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BackgroundRespiratory syncytial virus (RSV) causes significant morbidity and mortality in infants worldwide. Although prematurity and cardiopulmonary disease are risk factors for severe disease, the majority of infants hospitalized with RSV are previously healthy. Various vaccines and therapeutics are under development and expected to be available in the near future. To inform the use of these new vaccines and therapeutics, it is necessary to determine the burden of RSV disease in Europe. We will prospectively follow-up a birth cohort to obtain incidence data on RSV acute respiratory tract infection (ARTI).MethodsMulticenter prospective study of a birth cohort consisting of 10 000 healthy infants, recruited during 3 consecutive years. RSV associated hospitalization in the first year of life will be determined by questionnaires and hospital chart reviews. A nested cohort of 1000 infants will be actively followed. In case of ARTI, a respiratory sample will be collected for RSV molecular diagnosis.ResultsThe primary outcome is the incidence rate of RSV-associated hospitalization in the first year of life. In the active cohort the primary outcome is RSV associated ARTI and MA-ARTI.ConclusionsWe will provide key information to fill the gaps in knowledge about the burden of RSV disease in healthy infants.Clinical trials registrationNCT03627572.

Original publication

DOI

10.1093/infdis/jiaa310

Type

Journal article

Journal

The Journal of infectious diseases

Publication Date

10/2020

Volume

222

Pages

S606 - S612

Addresses

Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital/University Medical Center Utrecht, Utrecht, The Netherlands.

Keywords

RESCEU Investigators, Humans, Respiratory Syncytial Virus, Human, Respiratory Tract Infections, Respiratory Syncytial Virus Infections, Respiratory Syncytial Virus Vaccines, Hospitalization, Incidence, Risk Factors, Cohort Studies, Prospective Studies, Infant, Europe, Biomarkers