Standardized Nutritional Management of Pediatric Patients With Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

Standardized 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.

Standardized 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

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

More Children's Hospital of Fudan University trials in China

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