REspiratory Syncytial virus Consortium in EUrope (RESCEU) study: Defining the burden of disease of Respiratory Syncytial Virus in Europe.

Recruiting

Conditions: COVID-19
RSV-bronchiolitis
RSV-infection
SARS-CoV-2
10047438
10024970

Registration Number: NL-OMON52977

Lead Sponsor: niversity Medical Center Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 2500

Inclusion Criteria

- Healthy children, gestation age at least 37+0, born at participating centers.
- Written informed consent obtained from parents.
- Parents ability and willingness to adhere to protocol-specified procedures
(active cohort).

Inclusion criteria for COVID-19 related part
- Household member of participating children in the active birth cohort study
(including participating children themselves)
- Written informed consent obtained from parents.
- Parents ability and willingness to adhere to protocol-specified procedures

Inclusion criteria for the extension until 6 years of age
- Participated in the RESCEU birth cohort study in the active cohort or,
participated in the RESCEU birth cohort study in the passive cohort and were
hospitalized because of an ARTI.
- Informed consent obtained from parents.

Exclusion Criteria

- History of clinically significant medical illness including but not limited
to, cardiovascular, respiratory, renal, gastrointestinal, haematologic,
neurological, endocrine, immunological, 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 (Clinically significant) Congenital heart disease
o Down*s syndrome
- Gestational age of less than 37+0 weeks.
- Acute severe medical condition at moment of heel prick (e.g. sepsis, severe
asphyxia, for which the child is admitted to the hospital). (Exclusioncriterium
only applicable in the active cohort)
- Child in care (with foster parents or at home under supervision of social
services).
- Parents not able to understand and communicate in the local language.
- Living outside catchment area of study sites.
- Mother vaccinated against RSV during pregnancy

For the COVID-19 related part:
- None

For the extension until 6 years of age:
- None

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- The primary outcome is to determine the incidence of RSV infection-associated<br /><br>ARTI, RSV associated medically attended ARTI (MA-ARTI) (active cohort) and<br /><br>RSV-related hospitalization (all) during the first year of life.</p><br>

Secondary Outcome Measures