Predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants

NCT ID: NCT04144816

Last Updated: 2019-10-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2020-10-31

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)

Conditions

Syncytial Virus Respiratory Infection; RSV Infection; Respiratory Syncytial Virus Infections; RSV Bronchiolitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Passive Birth Cohort

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.

Not applicable (no intervention)

Intervention Type: OTHER

Not applicable (no intervention)

Interventions

Not applicable (no intervention)

Not applicable (no intervention)

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 4 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jean-Sebastien CASALEGNO, MD/PhD

Role: CONTACT

jean-sebastien.casalegno@chu-lyon.fr

4 72 07 10 23 ext. +33

Other Identifiers

PRSVH_2019

Identifier Type: -

Identifier Source: org_study_id