TwinSeVeRS: Severity of RSV Infections in Twins

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT05070975

Collaborator

(none)

Enrollment

Location

2.7

Actual Duration (Months)

34.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
RSV Infection Bronchiolitis	Other: Epidemiology

Study Design

Study Type:

Observational

Actual Enrollment :

94 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Phenotype Severity of RSV-infections in Twins During the First Year of Life

Actual Study Start Date :

Nov 5, 2021

Actual Primary Completion Date :

Jan 27, 2022

Actual Study Completion Date :

Jan 27, 2022

Arms and Interventions

Arm	Intervention/Treatment
Twins Twins identified from the birth cohort (Hospices Civils de Lyon) with at least one twin hospitalized for an acute RSV-infection	Other: Epidemiology Assessment of the discrepancy of clinical severity of RSV-infections between twin infants.

Arm

Intervention/Treatment

Twins

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

Other: Epidemiology

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

Outcome Measures

Primary Outcome Measures

Percentage of discordant twin pairs in severity of Respiratory Syncytial Virus infections. [1 day]
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.