NCT05348655

Brief Summary

The magnitude of seasonal RSV epidemics brings each year new logistical challenges for the hospitalization of young infants with bronchiolitis that overwhelm hospital capacities and lead to specific winter plans with deprogramming and mobilization of human and logistical resources. The Covid-19 pandemic has changed the way winter epidemics are presented. For example, the seasonal RSV epidemic was shifted by several months in Lyon, with an impression of a lower incidence of hospitalized cases, with a population of older children and with fewer signs of clinical severity. This is largely attributable to the widespread use of barrier gestures and social distancing measures, known as "non-pharmacological interventions" or NPI. Given the magnitude of the reduction of the RSV epidemic, it is legitimate to analyze the benefits of NPIs to draw lessons for maintaining preventive measures around RSV-vulnerable populations; moreover, new preventive pharmacological interventions are soon to be marketed, whether they are particularly refined and long half-life anti-RSV monoclonal antibodies, RSV vaccines for mothers or for newborns and infants. In this perspective, it is crucial to properly define the populations at risk of severe disease to establish a legitimate hierarchy in the implementation of different preventive strategies. The study of the RSV epidemic is a high potential model because of the convergence of epidemiological, virological, and pharmacological knowledge. However, the study of the impact of the pandemic on the epidemiology of rhinovirus also seems promising because, for reasons unknown to date, it seems that the pandemic did not have the same reducing impact on the rhinovirus epidemic; in the latter case, the interest is to confirm the resistance of this virus and to look for more fundamental explanations, for example, on viral interactions. On a previous study (see NTC 04944160), 519 infants were recruited in the Pre-Covid-19 season population, and 277 infants were recruited in the first Per-Covid-19 season population.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

3.1 years

First QC Date

April 26, 2022

Last Update Submit

April 26, 2022

Conditions

Keywords

RSV epidemicCovid-19-RSV interactionNon-pharmacological-interventionsBronchiolitisAsthmaPneumonia

Outcome Measures

Primary Outcomes (1)

  • Annual evolution of the number and severity of RSV-infection in hospitalized children during per-Covid-19 epidemic compared to pre-Covid-19 pandemic.

    Description of number of cases for each clinical picture according to pre-SARS-CoV-2 pandemic and per-SARS-CoV-2 pandemic year.

    Day 0

Study Arms (2)

Pre Covid-19 cohort

Children hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a RT-PCR positive for RSV during the 2019-2020 winter epidemic

Other: epidemiology

Per Covid-19 cohort

Children hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a RT-PCR positive for RSV during the 2020-2021, 2021-2022, 2022-2023, and 2023-2024 epidemic. The need for continuation of the study will be reassessed after each season

Other: epidemiology

Interventions

To review of medical records to describe diagnosis and severity of the disease

Also known as: Medical records analysis
Per Covid-19 cohortPre Covid-19 cohort

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a RT-PCR positive for RSV

You may qualify if:

  • Child hospitalized at " Hôpital Femme Mère Enfant ", Lyon, France
  • Positive RSV-PCR

You may not qualify if:

  • Parent's refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Virology Lab

Lyon, 69004, France

Location

Pediatric Departement

Lyon, 69500, France

Location

MeSH Terms

Conditions

BronchiolitisAsthmaPneumonia

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Jean-Sébastien CASALEGNO, MCU-PH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2022

First Posted

April 27, 2022

Study Start

June 1, 2022

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

April 27, 2022

Record last verified: 2022-04

Locations