Standardized Nutritional Management of Pediatric Patients With Solid Tumors

Not Applicable

Recruiting

• Conditions: Tumor, Solid; Children; Nutritional Intervention

• Registration Number: NCT06730204
• Lead Sponsor: Children's Hospital of Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2024-11-05
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China