Predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants

• Conditions: Respiratory Syncytial Virus Infections; RSV Bronchiolitis; Syncytial Virus Respiratory Infection; RSV Infection
• Interventions: Other: Not applicable (no intervention)

• Registration Number: NCT04144816
• Lead Sponsor: Hospices Civils de Lyon

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)

Study Timeline

• Status Verified: 2019-10
• Study Start: 2019-10
• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2019-10-29
• Last Update Submitted: 2019-10-29
• Study First Posted: 2019-10-30
• Last Update Posted: 2019-10-30
• Primary Completion: 2020-03
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Children born alive at participating centers.
• Parents living in the Rhone Alpes Auvergne region

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Exclusion Criteria

• Parents non-willing to participate
• Parents living outside the region

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Passive Birth Cohort	Not applicable (no intervention)	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.

Primary Outcome Measures

Name	Time	Method
Number of cases included in the cohort with RT-PCR (Retrotranscription) confirmed RSV hospitalization occurring from birth until the age of 1 year	1 year after inclusion	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.
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 inclusion	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.

Secondary Outcome Measures

Name	Time	Method
Quantitative level of anti-RSV IgG measure	3 years after inclusion	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)
Quantitative level of anti-RSV IgG (Immunoglobulin G) measure	3 years after inclusion	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)