Dynamique Des Microbiomes Respiratoires Des Voies supérieures et inférieures associée à l'Asthme sévère Des Nourrissons
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- description of microbiomes from nasopharyngeal samples
研究概览
简要总结
Nature of potential dysbiosis, interrelation of the different microbiomes of the respiratory tract, and potential role of the immune system in the pathogenesis of severe asthma in infants, and its evolution under treatment.
Exploring and understanding these data is to improve patient care and discover new therapeutic targets.
The aim is to open up prospects for therapeutic studies, such as the use of azithromycin as an immunomodulator in infant asthma, the results of which are discordant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants less than 24 months old
- •Follow-up by a pneumo-pediatrician for severe asthma in infants
- •Requiring etiological investigations and assessment of severity in day hospitalization, including bronchial fibroscopy (HAS 2009)
- •Parent informed of the research and having signed consent
排除标准
- •Prematurity <32 WA
- •Congenital heart disease with significant left to right shunt
- •Chronic respiratory disease other than infant asthma (cystic fibrosis, bronchiolitis obliterans)
- •Antibiotic therapy in progress or administered the seven days preceding the date of inclusion (day hospitalization)
- •Refusal of bronchial fibroscopy
研究组 & 干预措施
All patients
All patients included will be followed for 1 year, every 3 months
干预措施: Blood sample (Other)
All patients
All patients included will be followed for 1 year, every 3 months
干预措施: Expectoration (Other)
All patients
All patients included will be followed for 1 year, every 3 months
干预措施: Nasopharyngeal swab (Other)
结局指标
主要结局
description of microbiomes from nasopharyngeal samples
时间窗: at 12 months
analysis of nasopharyngeal samples- NGS sequencing
Description of microbiomes from sputum samples
时间窗: at 12 months
analysis of sputum samples- NGS sequencing
description of microbiomes from bronchoalveolar fluids
时间窗: at 12 months
analysis of bronchoalveolar fluids- NGS sequencing
description of microbiomes from sputum samples
时间窗: at 9 months
analysis of sputum samples- NGS sequencing
description of microbiomes from bronchoalveolar fluids
时间窗: Inclusion
analysis of bronchoalveolar fluids - NGS sequencing
description of microbiomes from nasopharyngeal samples
时间窗: Inclusion
analysis of nasopharyngeal samples- NGS sequencing
description of microbiomes from sputum samples
时间窗: Inclusion
analysis of sputum samples- NGS sequencing
description of microbiomes from bronchoalveolar fluids
时间窗: at 3 months
analysis of bronchoalveolar fluids- NGS sequencing
description of microbiomes from nasopharyngeal samples
时间窗: at 3 months
analysis of nasopharyngeal samples- NGS sequencing
description of microbiomes from sputum samples
时间窗: at 3 months
analysis of sputum samples- NGS sequencing
description of microbiomes from bronchoalveolar fluids
时间窗: at 6 months
analysis of bronchoalveolar fluids- NGS sequencing
description of microbiomes from nasopharyngeal samples
时间窗: at 6 months
analysis of nasopharyngeal samples- NGS sequencing
description of microbiomes from sputum samples
时间窗: at 6 months
analysis of sputum samples- NGS sequencing
description of microbiomes from bronchoalveolar fluids
时间窗: at 9 months
analysis of bronchoalveolar fluids - NGS sequencing
description of microbiomes from nasopharyngeal samples
时间窗: at 9 months
analysis of nasopharyngeal samples- NGS sequencing
次要结局
未报告次要终点