Standardized Nutritional Management of Pediatric Patients With Solid Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorChildren's Hospital of Fudan University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Male and female, age 0-18 years old
Pathological diagnosis is malignant solid tumor with untreated initial onset
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Standardized nutritional management
Dietary supplementThe 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
Dietary supplementDuring 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
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Standardized nutrition management（+ short peptide ONS) GroupExperimental treatment 2 interventions
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Weight for age Z score
Weight for age Z score = (Actual weight - reference population median) / reference population standard deviation
Time frame
1, 2, 3, 6, 12, 18, and 24 months after enrollment2
height/length for age Z score
Height/length for age Z score = (Actual height/length - reference population median) / reference population standard deviation
Time frame
1, 2, 3, 6, 12, 18, and 24 months after enrollment3
BMI for age Z score
BMI for age Z score = (Actual BMI - reference population median) / reference population standard deviation
Time frame
1, 2, 3, 6, 12, 18, and 24 months after enrollmentSecondary outcomes
1
dietary intake
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.
Time frame
1, 2, 3, 6, 12, 18, and 24 months after enrollment2
serum albumin
Unit: g/L This indicator is measured by the biochemical assembly line Remisol in the hospital laboratory department.
Time frame
1, 2, 3, 6, 12, 18, and 24 months after enrollment3
serum prealbumin
Unit: mg/L This indicator is measured by the biochemical assembly line Remisol in the hospital laboratory department.
Time frame
1, 2, 3, 6, 12, 18, and 24 months after enrollment4
hemoglobin
Unit: g/L This indicator is measured by the hemocytometer XS800I in the hospital laboratory department.
Time frame
1, 2, 3, 6, 12, 18, and 24 months after enrollmentOther outcomes
1
fecal intestinal flora
For children with short peptide type enteral nutrition intervention, the above indicators will be collected at the time of enrollment and 3 months after enrollment.
Time frame
3 months after enrollment2
Endotoxin
For children with short peptide type enteral nutrition intervention, the above indicators will be collected at the time of enrollment and 3 months after enrollment.
Time frame
3 months after enrollment3
Diamine oxidase
For children with short peptide type enteral nutrition intervention, the above indicators will be collected at the time of enrollment and 3 months after enrollment.
Time frame
3 months after enrollment4
D-lactic acid
For children with short peptide type enteral nutrition intervention, the above indicators will be collected at the time of enrollment and 3 months after enrollment.
Time frame
3 months after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov