<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04415229</url>
  </required_header>
  <id_info>
    <org_study_id>19_MR004-11</org_study_id>
    <nct_id>NCT04415229</nct_id>
  </id_info>
  <brief_title>RSV Seasonality in Martinique in Children Aged 2 Years or Less</brief_title>
  <acronym>VRS-12</acronym>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Center of Martinique</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Center of Martinique</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The epidemiological characteristics of RSV bronchiolitis differ between tropical and&#xD;
      temperate zones. This study seeks to understand which climatic factors could influence the&#xD;
      specific seasonality of these bronchiolitis in Martinique and to verify the hypothesis put&#xD;
      forward: influence of favorable climatic conditions in the month preceding the start of the&#xD;
      epidemic. In addition, the study will improve our knowledge of the epidemiology of the&#xD;
      infection in order to improve the management of infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Respiratory Syncytial Virus (RSV) infections are the leading cause of hospitalization for&#xD;
      respiratory distress in infants (50% of children under 1 year of age are infected with the&#xD;
      virus, 100% of children under 3 years of age). They are responsible for 66,000 to 199,000&#xD;
      deaths in children under 5 years of age worldwide, and 15,000 to 20,000 hospitalizations in&#xD;
      France depending on the year. It is a highly contagious virus whose transmission is both&#xD;
      respiratory and by hand and which appreciates humidity to develop.&#xD;
&#xD;
      In temperate regions where this infection has been well studied, it occurs preferentially&#xD;
      during the winter, probably favoured by the cold and humidity, as well as by the confinement&#xD;
      of individuals during this season. The more the child is young, premature, has a chronic&#xD;
      respiratory pathology or congenital heart disease, the more sever the disease. Prevention is&#xD;
      based on the injection of a monoclonal antibody (Palivizumab) before the start of the&#xD;
      epidemic season and on conventional hygiene measures. But today, little epidemiological data&#xD;
      is available for tropical regions and in Martinique, which makes it impossible to understand&#xD;
      why, how and when RSV develops on our island. Some epidemiological studies carried out in&#xD;
      tropical regions point to the possibility that the humidity in the air would favour viral&#xD;
      development and in fact, these epidemics are more frequently found during the rainy season.&#xD;
      The humidity level, the number of rainy days, the rate of sunshine and cloud cover, and&#xD;
      finally the importance of the wind, could explain a different seasonality from that known in&#xD;
      temperate regions (seasonality being linked to the virus circulation patterns and being&#xD;
      defined as the ability to re-emerge at the same period from one year to the next).&#xD;
&#xD;
      Research issues A first study carried out at the University hospital of Martinique over a&#xD;
      period of 2 years (from July 1, 2007 to December 31, 2008) has made it possible to specify&#xD;
      the epidemiology a little better but the results need to be confirmed. This work seems to&#xD;
      show that the epidemic starts earlier than in temperate zones: (late August - early September&#xD;
      to late November - early December) versus (November - December to March - April)&#xD;
      respectively. The number of cases per epidemic can change significantly (factor 2.5).&#xD;
      However, this first study was not long enough to ensure that the seasonality identified will&#xD;
      be systematically repeated from one year to the next. Moreover, this study did not allow us&#xD;
      to specify the number of children with clinical severity criteria on our island.&#xD;
&#xD;
      By carrying out a study over a longer period, the investigators will have a better&#xD;
      understanding of seasonality and the rate of disease in children in Martinique, allowing us&#xD;
      to better anticipate the extent and severity of these phenomena. This precision will allow us&#xD;
      to determine when to start Monoclonal Antibody injections for vulnerable children&#xD;
      (essentially infants with chronic respiratory pathologies or congenital cardiac pathologies,&#xD;
      i.e. approximately 30 children per year in Martinique). The investigators will also be able&#xD;
      to anticipate future needs of beds and caregivers to the epidemic to come or in progress. The&#xD;
      investigators will therefore have better preventive care for children at risk and better&#xD;
      preparation of the healthcare offer.&#xD;
&#xD;
      Research questions&#xD;
&#xD;
        -  Descriptions of the characteristics of RSV bronchiolitis epidemics (seasonality, rate of&#xD;
           occurrence, case profile)?&#xD;
&#xD;
        -  What are the factors that may explain a specific seasonality and case rate in tropical&#xD;
           zones, especially Martinique? What is the role of climatic factors?&#xD;
&#xD;
      Research hypotheses The investigators believe that the seasonality and characteristics of RSV&#xD;
      bronchiolitis are indeed specific to tropical areas such as Martinique.&#xD;
&#xD;
      The investigators hypothesize that, in tropical areas, certain favourable climatic&#xD;
      conditions, prevailing in the month prior to the usual period of RSV bronchiolitis outbreak&#xD;
      onset or during the epidemic, would be intrinsically linked to the characteristics of these&#xD;
      epidemics.&#xD;
&#xD;
      Indeed, RSV is a virus that particularly likes humid atmospheres in which to develop. These&#xD;
      conditions are conducive during the rainy season in the tropics (second half of the year in&#xD;
      Martinique), which could explain a different seasonality from that known in temperate regions&#xD;
      (where the epidemic occurs rather during the winter). These favourable climatic conditions&#xD;
      can be approximated by measuring the humidity level, the number of rainy days, the average&#xD;
      temperature, the rate of sunshine and cloud cover and the average wind strength. In addition,&#xD;
      respiratory irritants such as sand mist or other air pollution, as assessed by the air&#xD;
      quality index, could be among the parameters that explain these differences.&#xD;
&#xD;
      The investigators propose to retrospectively analyze 12 years of hospital data on RSV&#xD;
      bronchiolitis cases in Martinique among hospitalized children 2 years of age and younger, the&#xD;
      main targets of RSV, and therefore the population most vulnerable to this virus. The&#xD;
      investigators will focus only on hospitalized patients because they are the most severely&#xD;
      affected patients, which will allow us to accurately describe the clinical severity criteria&#xD;
      in this at-risk population.&#xD;
&#xD;
      Main objective Describe the temporal distribution of RSV bronchiolitis cases in children 2&#xD;
      years of age or younger hospitalized in Martinique, over a 12-year period (2007 to 2018),&#xD;
      based on climatic parameters prevailing in the month before the beginning of the epidemic or&#xD;
      during the epidemic.&#xD;
&#xD;
      Secondary objectives&#xD;
&#xD;
        -  Describe the weekly and monthly distribution of RSV bronchiolitis, over the 12-year&#xD;
           study period, among children 2 years of age and younger hospitalized in Martinique.&#xD;
&#xD;
        -  Describe the characteristics of each epidemic observed over the study period.&#xD;
&#xD;
        -  Describe the characteristics of RSV bronchiolitis cases during the study period.&#xD;
&#xD;
        -  Analyze the association between the climatic parameters studied and the occurrence of&#xD;
           RSV bronchiolitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2019</start_date>
  <completion_date type="Actual">April 12, 2023</completion_date>
  <primary_completion_date type="Actual">June 2, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incident cases of RSV bronchiolitis in children between 2007 and 2018</measure>
    <time_frame>1 year</time_frame>
    <description>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 (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incident cases of RSV bronchiolitis in children between 2007 and 2018</measure>
    <time_frame>1 year</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incident cases of RSV bronchiolitis in children between 2007 and 2018</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incident cases of RSV bronchiolitis in children between 2007 and 2018</measure>
    <time_frame>1 year</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incident cases of RSV bronchiolitis in children between 2007 and 2018</measure>
    <time_frame>1 year</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incident cases of RSV bronchiolitis in children between 2007 and 2018</measure>
    <time_frame>1 year</time_frame>
    <description>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))</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RSV cases by month compare with climatic factors at the same time</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Climatic parameters: 7-day average humidity (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RSV cases by month compare with climatic factors at the same time</measure>
    <time_frame>1 year</time_frame>
    <description>Climatic parameters: number of significant rainy days (j)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RSV cases by month compare with climatic factors at the same time</measure>
    <time_frame>1 year</time_frame>
    <description>Climatic parameters: average temperature (°C) over one day</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RSV cases by month compare with climatic factors at the same time</measure>
    <time_frame>1 year</time_frame>
    <description>Climatic parameters: solar radiation (joules/cm²)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RSV cases by month compare with climatic factors at the same time</measure>
    <time_frame>1 year</time_frame>
    <description>Climatic parameters: average wind force (km/h)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RSV cases by month compare with climatic factors at the same time</measure>
    <time_frame>1 year</time_frame>
    <description>Climatic parameters: concentrations, in µg/m3, of air pollutants such as nitrogen oxides (NOx) and fine particulate matter (PM10).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distribution of RSV bronchiolitis</measure>
    <time_frame>1 year</time_frame>
    <description>Weekly and monthly distribution of RSV bronchiolitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of RSV bronchiolitis</measure>
    <time_frame>By week</time_frame>
    <description>Weekly distribution of RSV bronchiolitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of RSV bronchiolitis</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Monthly distribution of RSV bronchiolitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of each epidemic</measure>
    <time_frame>1 year</time_frame>
    <description>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))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of incident cases</measure>
    <time_frame>1 year</time_frame>
    <description>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.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Climatic parameters and RSV bronchiolitis</measure>
    <time_frame>1 year</time_frame>
    <description>Correlation between the climatic parameters studied and the occurrence of RSV bronchiolitis</description>
  </secondary_outcome>
  <enrollment type="Actual">1237</enrollment>
  <condition>Bronchiolitis; Respiratory Syncytial Virus</condition>
  <eligibility>
    <study_pop>
      <textblock>
        children 2 years of age or younger hospitalized in Martinique with RSV bronchiolitis cases,&#xD;
        over a 12-year period (2007 to 2018)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  two years of age or younger&#xD;
&#xD;
          -  hospitalized for bronchiolitis in the pediatrics department of the University hospital&#xD;
             of Martinique over the period 2007 to 2018&#xD;
&#xD;
          -  with a confirmed virological diagnosis of RSV virus by ImmunoFluorescence (IF) from&#xD;
             01/01/2007 to 31/01/2016 and from 01/02/2016 by Reverse transcription polymerase chain&#xD;
             reaction.&#xD;
&#xD;
          -  with a clinical diagnosis of bronchiolitis (presentation of suggestive clinical signs&#xD;
             such as cough, respiratory distress associated with a febrile illness, with&#xD;
             rhinopharyngitis in the previous days)&#xD;
&#xD;
          -  no opposition from the legal representative for the use of the data from the medical&#xD;
             file in the context of the research. This non-opposition is documented in the&#xD;
             patient's medical file&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  opposition from the legal representative for the use of the data from the medical file&#xD;
&#xD;
          -  Inability to inform legal representatives of the conduct of the research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olivier FLECHELLES, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital University of Martinique</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Martinique</name>
      <address>
        <city>Fort-de-France</city>
        <zip>97261</zip>
        <country>Martinique</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Martinique</country>
  </location_countries>
  <reference>
    <citation>Bont L, Checchia PA, Fauroux B, Figueras-Aloy J, Manzoni P, Paes B, Simoes EA, Carbonell-Estrany X. Defining the Epidemiology and Burden of Severe Respiratory Syncytial Virus Infection Among Infants and Children in Western Countries. Infect Dis Ther. 2016 Sep;5(3):271-98. doi: 10.1007/s40121-016-0123-0. Epub 2016 Aug 1.</citation>
    <PMID>27480325</PMID>
  </reference>
  <reference>
    <citation>RAMEIX-WELTI M, GAULT E. Le virus respiratoire syncytial (VRS): état actuel des connaissances. Feuill. Biol. 2017;29-41.</citation>
  </reference>
  <reference>
    <citation>Welliver TP, Garofalo RP, Hosakote Y, Hintz KH, Avendano L, Sanchez K, Velozo L, Jafri H, Chavez-Bueno S, Ogra PL, McKinney L, Reed JL, Welliver RC Sr. Severe human lower respiratory tract illness caused by respiratory syncytial virus and influenza virus is characterized by the absence of pulmonary cytotoxic lymphocyte responses. J Infect Dis. 2007 Apr 15;195(8):1126-36. doi: 10.1086/512615. Epub 2007 Mar 9.</citation>
    <PMID>17357048</PMID>
  </reference>
  <reference>
    <citation>Paes B, Fauroux B, Figueras-Aloy J, Bont L, Checchia PA, Simoes EA, Manzoni P, Carbonell-Estrany X. Defining the Risk and Associated Morbidity and Mortality of Severe Respiratory Syncytial Virus Infection Among Infants with Chronic Lung Disease. Infect Dis Ther. 2016 Dec;5(4):453-471. doi: 10.1007/s40121-016-0137-7. Epub 2016 Nov 18.</citation>
    <PMID>27864751</PMID>
  </reference>
  <reference>
    <citation>Checchia PA, Paes B, Bont L, Manzoni P, Simoes EA, Fauroux B, Figueras-Aloy J, Carbonell-Estrany X. Defining the Risk and Associated Morbidity and Mortality of Severe Respiratory Syncytial Virus Infection Among Infants with Congenital Heart Disease. Infect Dis Ther. 2017 Mar;6(1):37-56. doi: 10.1007/s40121-016-0142-x. Epub 2017 Jan 9.</citation>
    <PMID>28070870</PMID>
  </reference>
  <reference>
    <citation>Sande CJ, Mutunga MN, Medley GF, Cane PA, Nokes DJ. Group- and genotype-specific neutralizing antibody responses against respiratory syncytial virus in infants and young children with severe pneumonia. J Infect Dis. 2013 Feb 1;207(3):489-92. doi: 10.1093/infdis/jis700. Epub 2012 Nov 21.</citation>
    <PMID>23175761</PMID>
  </reference>
  <reference>
    <citation>Yamaguchi M, Sano Y, Dapat IC, Saito R, Suzuki Y, Kumaki A, Shobugawa Y, Dapat C, Uchiyama M, Suzuki H. High frequency of repeated infections due to emerging genotypes of human respiratory syncytial viruses among children during eight successive epidemic seasons in Japan. J Clin Microbiol. 2011 Mar;49(3):1034-40. doi: 10.1128/JCM.02132-10. Epub 2010 Dec 22.</citation>
    <PMID>21177891</PMID>
  </reference>
  <reference>
    <citation>Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simoes EA, Rudan I, Weber MW, Campbell H. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010 May 1;375(9725):1545-55. doi: 10.1016/S0140-6736(10)60206-1.</citation>
    <PMID>20399493</PMID>
  </reference>
  <results_reference>
    <citation>Equipe de surveillance de la bronchiolite. Surveillance de la bronchiolite en France, saison 2016-2017. Bull Epidémiol Hebd. 2017;650-657.</citation>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>April 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bronchiolitis</keyword>
  <keyword>Respiratory Syncytial Virus</keyword>
  <keyword>Child</keyword>
  <keyword>Infant, premature</keyword>
  <keyword>Bronchopulmonary Dysplasia</keyword>
  <keyword>Heart Defects, Congenital</keyword>
  <keyword>Tropical climate</keyword>
  <keyword>Humidity</keyword>
  <keyword>Epidemiology</keyword>
  <keyword>Air pollution</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04415229
org study id: 19_MR004-11
nct id: NCT04415229
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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

        -  Descriptions of the characteristics of RSV bronchiolitis epidemics (seasonality, rate of
           occurrence, case profile)?

        -  What are the factors that may explain a specific seasonality and case rate in tropical
           zones, especially Martinique? What is the role of climatic factors?

      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

        -  Describe the weekly and monthly distribution of RSV bronchiolitis, over the 12-year
           study period, among children 2 years of age and younger hospitalized in Martinique.

        -  Describe the characteristics of each epidemic observed over the study period.

        -  Describe the characteristics of RSV bronchiolitis cases during the study period.

        -  Analyze the association between the climatic parameters studied and the occurrence of
           RSV bronchiolitis.
observational model: Case-Only
time perspective: Retrospective
measure: Incident cases of RSV bronchiolitis in children between 2007 and 2018
time frame: 1 year
description: 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 (%)
measure: Incident cases of RSV bronchiolitis in children between 2007 and 2018
time frame: 1 year
description: 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)
measure: Incident cases of RSV bronchiolitis in children between 2007 and 2018
time frame: Through study completion, an average of 1 year
description: 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
measure: Incident cases of RSV bronchiolitis in children between 2007 and 2018
time frame: 1 year
description: 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)
measure: Incident cases of RSV bronchiolitis in children between 2007 and 2018
time frame: 1 year
description: 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)
measure: Incident cases of RSV bronchiolitis in children between 2007 and 2018
time frame: 1 year
description: 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))
measure: RSV cases by month compare with climatic factors at the same time
time frame: Through study completion, an average of 1 year
description: Climatic parameters: 7-day average humidity (%)
measure: RSV cases by month compare with climatic factors at the same time
time frame: 1 year
description: Climatic parameters: number of significant rainy days (j)
measure: RSV cases by month compare with climatic factors at the same time
time frame: 1 year
description: Climatic parameters: average temperature (°C) over one day
measure: RSV cases by month compare with climatic factors at the same time
time frame: 1 year
description: Climatic parameters: solar radiation (joules/cm²)
measure: RSV cases by month compare with climatic factors at the same time
time frame: 1 year
description: Climatic parameters: average wind force (km/h)
measure: RSV cases by month compare with climatic factors at the same time
time frame: 1 year
description: Climatic parameters: concentrations, in µg/m3, of air pollutants such as nitrogen oxides (NOx) and fine particulate matter (PM10).
measure: Distribution of RSV bronchiolitis
time frame: 1 year
description: Weekly and monthly distribution of RSV bronchiolitis
measure: Distribution of RSV bronchiolitis
time frame: By week
description: Weekly distribution of RSV bronchiolitis
measure: Distribution of RSV bronchiolitis
time frame: Through study completion, an average of 1 year
description: Monthly distribution of RSV bronchiolitis
measure: Characteristics of each epidemic
time frame: 1 year
description: 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))
measure: Characteristics of incident cases
time frame: 1 year
description: 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.)
measure: Climatic parameters and RSV bronchiolitis
time frame: 1 year
description: Correlation between the climatic parameters studied and the occurrence of RSV bronchiolitis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 0 Years
maximum age: 2 Years
healthy volunteers: No
last name: Olivier FLECHELLES, MD
role: Principal Investigator
affiliation: Hospital University of Martinique
facility: 
country: Martinique
citation: Bont L, Checchia PA, Fauroux B, Figueras-Aloy J, Manzoni P, Paes B, Simoes EA, Carbonell-Estrany X. Defining the Epidemiology and Burden of Severe Respiratory Syncytial Virus Infection Among Infants and Children in Western Countries. Infect Dis Ther. 2016 Sep;5(3):271-98. doi: 10.1007/s40121-016-0123-0. Epub 2016 Aug 1.
PMID: 27480325
citation: RAMEIX-WELTI M, GAULT E. Le virus respiratoire syncytial (VRS): état actuel des connaissances. Feuill. Biol. 2017;29-41.
citation: Welliver TP, Garofalo RP, Hosakote Y, Hintz KH, Avendano L, Sanchez K, Velozo L, Jafri H, Chavez-Bueno S, Ogra PL, McKinney L, Reed JL, Welliver RC Sr. Severe human lower respiratory tract illness caused by respiratory syncytial virus and influenza virus is characterized by the absence of pulmonary cytotoxic lymphocyte responses. J Infect Dis. 2007 Apr 15;195(8):1126-36. doi: 10.1086/512615. Epub 2007 Mar 9.
PMID: 17357048
citation: Paes B, Fauroux B, Figueras-Aloy J, Bont L, Checchia PA, Simoes EA, Manzoni P, Carbonell-Estrany X. Defining the Risk and Associated Morbidity and Mortality of Severe Respiratory Syncytial Virus Infection Among Infants with Chronic Lung Disease. Infect Dis Ther. 2016 Dec;5(4):453-471. doi: 10.1007/s40121-016-0137-7. Epub 2016 Nov 18.
PMID: 27864751
citation: Checchia PA, Paes B, Bont L, Manzoni P, Simoes EA, Fauroux B, Figueras-Aloy J, Carbonell-Estrany X. Defining the Risk and Associated Morbidity and Mortality of Severe Respiratory Syncytial Virus Infection Among Infants with Congenital Heart Disease. Infect Dis Ther. 2017 Mar;6(1):37-56. doi: 10.1007/s40121-016-0142-x. Epub 2017 Jan 9.
PMID: 28070870
citation: Sande CJ, Mutunga MN, Medley GF, Cane PA, Nokes DJ. Group- and genotype-specific neutralizing antibody responses against respiratory syncytial virus in infants and young children with severe pneumonia. J Infect Dis. 2013 Feb 1;207(3):489-92. doi: 10.1093/infdis/jis700. Epub 2012 Nov 21.
PMID: 23175761
citation: Yamaguchi M, Sano Y, Dapat IC, Saito R, Suzuki Y, Kumaki A, Shobugawa Y, Dapat C, Uchiyama M, Suzuki H. High frequency of repeated infections due to emerging genotypes of human respiratory syncytial viruses among children during eight successive epidemic seasons in Japan. J Clin Microbiol. 2011 Mar;49(3):1034-40. doi: 10.1128/JCM.02132-10. Epub 2010 Dec 22.
PMID: 21177891
citation: Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simoes EA, Rudan I, Weber MW, Campbell H. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010 May 1;375(9725):1545-55. doi: 10.1016/S0140-6736(10)60206-1.
PMID: 20399493
citation: Equipe de surveillance de la bronchiolite. Surveillance de la bronchiolite en France, saison 2016-2017. Bull Epidémiol Hebd. 2017;650-657.
responsible party type: Sponsor
mesh term: Bronchiolitis
sharing ipd: Undecided