Trials / Unknown
UnknownNCT04144816
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 5,000 (estimated)
- Sponsor
- Hospices Civils de Lyon · Academic / Other
- Sex
- All
- Age
- 1 Day – 4 Days
- Healthy volunteers
- Accepted
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)
Conditions
- Syncytial Virus Respiratory Infection
- RSV Infection
- Respiratory Syncytial Virus Infections
- RSV Bronchiolitis
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Not applicable (no intervention) | Not applicable (no intervention) |
Timeline
- Start date
- 2019-10-01
- Primary completion
- 2020-03-01
- Completion
- 2020-10-01
- First posted
- 2019-10-30
- Last updated
- 2019-10-30
Source: ClinicalTrials.gov record NCT04144816. Inclusion in this directory is not an endorsement.