Clinical trial NCT06730204: Standardized Nutritional Management of Pediatric Patients With Solid Tumors
Official title: Nutrition Strategies and Malnutrition Assessment Management Systems for Preventing Malnutrition in Children With Solid Tumors: an Exploratory Intervention Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tumor, Solid
Children
Nutritional Intervention
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 400
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 1. Male and female, age 0-18 years old
2. Pathological diagnosis is malignant solid tumor with untreated initial onset

Primary outcomes:
measure: Weight for age Z score
timeFrame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
measure: height/length for age Z score
timeFrame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
measure: BMI for age Z score
timeFrame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
Secondary outcomes:
measure: dietary intake
timeFrame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
measure: serum albumin
timeFrame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
measure: serum prealbumin
timeFrame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
measure: hemoglobin
timeFrame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
measure: electrolytes
timeFrame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
Other outcomes:
measure: fecal intestinal flora
timeFrame: 3 months after enrollment
measure: Endotoxin
timeFrame: 3 months after enrollment
measure: Diamine oxidase
timeFrame: 3 months after enrollment
measure: D-lactic acid
timeFrame: 3 months after enrollment
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
References:
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