NCT01469117已完成不适用
Enteral Formula Tolerance In Pediatric Patients With Developmental Disabilities
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2011年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Time to feeding goal achievement
研究概览
简要总结
This is a single center, prospective, non-randomized, uncontrolled, observational study of the use of an enteral nutrition product in pediatric patients with developmental disabilities.
详细描述
This prospective observational study seeks to assess ability to achieve enteral feeding goals with a new tube feeding product in pediatric patients with developmental disabilities.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child aged 1-13 years old with development disabilities
- •Currently tolerating enteral feeding
- •Requiring nutritional management to meet 50-90th% weight for age on the Kennedy Kreiger Growth Charts
- •Requires enteral tube feeding for at least 14 days.
排除标准
- •Unable to access gastrointestinal tract for feeding via tube
- •Other condition which contraindicates tube feeding
结局指标
主要结局
Time to feeding goal achievement
时间窗: up to 14 days
次要结局
- Percentage of nutrition goal met(daily up to 21 days)
- Gastrointestinal measures assessment(up to 21 days)
- Serum biochemical markers assessment(baseline and completion of study)
- Assessment of frequency and nature of adverse events(daily up to 21 days)
研究者
研究点 (1)
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