Severity of RSV Infections in Twins

Bronchiolitis Clinical Trial

— TwinSeVeRS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05070975
• Other study ID #: 69HCL21_0634
• Status: Completed
• Start date: November 5, 2021
• Est. completion date: January 27, 2022

Study information

• Verified date: July 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: January 27, 2022
• Est. primary completion date: January 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 354 Days

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis
• Communicable Diseases
• Infections
• Respiratory Syncytial Virus Infections
• RSV Infection

Intervention

Other:
• Epidemiology
Assessment of the discrepancy of clinical severity of RSV-infections between twin infants.

Locations

Country	Name	City	State
France	Hôpital Femme-Mère-Enfant des Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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