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Predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04144816
Acronym
PRSVH
Enrollment
5000
Registered
2019-10-30
Start date
2019-10-31
Completion date
2020-10-31
Last updated
2019-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus Infections, RSV Bronchiolitis, RSV Infection, Syncytial Virus Respiratory Infection

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)

Interventions

OTHERNot applicable (no intervention)

Not applicable (no intervention)

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 4 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of cases included in the cohort with RT-PCR (Retrotranscription) confirmed RSV hospitalization occurring from birth until the age of 1 year1 year after inclusionCases 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.
Number of cases included in the cohort with RT-PCR confirmed RSV hospitalization occurring from birth until the age of 3 years.3 years after inclusionCases 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

MeasureTime frameDescription
Quantitative level of anti-RSV IgG measure3 years after inclusionThe 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)
Quantitative level of anti-RSV IgG (Immunoglobulin G) measure3 years after inclusionThe 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)

Contacts

Primary ContactJean-Sebastien CASALEGNO, MD/PhD
jean-sebastien.casalegno@chu-lyon.fr4 72 07 10 23

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026