a Prospective Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Effectiveness
研究概览
简要总结
The goal of this study is to obtain data that well help inform the feasibility and design of a randomized control trial of the therapeutic Neuromuscular Electrical Stimulation (NMES) technique in improving the swallowing function of young infants presenting with severe dysphagia.
详细描述
Infants with severe neurologic disability often have difficulty in eating by mouth due to a disruption in the swallowing process. This swallowing dysfunction, also known as dysphagia, is often evident early in life and when severe can be permanent. Dysphagia can lead to an inability to take in enough food to maintain an adequate weight and result in malnutrition. It also can result in food going into the lungs instead of the stomach, resulting in an illness called aspiration pneumonia. Both of these complications may require feeding by tube either through the nose into the stomach or directly into the stomach via the abdominal wall, to bypass the swallowing process. This process is resource intense, can be associated with a number of complications and may result in a reduced quality of life for both the infant and caregivers. Currently, there are no effective treatments to change the natural course of dysphagia in this context.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Weeks 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with severe dysphagia on VFFS as defined by dysphagia resulting in aspiration with swallow of at least 2 food textures (e.g. thin and thick liquid).
- •We will include children with dysphagia due to a central neurologic deficit. The neurologic diagnosis will be based on the diagnosis from the treating physician.
排除标准
- •Infants with a known or suspected neurodegenerative or peripheral neuromuscular condition or a medical condition that is a contraindication for NMES treatment (tumours in the neck region and neck soft tissue infections).
- •Children with neurodegenerative disorders have been excluded as their natural history of dysphagia would be different from those with a static neurologic disorder.
结局指标
主要结局
Effectiveness
时间窗: 4 months
The primary outcome will be an improvement in swallowing function as determined by videofluoroscopic feeding study from baseline to end of treatment (4 months after baseline). The swallowing function will be graded as to the number of textures the infant can safely swallow at three measurement points (baseline, 2 months and 4 months). An improvement in the number of textures the infant can swallow will define improvement. This will be recorded using a standard reporting form.
次要结局
- Resolution of dysphagia(4 months)
- Safety and Adverse events(duration of subjects involvment in the study)
- Feeding ability(baseline, 2 months and 4 months from enrollment)
- Oral feeding ability and need for tube feeding(baseline, 2 months, 4 months from enrollment)
- Hospitalizations for lower respiratory tract illness(4 months)
- Caregiver acceptability and perception of feeding(at 4 months)
- Data on treatment procedures(4 months)
研究者
Sanjay Mahant
Staff Physician
The Hospital for Sick Children