NCT06730204

Standardized Nutritional Management of Pediatric Patients With Solid Tumors

Nutrition Strategies and Malnutrition Assessment Management Systems for Preventing Malnutrition in Children With Solid Tumors: an Exploratory Intervention Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tumor, Solid
• Children
• Nutritional Intervention

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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

Timeline

• Start date: 2023-07-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-12-12
• Last updated: 2026-03-16

Locations

1 site across 1 country: China