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临床试验/NCT04415229
NCT04415229已完成不适用

Seasonality of Respiratory Syncytial Virus (RSV) Bronchiolitis in Children Aged 2 Years or Less Hospitalized in Martinique (French West Indies) a Tropical Area From 2007 to 2018

University Hospital Center of Martinique1 个研究点 分布在 1 个国家目标入组 1,237 人开始时间: 2019年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,237
试验地点
1
主要终点
Incident cases of RSV bronchiolitis in children between 2007 and 2018

研究概览

简要总结

The epidemiological characteristics of RSV bronchiolitis differ between tropical and temperate zones. This study seeks to understand which climatic factors could influence the specific seasonality of these bronchiolitis in Martinique and to verify the hypothesis put forward: influence of favorable climatic conditions in the month preceding the start of the epidemic. In addition, the study will improve our knowledge of the epidemiology of the infection in order to improve the management of infants.

详细描述

Respiratory Syncytial Virus (RSV) infections are the leading cause of hospitalization for respiratory distress in infants (50% of children under 1 year of age are infected with the virus, 100% of children under 3 years of age). They are responsible for 66,000 to 199,000 deaths in children under 5 years of age worldwide, and 15,000 to 20,000 hospitalizations in France depending on the year. It is a highly contagious virus whose transmission is both respiratory and by hand and which appreciates humidity to develop.

In temperate regions where this infection has been well studied, it occurs preferentially during the winter, probably favoured by the cold and humidity, as well as by the confinement of individuals during this season. The more the child is young, premature, has a chronic respiratory pathology or congenital heart disease, the more sever the disease. Prevention is based on the injection of a monoclonal antibody (Palivizumab) before the start of the epidemic season and on conventional hygiene measures. But today, little epidemiological data is available for tropical regions and in Martinique, which makes it impossible to understand why, how and when RSV develops on our island. Some epidemiological studies carried out in tropical regions point to the possibility that the humidity in the air would favour viral development and in fact, these epidemics are more frequently found during the rainy season. The humidity level, the number of rainy days, the rate of sunshine and cloud cover, and finally the importance of the wind, could explain a different seasonality from that known in temperate regions (seasonality being linked to the virus circulation patterns and being defined as the ability to re-emerge at the same period from one year to the next).

Research issues A first study carried out at the University hospital of Martinique over a period of 2 years (from July 1, 2007 to December 31, 2008) has made it possible to specify the epidemiology a little better but the results need to be confirmed. This work seems to show that the epidemic starts earlier than in temperate zones: (late August - early September to late November - early December) versus (November - December to March - April) respectively. The number of cases per epidemic can change significantly (factor 2.5). However, this first study was not long enough to ensure that the seasonality identified will be systematically repeated from one year to the next. Moreover, this study did not allow us to specify the number of children with clinical severity criteria on our island.

By carrying out a study over a longer period, the investigators will have a better understanding of seasonality and the rate of disease in children in Martinique, allowing us to better anticipate the extent and severity of these phenomena. This precision will allow us to determine when to start Monoclonal Antibody injections for vulnerable children (essentially infants with chronic respiratory pathologies or congenital cardiac pathologies, i.e. approximately 30 children per year in Martinique). The investigators will also be able to anticipate future needs of beds and caregivers to the epidemic to come or in progress. The investigators will therefore have better preventive care for children at risk and better preparation of the healthcare offer.

Research questions

研究设计

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

入排标准

年龄范围
0 Years 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • two years of age or younger
  • hospitalized for bronchiolitis in the pediatrics department of the University hospital of Martinique over the period 2007 to 2018
  • with a confirmed virological diagnosis of RSV virus by ImmunoFluorescence (IF) from 01/01/2007 to 31/01/2016 and from 01/02/2016 by Reverse transcription polymerase chain reaction.
  • with a clinical diagnosis of bronchiolitis (presentation of suggestive clinical signs such as cough, respiratory distress associated with a febrile illness, with rhinopharyngitis in the previous days)
  • no opposition from the legal representative for the use of the data from the medical file in the context of the research. This non-opposition is documented in the patient's medical file

排除标准

  • opposition from the legal representative for the use of the data from the medical file
  • Inability to inform legal representatives of the conduct of the research

结局指标

主要结局

Incident cases of RSV bronchiolitis in children between 2007 and 2018

时间窗: 1 year

Monthly distribution of incident cases of RSV bronchiolitis in children aged 2 years or less hospitalized from 2007 to 2018 (number of cases/month) according to the values of the following climatic parameters recorded during the month preceding the beginning of the epidemic or during the epidemic : concentrations, in µg/m3, of air pollutants (such as nitrogen oxides (NOx) and fine particulate matter (PM10))

RSV cases by month compare with climatic factors at the same time

时间窗: 1 year

Climatic parameters: concentrations, in µg/m3, of air pollutants such as nitrogen oxides (NOx) and fine particulate matter (PM10).

次要结局

  • Characteristics of incident cases(1 year)
  • Distribution of RSV bronchiolitis(Through study completion, an average of 1 year)
  • Characteristics of each epidemic(1 year)
  • Climatic parameters and RSV bronchiolitis(1 year)

研究者

发起方
University Hospital Center of Martinique
申办方类型
Other
责任方
Sponsor

研究点 (1)

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