CHU de Martinique
Fort-de-France, 97261, Martinique
NCT Number: NCT04415229
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.
Looking for future studies?
Notify Me0 year–2 year
All sexes
Observational
Fort-de-France, 97261, Martinique
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
Research hypotheses The investigators believe that the seasonality and characteristics of RSV bronchiolitis are indeed specific to tropical areas such as Martinique.
The investigators hypothesize that, in tropical areas, certain favourable climatic conditions, prevailing in the month prior to the usual period of RSV bronchiolitis outbreak onset or during the epidemic, would be intrinsically linked to the characteristics of these epidemics.
Indeed, RSV is a virus that particularly likes humid atmospheres in which to develop. These conditions are conducive during the rainy season in the tropics (second half of the year in Martinique), which could explain a different seasonality from that known in temperate regions (where the epidemic occurs rather during the winter). These favourable climatic conditions can be approximated by measuring the humidity level, the number of rainy days, the average temperature, the rate of sunshine and cloud cover and the average wind strength. In addition, respiratory irritants such as sand mist or other air pollution, as assessed by the air quality index, could be among the parameters that explain these differences.
The investigators propose to retrospectively analyze 12 years of hospital data on RSV bronchiolitis cases in Martinique among hospitalized children 2 years of age and younger, the main targets of RSV, and therefore the population most vulnerable to this virus. The investigators will focus only on hospitalized patients because they are the most severely affected patients, which will allow us to accurately describe the clinical severity criteria in this at-risk population.
Main objective Describe the temporal distribution of RSV bronchiolitis cases in children 2 years of age or younger hospitalized in Martinique, over a 12-year period (2007 to 2018), based on climatic parameters prevailing in the month before the beginning of the epidemic or during the epidemic.
Secondary objectives
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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 : 7-day average humidity (%)
Time frame: 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 : number of significant rainy days (j)
Time frame: Through study completion, an average of 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 : average temperature (°C) over one day
Time frame: 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 : global solar radiation (joules/cm²)
Time frame: 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 : average wind force (km/h)
Time frame: 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))
Time frame: Through study completion, an average of 1 year
Climatic parameters: 7-day average humidity (%)
Time frame: 1 year
Climatic parameters: number of significant rainy days (j)
Time frame: 1 year
Climatic parameters: average temperature (°C) over one day
Time frame: 1 year
Climatic parameters: solar radiation (joules/cm²)
Time frame: 1 year
Climatic parameters: average wind force (km/h)
Time frame: 1 year
Climatic parameters: concentrations, in µg/m3, of air pollutants such as nitrogen oxides (NOx) and fine particulate matter (PM10).
Time frame: 1 year
Weekly and monthly distribution of RSV bronchiolitis
Time frame: By week
Weekly distribution of RSV bronchiolitis
Time frame: Through study completion, an average of 1 year
Monthly distribution of RSV bronchiolitis
Time frame: 1 year
Characteristics of each epidemic (beginning, peak and end of epidemic; number of incident cases per week, month and year; incidence curve per week, month and year; rate of attainment (cumulative incidence of infection over the period))
Time frame: 1 year
Characteristics of incident cases: sex, age, hospitalization in pediatric ICU, oxygen therapy, assisted respiration rate, enteral nutrition rate, prematurity, chronic respiratory pathology of the former prematurity, congenital heart disease.)
Time frame: 1 year
Correlation between the climatic parameters studied and the occurrence of RSV bronchiolitis
University Hospital Center of Martinique
Other
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
Acronym: VRS-12
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04959734
Bronchial Diseases, Bronchiolitis
Leicester, United Kingdom
View Trial DetailsNCT01006629
Bronchopulmonary Dysplasia, Cardiovascular Abnormalities
Ivanovo, Russia
View Trial DetailsNCT07411261
Asthma, Asthma Childhood
Amiens, France
View Trial DetailsNCT05987800
Bronchopulmonary Dysplasia, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Jette, Brussels Capital, Belgium
View Trial Details