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Predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants (PRSVH)

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ClinicalTrials.gov Identifier: NCT04144816
Recruitment Status : Not yet recruiting
First Posted : October 30, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

The VRS (Respiratory Syncytial Virus) study group in Lyon is a working that aims to understand, predict and prevent the burden of disease caused by human respiratory syncytial virus (RSV) infection in infants. Incidence of RSV-associated hospitalization in the first year of life was estimated at 14.5 (95% CI 13.4-15.6) per 1000 births in a cohort study in Lyon, France. Related direct medical annual costs were estimated for this cohort at 364,269€, mostly attributed to children born during the RSV season (231,959€) and children born premature (108,673€). This study will combine existing hospital specimens and databases to determine the respective role of socio demographic factors, clinical risk factors, level of cord specific antibody at birth, and virus characteristic in the Respiratory Syncytial Virus (RSV) Hospitalization outcome in Infants.

Regarding the introduction of a new RSV vaccine and RSV-specific neutralizing antibodies, these data are of prime importance to guide future vaccine policies.


Condition or disease Intervention/treatment
Syncytial Virus Respiratory Infection RSV Infection Respiratory Syncytial Virus Infections RSV Bronchiolitis Other: Not applicable (no intervention)

Detailed Description:

Objective:

To determine the main predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants

Study design:

Prospective epidemiological, observational, one-center cohort study with sample collection.

Study population:

Birth cohort of infants born in Lyon before and during the RSV circulation period (October to march) with a follow-up until one year old (from birth until the age of 1 year maximum):

  • Estimate Birth cohort (n=5,000).
  • Estimate number of RSVH case (n=110).
  • Estimate number of Blood cordon associated with a RSVH (Respiratory Syncytial Virus Human) case (n=60)

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exploring the Role of Socio Demographic, Clinical Risk Factors, Cord Specific Antibody at Birth, and Virus Characteristic, in Respiratory Syncytial Virus (RSV) in Hospitalized vs Ambulant Infants
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : October 2020

Group/Cohort Intervention/treatment
Passive Birth Cohort

This will be a multicenter, prospective, observational cohort study conducted across the Lyon Public hospital maternity (HFME : Hospital for women, mother and children, Croix-Rousse, Lyon-Sud) recruited from the general population.

Infants born between October 2019 and march 2020. At birth the remains (after diagnosis use) of cord blood samples will be store. Groups of RSVh cases and control will be class at one year of age using the hospital data (RSV must be confirmed by RT-PCR). Parents will be informed of the protocol. If enrolled available hospital data will be use and RSV serology testing perform on the store blood cordon.

Other: Not applicable (no intervention)
Not applicable (no intervention)




Primary Outcome Measures :
  1. Number of cases included in the cohort with RT-PCR (Retrotranscription) confirmed RSV hospitalization occurring from birth until the age of 1 year [ Time Frame: 1 year after inclusion ]
    Cases were defined as a new admission to one of the conventional pediatric hospital departments with a RSV positive sample during the hospital stay the first 3 years of life.

  2. Number of cases included in the cohort with RT-PCR confirmed RSV hospitalization occurring from birth until the age of 3 years. [ Time Frame: 3 years after inclusion ]
    Cases were defined as a new admission to one of the conventional pediatric hospital departments with a RSV positive sample during the hospital stay the first 3 years of life.


Secondary Outcome Measures :
  1. Quantitative level of anti-RSV IgG measure [ Time Frame: 3 years after inclusion ]
    The quantitative level of anti-RSV IgG at birth in blood cord cordon will be compare between the cases group and the control group (No admission to one of the conventional pediatric hospital departments with a RSV positive sample during the hospital stay the first 3 years of life)

  2. Quantitative level of anti-RSV IgG (Immunoglobulin G) measure [ Time Frame: 3 years after inclusion ]
    The quantitative level of anti-RSV IgG at birth in blood cord cordon will be compare between the cases group and the control group (No admission to one of the conventional pediatric hospital departments with a RSV positive sample during the hospital stay the first 3 years of life)


Biospecimen Retention:   Samples Without DNA
Blood Cordon (remained after diagnosis use) Respiratory samples (remained after diagnosis use)


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Birth cohort of 5 000 infants of the general population recruited from the HCL (Public hospital of Lyon) maternity wards during the first days after birth
Criteria

Inclusion Criteria:

  • Children born alive at participating centers.
  • Parents living in the Rhone Alpes Auvergne region

Exclusion Criteria:

  • Parents non-willing to participate
  • Parents living outside the region

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04144816


Contacts
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Contact: Jean-Sebastien CASALEGNO, MD/PhD 4 72 07 10 23 ext +33 jean-sebastien.casalegno@chu-lyon.fr

Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04144816    
Other Study ID Numbers: PRSVH_2019
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Syncytial Virus Infections
Bronchiolitis
Virus Diseases
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections