INSPIRE CHILD: Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cytokines
研究概览
简要总结
The INSPIRE CHILD-study is a clinical research project focused on understanding lung diseases in children. The study aims to explore how the presence of certain bacteria, immune responses, and inflammatory markers in the lungs are connected to different lung diseases in pediatric patients.
Background:
Lung diseases in children can have long-lasting effects on their health, not only during childhood but also as they grow into adults. However, the specific causes and mechanisms behind these diseases are not yet fully understood. The INSPIRE CHILD-study is designed to investigate whether children with various lung conditions have distinct differences in the types of bacteria, immune system activity, and inflammation in their lungs.
Hypothesis:
Different lung diseases in children are hypothesized to be associated with unique patterns of bacteria, immune responses, and inflammation in the lungs By studying these patterns, the investigators hope to gain new insights that could lead to better diagnostic tools and more personalized treatments for children suffering from lung diseases.
Children already scheduled to undergo bronchoscopy are included in the study. A small sample of fluid from the lungs is collected, and the sample is analyzed for bacteria, immune markers, and signs of inflammation. This research could pave the way for improved care and treatment for young patients with lung conditions.
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
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranging from new-born to 17 years of age.
- •Diagnosed with or being assessed for a lung disease.
- •Possible to sample at least 2 ml of BAL-fluid besides the scheduled amount during the bronchoscopy.
排除标准
- •Age older than 17 years.
- •Not undergoing diagnosis at Childrens Center for Pulmonary and Allergic diseases.
- •Failure to meet the requirement of being able to sample an additional 2 ml of BAL-fluid.
结局指标
主要结局
Cytokines
时间窗: Day 0 (Subsequent to study inclusion)
Legendplex assay for measuring cytokines in bronchoalveolar lavage fluid and plasma (e.g. IL-1-beta, IL-1RA, IL-2, IL-6, IL-8, IL-10, IL-17, IL-18, IL-33, IL-35, TGF-beta, TNF-alpha)
Immunophenotype
时间窗: Day 0 (Subsequent to study inclusion)
Using flow cytometry to investigate immune cells: e.g. Neutrophils, Eosinophils, Monocytes, NK-cells, B-cells, CD4+-T-cells, CD8+-T-cells
Lung microbiome
时间窗: Day 0 (Subsequent to study inclusion)
We seek to investigate whether it is feasible to map the microbiome, virome and mycobiome of the pediatric lung from BAL-fluid. The study will investigate and report findings of bioinformatics analysis.
次要结局
- Concentration range for selected interleukins in BAL-fluid(Day 0 (Subsequent to study inclusion))
- Lung disease association(Through study completion, an average of 2 year)
- Clinical symptoms(2 weeks prior to enrollment)
研究者
Sune Rubak
Consultant, Associate Professor
Aarhus University Hospital