Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 28
- 主要终点
- BMI z-score
研究概览
简要总结
The purpose of this study is to test whether the provision of ONS to malnourished children across Europe, in addition to standard counselling, will improve weight gain and other outcomes.
The hypothesis to be tested is:
• Supplementation with ONS in malnourished paediatric patients will lead to increased WFH gain, as well as less malnutrition related complications (e.g. infections).
Primary outcome • The change in BMI z-score over the intervention period of 3 months
Secondary outcomes
• The change in WFH-weight for height (z-scores) over the intervention period of 3 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 24 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children treated at the participating paediatric centres during the study period (inpatients or outpatients)
- •Age between 24 months to 12 years at inclusion
- •WFH at inclusion <- 1,5 SD - >-2,5 SD (based on WHO) OR Decrease in WFH z-score of ≥1 SD within the last 3 months, and underlying disease with high risk of undernutrition
- •Children who would be considered candidates for oral nutrition intervention (but do not need tube feeding)
- •Written informed consent of parents/caregivers
排除标准
- •Children in need of intensive care
- •Inability to consume ONS (e.g. major gastrointestinal dysfunction)
- •Children, for whom normal nutrition intervention would be inappropriate (e.g. food intolerance, allergy)
- •Use of parenteral feeding and/or enteral tube-feeding
- •Severe edema (>0.5 cm pitting edema on the dorsum of the foot)
- •Participation in another intervention study involving investigational or marketed products concomitantly or within two weeks prior to entry into the trial.
- •Children having received enteral nutrition treatment for underweight in the previous month
- •Oncology patients during chemo-, radio-therapy
- •Expected hospital stay at inclusion longer than 7 days
研究组 & 干预措施
Oral Nutritional Supplement (ONS)
Diet consultation for the child/family + ONS
干预措施: The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml (Dietary Supplement)
No Oran Nutritional Supplement (ONS)
Diet consultation for the child/family
结局指标
主要结局
BMI z-score
时间窗: 3 months
The change in BMI z-score over the intervention period of 3 months
次要结局
- Gastrointestinal complications(3 months)
- Weight change(3 months)
- Infectious complications(3 months)
- Hospital admissions(3 months)
研究者
Dr. Michael Chourdakis
Lecturer of Medical Nutrition
Aristotle University Of Thessaloniki