Evaluation of the Advantage in the Use of Enteral Nutrition in Children Treated for Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Z-score
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Z-score
时间窗: 6 months
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
次要结局
- BMI(6 months)
- complications(1 year)
- albumin(6 months)
研究者
DEUTSCH Hélène
Dr Hélène DEUTSCH
Central Hospital, Nancy, France