REspiratory Syncytial virus Consortium in EUrope (RESCEU): Presumed risk factors and biomarkers for RSV-related severe disease and related sequelae.

REspiratory Syncytial virus Consortium in EUrope (RESCEU): Presumed risk factors and biomarkers for RSV-related severe disease and related sequelae. - Understanding RSV: Severe disease and the long term consequences

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52425

Enrollment

160

Registered

2017-09-20

Start date

2017-11-06

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus RSV RS-virus

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: • Parent/carer of infant is willing and able to give informed consent for participation in the study. • Male or female, and less than 12 months of age at enrolment. • Parent has a telephone. • Hospitalized for

Exclusion criteria

Exclusion criteria: • History of concurrent clinically significant medical illness (not directly attributable to RSV infection) including but not limited to, cardiovascular, respiratory, renal, gastrointestinal, haematology, neurology, endocrinology, immunology, musculoskeletal, oncological or congenital disorders, as judged by the investigator* Specifically excluded examples include, but are not limited to: o Immunosuppressed states o Bronchopulmonary dysplasia/chronic lung disease of infancy o Congenital heart disease o Down*s syndrome • Prematurity, as defined as gestational age

Design outcomes

Primary

Measure	Time frame
The primary endpoint is disease severity of RSV infection in the first year of life.	—

Secondary

Measure	Time frame
1. Long term sequelae of RSV disease in the first year of life. 2. RSV viral load (copies/ml) and genetic sequence. 3. Differences in immune responses between mild and severe RSV infection. 4. Transcriptomics, proteomics, metabolomics and epigenetic signatures of mild and severe RSV infection. 5. Storage of biological samples (respiratory, saliva, blood, stool and urine) in a biobank. 6. Health care utilization and costs for RSV associated ARTI and long term sequelae. 7. Applicability of found biomarkers to infants with comorbidities with RSV infection. Extension to six years of age part: 8. To compare the incidence of asthma after RSV hospitalization with the incidence of asthma after milder RSV infection. 9. To compare the incidence of asthma after RSV hospitalization with the incidence of asthma after hospitalization due to other viral infections. 10. Determine the risk factors for persistent wheezing at the age of 3 and 6 years.	—

Measure

Time frame

1. Long term sequelae of RSV disease in the first year of life. 2. RSV viral load (copies/ml) and genetic sequence. 3. Differences in immune responses between mild and severe RSV infection. 4. Transcriptomics, proteomics, metabolomics and epigenetic signatures of mild and severe RSV infection. 5. Storage of biological samples (respiratory, saliva, blood, stool and urine) in a biobank. 6. Health care utilization and costs for RSV associated ARTI and long term sequelae. 7. Applicability of found biomarkers to infants with comorbidities with RSV infection. Extension to six years of age part: 8. To compare the incidence of asthma after RSV hospitalization with the incidence of asthma after milder RSV infection. 9. To compare the incidence of asthma after RSV hospitalization with the incidence of asthma after hospitalization due to other viral infections. 10. Determine the risk factors for persistent wheezing at the age of 3 and 6 years.

—

Countries

Netherlands

Outcome results