跳至主要内容
临床试验/NCT06112132
NCT06112132招募中不适用

National Observatory of Children Hospitalized for Bronchiolitis

Association Clinique Thérapeutique Infantile du val de Marne1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2023年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,500
试验地点
1
主要终点
Number of patients hospitalized for bronchiolitis

研究概览

简要总结

This study is an observational, multicenter and prospective study for surveillance of case of hospitalised children for bronchiolitis associated or not to RSV or other viruses (isolated or associated with RSV)

详细描述

The aim of this surveillance is to observe and describe the cases hospitalized for bronchiolitis in the 2023/2024 season in the context of routine immunization with Nirsevimab.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
1 Day 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children under 12 months of age
  • In one of the 6 study sites
  • From October 15, 2023
  • For acute bronchiolitis defined according to current national and international recommendations
  • Hospitalized from the pediatric emergency department.

排除标准

  • Refusal to participate by patient relative or legal representative

结局指标

主要结局

Number of patients hospitalized for bronchiolitis

时间窗: 1 year

Assessment of the number of hospitalized bronchiolitis in the context of routine immunization with Nirsevimab

次要结局

  • Proportion of RSV vs non-RSV associated to bronchiolitis hospitalizations(1 year)
  • Length of hospital stay of children with bronchiolitis in France according to immunization status with Nirsevimab(1 year)
  • Proportion of other viruses associated to bronchiolitis hospitalizations.(1 year)
  • Proportion of patients immunized with Nirsevimab among children hospitalized for bronchiolitis(1 year)
  • Proportion of demographics and clinical characteristics of patients hospitalized for bronchiolitis overall(1 year)
  • Proportion of demographics, clinical and viral characteristics of patients hospitalized for bronchiolitis requiring ventilation support(1 year)
  • Length of hospital stay of children with bronchiolitis overall in France(1 year)

研究者

发起方
Association Clinique Thérapeutique Infantile du val de Marne
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

National Observatory of Children Hospitalized for... | 临床试验