Severity of RSV Infections in Twins
TwinSeVeRS
Phenotype Severity of RSV-infections in Twins During the First Year of Life
1 other identifier
observational
94
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2021
Shorter than P25 for all trials
1 active site
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
September 27, 2021
CompletedFirst Posted
Study publicly available on registry
October 7, 2021
CompletedStudy Start
First participant enrolled
November 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2022
CompletedJuly 6, 2022
July 1, 2022
3 months
September 27, 2021
July 4, 2022
Conditions
Keywords
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
Interventions
Assessment of the discrepancy of clinical severity of RSV-infections between twin infants.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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