NCT03648255已完成不适用
A Prospective, Observational Study to Evaluate Gastrointestinal Symptoms and Safety of an Enteral Feeding Product in Pediatric Patients With Cerebral Palsy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 19
- 主要终点
- Gastro-Intestinal Tolerance
研究概览
简要总结
This prospective, observational, multi-center study will follow children with cerebral palsy who decided to switch to an enteral product that contains partially hydrolyzed protein and medium chain triglycerides as a result of clinical symptoms/diagnosis of gastrointestinal intolerance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cerebral palsy
- •Fed with an enteral product that does not contain partially hydrolyzed protein and medium chain triglycerides and decided to be switched to an enteral product contains partially hydrolyzed protein and medium chain triglycerides as a result of clinical symptoms/diagnosis of gastrointestinal intolerance
- •Fed by tube, using enteral tube feeding as sole source of nutrition
- •A signed and dated informed consent by subject's legally acceptable representative
排除标准
- •Chronic diseases other than cerebral palsy (e.g. diabetes mellitus, renal, liver, endocrine diseases, malignancy)
- •Intestinal obstruction
- •Dialysis treatment
- •Requirement of artificial ventilation
- •Requirement of parenteral nutrition
- •Normal nutrition in addition to enteral tube feeding
- •Allergy or intolerance to any ingredient of the study product
- •Currently participating in another clinical or non-clinical study
结局指标
主要结局
Gastro-Intestinal Tolerance
时间窗: Baseline to 6 months
healthcare professional assessed
次要结局
- Anthropometrics(Baseline to 6 months)
- Care Giver Satisfaction of Enteral Product(Baseline to 6 months)
研究者
研究点 (19)
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