Evaluation of the Advantage in the Use of Enteral Nutrition in Children Treated for Acute Lymphoblastic Leukemia
1 other identifier
observational
300
1 country
1
Brief Summary
This is a multicenter retrospective study (Reims and Nancy), with data collection over 12 years from 01/01/2010 to 12/31/2022 Patients included are children diagnosed with acute lymphoblastic leukemia between 2010 and 2021 in the 2 centers. Patients will be categorized into 3 groups:
- No nutritional support
- Support by enteral nutrition
- Parenteral nutrition support Their nutritional status will be assessed at the end of induction, at 6 months and then at 12 months from diagnosis. The main objective of this study is therefore to compare the nutritional status of children with acute lymphoblastic leukemia depending on whether they received enteral or parenteral nutritional support during their treatment. The secondary objective is to evaluate the occurrence of complications during treatment according to the nutritional support received.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2023
CompletedFirst Submitted
Initial submission to the registry
October 26, 2023
CompletedFirst Posted
Study publicly available on registry
October 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedOctober 31, 2023
October 1, 2023
1.5 years
October 26, 2023
October 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Z-score
Compare the improvement in Z-score between the date of diagnosis and 6 months from diagnosis in children using parenteral nutrition and those using enteral nutrition during treatment of their acute lymphoblastic leukemia
6 months
Secondary Outcomes (3)
BMI
6 months
albumin
6 months
complications
1 year
Study Arms (2)
enteral nutrition
children who received enteral nutritional support during treatment
parenteral nutrition
children who received parenteral nutritional support during treatment
Interventions
Parents will be classified based on whether they received enteral or parenteral nutritional support during treatment.
Eligibility Criteria
children diagnosed with acute lymphoblastic leukemia between 2010 and 2021 in Nancy and Reims
You may qualify if:
- Children between 1 and 18 years old diagnosed with Medium risk/ High Risk B acute lymphoblastic leukemia or Standard/ High Risk T acute lymphoblastic leukemia between 2010 and 2021 in Nancy and Reims.
You may not qualify if:
- Patients less than 1 year old
- leukémia with philadelphia chromosome
- standard risk B acute lymphoblastic leukemia
- bone marrow transplant during treatment
- death during the year following diagnosis
- refusal of the patient (parents) to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU Nancy
Vandœuvre-lès-Nancy, 54500, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Hélène DEUTSCH
Study Record Dates
First Submitted
October 26, 2023
First Posted
October 31, 2023
Study Start
October 1, 2023
Primary Completion
April 1, 2025
Study Completion
May 1, 2025
Last Updated
October 31, 2023
Record last verified: 2023-10