1. Respiratory Syncytial Virus Consortium in Europe (RESCEU) Birth Cohort Study: Defining the Burden of Infant Respiratory Syncytial Virus Disease in Europe
- Author
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Wildenbeest, Joanne G, Zuurbier, Roy P, Korsten, Koos, van Houten, Marlies A, Billard, Marie N, Derksen-Lazet, Nicole, Snape, Matthew D, Drysdale, Simon B, Robinson, Hannah, Pollard, Andrew J, Heikkinen, Terho, Cunningham, Steve, Leach, Amanda, Martinón-Torres, Federico, Rodríguez-Tenreiro Sánchez, Carmen, Gómez-Carballa, Alberto, Bont, Louis J, Wildenbeest, Joanne, Zuurbier, Roy, van Houten, Marlies, Billard, Marie, Bont, Louis, Drysdale, Simon, Snape, Matthew, Pollard, Andrew, Sánchez, Carmen Rodríguez-Tenreiro, Nair, Harish, Campbell, Harry, Openshaw, Peter, Beutels, Philippe, Molero, Eva, Meijer, Adam, Sanders, Elisabeth, Fischer, Thea Kølsen, van den Berge, Maarten, Giaquinto, Carlo, Esser, Mark, Knirsch, Charles, Gallichan, Scott, Aerssens, Jeroen, and Rosen, Brian
- Subjects
Pediatrics ,medicine.medical_specialty ,viruses ,Respiratory Syncytial Virus Infections ,Disease ,Virus ,Cohort Studies ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,030225 pediatrics ,Respiratory Syncytial Virus Vaccines ,Humans ,Immunology and Allergy ,Medicine ,Prospective Studies ,030212 general & internal medicine ,Respiratory system ,Prospective cohort study ,Respiratory Tract Infections ,Acute respiratory tract infection ,Cardiopulmonary disease ,business.industry ,Incidence ,Infant ,3. Good health ,Europe ,Hospitalization ,Clinical trial ,Infectious Diseases ,Respiratory Syncytial Virus, Human ,Cohort ,business ,Biomarkers - Abstract
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.
- Published
- 2020
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