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OpenTrials
Completed

NCT Number: NCT05070975

Severity of RSV Infections in Twins

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Epidemiology

Other

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

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: TwinSeVeRS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 7, 2021
Registry last updated
Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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