Nutrition Strategies and Malnutrition Assessment Management Systems for Preventing Malnutrition in Children With Solid Tumors: an Exploratory Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Weight for age Z score
研究概览
简要总结
The purpose of this study is to establish a standardized nutrition intervention procedure for children with solid tumors, and to explore the effectiveness and clinical applicability of standardized nutrition management and short peptide-based enteral nutrition intervention for improving the nutritional status of children with malignant solid tumors.
After admission, patients in the intervention group will receive standardized nutrition management provided by a nutrition support team composed of dietitians, nutritionists, clinicians, and nursing teams. Basic information, including diet, enteral and parenteral nutrition, nutritional status and clinical data, will be collected during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female, age 0-18 years old
- •Pathological diagnosis is malignant solid tumor with untreated initial onset
排除标准
- 未提供
研究组 & 干预措施
Standardized nutrition management（+ short peptide ONS) Group
The children in this group will be given standardized nutrition management after admission. They will follow the five-step treatment principle of malnutrition. Diet + nutrition education is the basic way, which is successively promoted to diet + oral nutrition supplement, enteral nutrition, partial enteral nutrition + supplementary parenteral nutrition, and total parenteral nutrition. When a nutritional treatment does not meet 60% of the target energy requirements for 3 to 5 days, the upper step of the treatment can be selected. For infants or newborns, when 75-80% of the target amount cannot be reached for 3-5 days, the upper step of the treatment can be selected.
During the study period, an additional 3 months of short peptide oral nutritional supplements (ONS) is expected to be performed in children enrolled from December 1, 2024 to February 28, 2025 to explore the improvement of the nutritional status of the children.
干预措施: Standardized nutritional management (Dietary Supplement)
Standardized nutrition management（+ short peptide ONS) Group
The children in this group will be given standardized nutrition management after admission. They will follow the five-step treatment principle of malnutrition. Diet + nutrition education is the basic way, which is successively promoted to diet + oral nutrition supplement, enteral nutrition, partial enteral nutrition + supplementary parenteral nutrition, and total parenteral nutrition. When a nutritional treatment does not meet 60% of the target energy requirements for 3 to 5 days, the upper step of the treatment can be selected. For infants or newborns, when 75-80% of the target amount cannot be reached for 3-5 days, the upper step of the treatment can be selected.
During the study period, an additional 3 months of short peptide oral nutritional supplements (ONS) is expected to be performed in children enrolled from December 1, 2024 to February 28, 2025 to explore the improvement of the nutritional status of the children.
干预措施: Standardized nutritional management + short peptide ONS (Dietary Supplement)
Control group
Clinical variables, biochemical markers, dietary data, and physical activity data will be collected at baseline and at each visit (admission to hospital, 1, 2, 3, 6, 12, 18, and 24 months after diagnosis).
结局指标
主要结局
Weight for age Z score
时间窗: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
Weight for age Z score = (Actual weight - reference population median) / reference population standard deviation
height/length for age Z score
时间窗: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
Height/length for age Z score = (Actual height/length - reference population median) / reference population standard deviation
BMI for age Z score
时间窗: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
BMI for age Z score = (Actual BMI - reference population median) / reference population standard deviation
次要结局
- dietary intake(1, 2, 3, 6, 12, 18, and 24 months after enrollment)
- serum albumin(1, 2, 3, 6, 12, 18, and 24 months after enrollment)
- serum prealbumin(1, 2, 3, 6, 12, 18, and 24 months after enrollment)
- hemoglobin(1, 2, 3, 6, 12, 18, and 24 months after enrollment)
- electrolytes(1, 2, 3, 6, 12, 18, and 24 months after enrollment)