DIStinguishing ChildrEn at Low Risk of Severe infectioN in Case of Febrile Neutropenia-7: Impact Study of a Clinical Decision Rule
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Change in quality of life score, calculated from the PedsQL™ scale between inclusion and Day 6.
研究概览
简要总结
Febrile neutropenia (NF) is the leading cause of unscheduled hospitalization in children with cancer. Management classically involves emergency admission to hospital for intravenous antibiotic treatment until resolution of fever and neutropenia. However, children with NF are a heterogeneous group with varying risks of severe infection (10-29%). This approach, which is recognized as excessive for low-risk episodes of severe infection, particularly in terms of quality of life and cost, is no longer recommended. Management should move to a more personalized model that takes into account the individual probability of severe infection. Clinical decision rules (CDRs) have been proposed to facilitate risk stratification, but none are useful in our French population because of insufficient reproducibility or effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Followed for hemopathy or cancer,
- •Presenting with post-chemotherapy NF,
- •With social security coverage,
- •With parents able to provide appropriate home supervision,
- •Consent of parents and child if able to give consent.
排除标准
- •NF to diagnosis of tumor disease,
- •Child with palliative care,
- •Child who has had an allogeneic hematopoietic stem cell transplant within the past year,
- •NF immediately following an autologous hematopoietic stem cell transplant,
- •Participation in the study during a previous NF,
- •Curative antibiotic therapy or documented infection prior to admission,
- •Initial management at a non-investigative center,
- •Refusal of the child or parents to participate
- •Translated with www.DeepL.com/Translator (free version)
结局指标
主要结局
Change in quality of life score, calculated from the PedsQL™ scale between inclusion and Day 6.
时间窗: at day 6
The Pediatric Quality of Life Inventory (PedsQL) is a brief measure of health-related quality of life in children and young people. The measure can be completed by parents (the Proxy Report) as well as children and young people (the Self-Report). On the PedsQL Generic Core Scales, for ease of interpretability, items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life). To reverse score, transform the 0-4 scale items to 0-100 as follows: 0=100, 1=75, 2=50, 3=25, 4=0.
次要结局
未报告次要终点