COVID-19 RSV-bronchiolitis RSV-infection SARS-CoV-2
Conditions
Interventions
None listed
Sponsors
University Medical Center Utrecht
Eligibility
Age
No minimum to 64 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - The primary outcome is to determine the incidence of RSV infection-associated ARTI, RSV associated medically attended ARTI (MA-ARTI) (active cohort) and RSV-related hospitalization (all) during the first year of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary outcome measures are: - To estimate how RSV infection of different severity relates to wheeze up to age 3 years. The incidence and severity of wheeze will be determined by annual questionnaires at age 1 year, 2 years and 3 years (active cohort and all children hospitalized for RSV ARTI) - To determine the rate of all-cause medically attended (inpatient or outpatient) ARTI. - To determine mortality (RSV associated and all-cause) through all RSV seasons of follow up - To determine health care costs, health care resource use, interruption of normal activities, and Health Related Quality of Life (HRQoL) in RSV-associated and all-cause medically attended (inpatient or outpatient) ARTI patients and their families. - To determine the incidence of RSV-related secondary bacterial respiratory tract infections within 21 days after onset of RSV infection and their association with antibiotic use in hospitalized RSV ARTI patients (all children) and non-hospitalized RSV ARTI patients (active cohort). - To collect clinical samples for biomarker analysis from a subset of infants in the active cohort. - To determine the incidence rate of other respiratory pathogens (influenza, rhinovirus, etc.) associated with all medically attended (inpatient or outpatient) ARTI. - To determine the proportion of viral ARTI attributable to RSV. - To determine important risk factors for RSV infection (by severity and healthcare utilization) COVID-19 related part: - The incidence of overall, asymptomatic, mild and medically attended SARS-CoV-2 infection in children and their parents. - Transmission patterns of SARS-CoV-2 within households with young children - Risk of transmission of asymptomatic SARS-CoV-2 infection to members of the same Household. - Description of symptom severity of SARS-CoV-2 in children. - Detection rate of SARS-CoV-2 in feces and saliva. CoKids Follow-up Study: - The incidence of different SARS-CoV-2 variants in children and their fam | — |
Countries
Netherlands
Outcome results
None listed