NCT05838495已完成不适用
A Single-center, Open-label Study on the Nutritional Adequacy, Tolerability, and Safety of a Hypercaloric, Plant-based, Real Food Ingredient Formula for Tube Fed Pediatric Patients
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2023年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Nutritional efficacy - energy
研究概览
简要总结
To assess the efficacy, tolerance, and safety of a pediatric enteral formula in children.
详细描述
The purpose of this study is to assess the efficacy (ability to meet prescribed calorie and protein needs), tolerance, and safety of a pediatric enteral formula (i.e., the study product) in participants aged 1-13 years for 14 days of use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Medically stable, enterally tube-fed children
- •Aged 1 to 13 years (inclusive) at the time of screening.
- •Currently tolerating enteral feeding and should be appropriate for study formula
- •Requires enteral tube feeding to provide 90% or more of their nutritional needs
- •signed informed consent
排除标准
- •Has a condition which contraindicates enteral feeding (e.g., intestinal obstruction).
- •Currently using or has previously used the study product
- •Any medical condition or contraindicated medications that would contraindicate use of the study product
- •Any illness within ~5-7 days of screening and/or baseline lasting >48 hours and assessed by the PI to have affected nutritional intake on a case-by-case basis.
- •Participation in another interventional clinical study
- •Any condition or abnormality that, in the opinion of the PI, would compromise the safety of the participant or the quality of the study data.
结局指标
主要结局
Nutritional efficacy - energy
时间窗: 14 days
Percent of daily calorie nutritional goals met
次要结局
- Nutritional efficacy - protein(14 days)
- Bristol Stool Chart(14 days)
- Adverse events(14 days)
- Frequency of nausea(14 days)
- Frequency of vomiting(14 days)
研究者
研究点 (2)
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