AI Article Synopsis

  • Respiratory syncytial virus (RSV) significantly impacts healthy infants, leading to many hospitalizations worldwide, and understanding its burden in Europe is critical for future vaccine and treatment development.
  • A study will follow 10,000 healthy infants over three years to track RSV-related hospitalizations through questionnaires and medical records, focusing on a smaller group of 1,000 for detailed respiratory sampling.
  • The main goal is to gather data on the rate of RSV-related hospitalizations and respiratory infections in infants, which will enhance knowledge on RSV's impact and aid healthcare strategies.

Article Abstract

Background: Respiratory 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).

Methods: Multicenter 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.

Results: The 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.

Conclusions: We will provide key information to fill the gaps in knowledge about the burden of RSV disease in healthy infants.

Clinical Trials Registration: NCT03627572.

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Source
http://dx.doi.org/10.1093/infdis/jiaa310DOI Listing

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