Respiratory Syncytial Virus Infections Clinical Trial
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
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):
- 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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