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临床试验/NCT05070975
NCT05070975已完成不适用

Phenotype Severity of RSV-infections in Twins During the First Year of Life

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2021年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
1
主要终点
Percentage of discordant twin pairs in severity of Respiratory Syncytial Virus infections.

研究概览

简要总结

Respiratory syncytial virus (RSV) infection is the most common cause of severe lower respiratory tract infection (LRTI) in the pediatric population worldwide. Age at the time of infection, prematurity, multiparity, exposure to smoke and the level of passive immunity transmitted at birth are the main risk factors for lower respiratory infection associated with RSV. Other factors, including the innate immune response, respiratory microbiota, and intra-host viral heterogeneity, may also affect outcomes but are not fully considered in RSV infection. Exploring the impact of these factors is difficult due to the heterogeneity of the population which makes statistical adjustment difficult. Thus, twin models are useful in understanding the impact of the host on the environment, as twins often share similar exposure to infection and many risk factors, but not all are ie different prenatal and postnatal conditions, differential transfer of maternal antibodies and the genetic makeup of heterozygotes.

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
— 至 354 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Twins born at Hospices Civils de Lyon in the years 2012 to 2020
  • At least one twin hospitalized with positive RSV-PCR during the first year of life

排除标准

  • Major differential underlying disease between twins
  • Death of a twin before the RSV epidemic period of the first year of life
  • Nosocomial infection
  • Lack of understanding of the study or questionnaire by parents
  • Lack of parental consent

结局指标

主要结局

Percentage of discordant twin pairs in severity of Respiratory Syncytial Virus infections.

时间窗: 1 day

The primary outcome measure is the percentage of discordant twin pairs of at least one severity level on the WHO (World Health Organization) scale. The discrepancy in the level of severity is obtained by retrospective analysis of the data from the medical file.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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