NCT04944160

Brief Summary

The magnitude of seasonal Respiratory Syncytial Virus (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" (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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
Last Updated

May 2, 2022

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

June 28, 2021

Last Update Submit

April 26, 2022

Conditions

Keywords

bronchiolitisAsthmaPneumonia

Outcome Measures

Primary Outcomes (1)

  • Reduction of the number of children hospitalized for a RSV-infection during pre and post-Covid-19 pandemic RSV-winter-epidemic.

    2019-2020-winter-epidemic and 2020-2021-winter-epidemic are assessed during June and July, 2021.

Study Arms (2)

Pre Covid-19 cohort

Children hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a reverse transcriptase - polymerase chain reaction (RT-PCR) positive for Respiratory Syncytial Virus (RSV) during the 2019-2020 winter epidemic

Other: Medical records analysisOther: Comparison of cohorts

Post Covid-19 cohort

Children hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a reverse transcriptase - polymerase chain reaction (RT-PCR) positive for Respiratory Syncytial Virus (RSV) during the 2020-2021 winter epidemic

Other: Medical records analysisOther: Comparison of cohorts

Interventions

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

Post Covid-19 cohortPre Covid-19 cohort

To compare pre and post Covid-19 epidemics in terms of numbers of admissions, and proportion of severe disease.

Also known as: Epidemiology
Post Covid-19 cohortPre Covid-19 cohort

Eligibility Criteria

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

Child hospitalized at " Hôpital Femme Mère Enfant ", Lyon, France with viral respiratory infection.

You may qualify if:

  • Child hospitalized at " Hôpital Femme Mère Enfant ", Lyon, France
  • Polymerase Chain Reaction (PCR) positive at Respiratory Syncytial Virus (RSV)

You may not qualify if:

  • Parent's refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupement Hospitalier EST - Hospices Civils de Lyon

Bron, 69500, France

Location

Related Publications (1)

  • Casalegno JS, Ploin D, Cantais A, Masson E, Bard E, Valette M, Fanget R, Targe SC, Myar-Dury AF, Doret-Dion M, Massoud M, Queromes G, Vanhems P, Claris O, Butin M, Pillet S, Ader F, Bin S, Gaymard A, Lina B, Morfin F; VRS study group in Lyon; Javouhey E, Gillet Y. Characteristics of the delayed respiratory syncytial virus epidemic, 2020/2021, Rhone Loire, France. Euro Surveill. 2021 Jul;26(29):2100630. doi: 10.2807/1560-7917.ES.2021.26.29.2100630.

MeSH Terms

Conditions

Respiratory Syncytial Virus InfectionsBronchiolitisAsthmaPneumonia

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsBronchitisRespiratory Tract InfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

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

Study Record Dates

First Submitted

June 28, 2021

First Posted

June 29, 2021

Study Start

March 15, 2021

Primary Completion

May 15, 2021

Study Completion

June 28, 2021

Last Updated

May 2, 2022

Record last verified: 2021-06

Locations