An observational study in Syncytial Virus Respiratory Infection, RSV Infection and Respiratory Syncytial Virus Infections, sponsored by Hospices Civils de Lyon. Status unknown. Open to participants aged 1 Day to 4 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-30.
Sponsored by Hospices Civils de Lyon · Observational
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.
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):
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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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
Exclusion Criteria:
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)
Number of cases included in the cohort with RT-PCR (Retrotranscription) confirmed RSV hospitalization occurring from birth until the age of 1 year
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.
Time frame: 1 year after inclusion
Number of cases included in the cohort with RT-PCR confirmed RSV hospitalization occurring from birth until the age of 3 years.
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.
Time frame: 3 years after inclusion
Quantitative level of anti-RSV IgG measure
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)
Time frame: 3 years after inclusion
Quantitative level of anti-RSV IgG (Immunoglobulin G) measure
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)
Time frame: 3 years after inclusion
No study locations are listed for this record.
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon