Children, Nutritional Intervention, Tumor, Solid
Conditions
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.
Interventions
DIETARY_SUPPLEMENTStandardized nutritional management
The children 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.
DIETARY_SUPPLEMENTStandardized nutritional management + short peptide ONS
During the study period, an additional 3 months of short peptide ONS enteral nutrition intervention is expected to be performed in children enrolled from Dec 1, 2024 to Feb 28, 2025 to explore the improvement of the nutritional status of the children. Short peptide type ONS 30ml/(kg.d) will be taken orally for children under 3 years old, and 20ml/(kg.d) for children over 3 years old. Due to conditional restrictions, standardized nutritional management + short peptide ONS intervention is only carried out in this subgroup. Inclusion criteria for short peptide ONS enteral nutrition intervention: 1. Male and female, age 1-10 years old 2. Pathological diagnosis is malignant solid tumor with untreated initial onset 3. It is expected to receive enteral nutrition intervention for 3 months 4. Clear consciousness, willing to cooperate, no serious dysfunction of major organ functions
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female, age 0-18 years old 2. Pathological diagnosis is malignant solid tumor with untreated initial onset
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight for age Z score | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| dietary intake | 1, 2, 3, 6, 12, 18, and 24 months after enrollment | Unit: kcal/d A 24-hour dietary survey record will be conducted on the children to evaluate the quantity, type and energy of the food consumed. |
| serum albumin | 1, 2, 3, 6, 12, 18, and 24 months after enrollment | Unit: g/L This indicator is measured by the biochemical assembly line Remisol in the hospital laboratory department. |
| serum prealbumin | 1, 2, 3, 6, 12, 18, and 24 months after enrollment | Unit: mg/L This indicator is measured by the biochemical assembly line Remisol in the hospital laboratory department. |
| hemoglobin | 1, 2, 3, 6, 12, 18, and 24 months after enrollment | Unit: g/L This indicator is measured by the hemocytometer XS800I in the hospital laboratory department. |
| electrolytes | 1, 2, 3, 6, 12, 18, and 24 months after enrollment | Unit: mmol/L This indicator is measured by the biochemical assembly line Remisol in the hospital laboratory department. |
Countries
China
Contacts
CONTACTTian Qian, PhD
Outcome results
None listed