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

niversity Medical Center Utrecht0 个研究点目标入组 2,500 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•- 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.

•- 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
•- 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:
•For the extension until 6 years of age:

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