Clinical trial NCT04144816: Predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Syncytial Virus Respiratory Infection
RSV Infection
Respiratory Syncytial Virus Infections
RSV Bronchiolitis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 5000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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)

Eligibility 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

Primary outcomes:
measure: Number of cases included in the cohort with RT-PCR (Retrotranscription) confirmed RSV hospitalization occurring from birth until the age of 1 year
timeFrame: 1 year after inclusion
measure: Number of cases included in the cohort with RT-PCR confirmed RSV hospitalization occurring from birth until the age of 3 years.
timeFrame: 3 years after inclusion
Secondary outcomes:
measure: Quantitative level of anti-RSV IgG measure
timeFrame: 3 years after inclusion
measure: Quantitative level of anti-RSV IgG (Immunoglobulin G) measure
timeFrame: 3 years after inclusion
Other outcomes:
Locations:
Study officials:
References: