Nutrition Strategies and Malnutrition Assessment Management Systems for Preventing Malnutrition in Children With Solid Tumors: an Exploratory Intervention Study
Overview
- Phase
- N/A
- Intervention
- Standardized nutritional management
- Conditions
- Tumor, Solid
- Sponsor
- Children's Hospital of Fudan University
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Weight for age Z score
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female, age 0-18 years old
- •Pathological diagnosis is malignant solid tumor with untreated initial onset
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Standardized nutritional management
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.
Intervention: Standardized nutritional management + short peptide ONS
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).
Outcomes
Primary Outcomes
Weight for age Z score
Time Frame: 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
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- 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)