NCT05070975

Brief Summary

Respiratory syncytial virus (RSV) infection is the most common cause of severe lower respiratory tract infection (LRTI) in the pediatric population worldwide. Age at the time of infection, prematurity, multiparity, exposure to smoke and the level of passive immunity transmitted at birth are the main risk factors for lower respiratory infection associated with RSV. Other factors, including the innate immune response, respiratory microbiota, and intra-host viral heterogeneity, may also affect outcomes but are not fully considered in RSV infection. Exploring the impact of these factors is difficult due to the heterogeneity of the population which makes statistical adjustment difficult. Thus, twin models are useful in understanding the impact of the host on the environment, as twins often share similar exposure to infection and many risk factors, but not all are ie different prenatal and postnatal conditions, differential transfer of maternal antibodies and the genetic makeup of heterozygotes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 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

First Submitted

Initial submission to the registry

September 27, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 7, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

November 5, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2022

Completed
Last Updated

July 6, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

September 27, 2021

Last Update Submit

July 4, 2022

Conditions

Keywords

RSV infections in twinsBronchiolitisvery-severe-LRTIsevere-LRTILRTIupper respiratory tract infectionRSV infectionHumaninfant

Outcome Measures

Primary Outcomes (1)

  • Percentage of discordant twin pairs in severity of Respiratory Syncytial Virus infections.

    The primary outcome measure is the percentage of discordant twin pairs of at least one severity level on the WHO (World Health Organization) scale. The discrepancy in the level of severity is obtained by retrospective analysis of the data from the medical file.

    1 day

Study Arms (1)

Twins

Twins identified from the birth cohort (Hospices Civils de Lyon) with at least one twin hospitalized for an acute RSV-infection

Other: Epidemiology

Interventions

Assessment of the discrepancy of clinical severity of RSV-infections between twin infants.

Twins

Eligibility Criteria

AgeUp to 354 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Twins identified from the birth cohort (Hospices Civils de Lyon) with at least one twin hospitalized for an acute RSV-infection

You may qualify if:

  • Twins born at Hospices Civils de Lyon in the years 2012 to 2020
  • At least one twin hospitalized with positive RSV-PCR during the first year of life

You may not qualify if:

  • Major differential underlying disease between twins
  • Death of a twin before the RSV epidemic period of the first year of life
  • Nosocomial infection
  • Lack of understanding of the study or questionnaire by parents
  • Lack of parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Femme-Mère-Enfant des Hospices Civils de Lyon

Bron, 69677, France

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus InfectionsBronchiolitisRespiratory Tract Infections

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Design

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

Study Record Dates

First Submitted

September 27, 2021

First Posted

October 7, 2021

Study Start

November 5, 2021

Primary Completion

January 27, 2022

Study Completion

January 27, 2022

Last Updated

July 6, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations