NCT04415229

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,237

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2021

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

1.7 years

First QC Date

April 9, 2020

Last Update Submit

July 18, 2023

Conditions

Bronchiolitis; Respiratory Syncytial Virus

Keywords

BronchiolitisRespiratory Syncytial VirusChildInfant, prematureBronchopulmonary DysplasiaHeart Defects, CongenitalTropical climateHumidityEpidemiologyAir pollution

Outcome Measures

Primary Outcomes (12)

  • Incident cases of RSV bronchiolitis in children between 2007 and 2018

    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 (%)

    1 year

  • Incident cases of RSV bronchiolitis in children between 2007 and 2018

    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)

    1 year

  • Incident cases of RSV bronchiolitis in children between 2007 and 2018

    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

    Through study completion, an average of 1 year

  • Incident cases of RSV bronchiolitis in children between 2007 and 2018

    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)

    1 year

  • Incident cases of RSV bronchiolitis in children between 2007 and 2018

    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)

    1 year

  • Incident cases of RSV bronchiolitis in children between 2007 and 2018

    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))

    1 year

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

    Climatic parameters: 7-day average humidity (%)

    Through study completion, an average of 1 year

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

    Climatic parameters: number of significant rainy days (j)

    1 year

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

    Climatic parameters: average temperature (°C) over one day

    1 year

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

    Climatic parameters: solar radiation (joules/cm²)

    1 year

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

    Climatic parameters: average wind force (km/h)

    1 year

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

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

    1 year

Secondary Outcomes (6)

  • Distribution of RSV bronchiolitis

    1 year

  • Distribution of RSV bronchiolitis

    By week

  • Distribution of RSV bronchiolitis

    Through study completion, an average of 1 year

  • Characteristics of each epidemic

    1 year

  • Characteristics of incident cases

    1 year

  • +1 more secondary outcomes

Eligibility Criteria

Age0 Years - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

children 2 years of age or younger hospitalized in Martinique with RSV bronchiolitis cases, over a 12-year period (2007 to 2018)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Martinique

Fort-de-France, 97261, Martinique

Location

Related Publications (9)

  • 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: 27480325BACKGROUND

  • RAMEIX-WELTI M, GAULT E. Le virus respiratoire syncytial (VRS): état actuel des connaissances. Feuill. Biol. 2017;29-41.

    BACKGROUND

  • 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: 17357048BACKGROUND

  • 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: 27864751BACKGROUND

  • 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: 28070870BACKGROUND

  • 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: 23175761BACKGROUND

  • 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: 21177891BACKGROUND

  • 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: 20399493BACKGROUND

  • Equipe de surveillance de la bronchiolite. Surveillance de la bronchiolite en France, saison 2016-2017. Bull Epidémiol Hebd. 2017;650-657.

    RESULT

MeSH Terms

Conditions

BronchiolitisPremature BirthBronchopulmonary DysplasiaHeart Defects, Congenital

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVentilator-Induced Lung InjuryLung InjuryInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital Abnormalities

Study Officials

  • Olivier FLECHELLES, MD

    Hospital University of Martinique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

June 4, 2020

Study Start

October 2, 2019

Primary Completion

June 2, 2021

Study Completion

April 12, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations

MA(1)