NCT02819401已完成不适用
A Prospective, Open-label, Post-marketing Observational Study to Evaluate the Effects of High-fiber Enteral Pediatric Formula in Children With Failure to Thrive Due to Malnutrition
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 345
- 试验地点
- 17
- 主要终点
- Physician Perception of Formula Use
研究概览
简要总结
The present study is designed to determine the gastrointestinal tolerability of enteral nutritional products, physicians and parents' overall perception of enteral nutrition products as well as providing basic demographic information on pediatric populations prescribed these formula for supportive treatment as part of the routine healthcare service in Turkey.
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 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age; 1-10 years (inclusive)
- •Children diagnosed as failure-to-thrive(FTT).
- •Children who have been recently prescribed and treatment initiated with isocaloric or hypercaloric high-fiber pediatric enteral formula suitable for oral and/or nasogastric tube feeding before inclusion in the study.
排除标准
- •Chronic renal disorder
- •Decompensated liver disease
- •Any other chronic condition that was not under control (e.g. diabetes, thyroid disorder, etc.)
- •Any type of malignant disease including leukemia and lymphoma
- •Cystic fibrosis
- •Short bowel syndrome
- •Any type of food allergy or intolerance
- •Growth hormone deficiency
- •Use of enteral feeding within the last 4 weeks
结局指标
主要结局
Physician Perception of Formula Use
时间窗: Baseline to Month 6
Questionnaire
次要结局
- Gastrointestinal Tolerance(Baseline to Month 1, Month 2, Month 4 and Month 6)
- Description of Population(Baseline)
- Weight(Baseline to Month 1, Month 2, Month 4 and Month 6)
研究者
研究点 (17)
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