RESCEU: Defining the Burden of RSV Disease

• Wheeze symptoms up to 3 years of age following RSV infection of different severity[ Time Frame: Year 1 - 3 ]
  Parent reported wheeze and doctor diagnosis of wheeze by routine care (for active birth cohort and children of passive birth cohort admitted for ARTI).
• Rate of all-cause medically attended (inpatient or outpatient) ARTI (active cohort).[ Time Frame: Year 1 ]
  Medically attended ARTI is defined as any medical care for a respiratory infection
• RSV associated and all-cause mortality through all RSV seasons of follow up (passive and active cohorts).[ Time Frame: Year 1 - 3 ]
  Mortality through all RSV seasons of follow up including RSV-associated deaths and all cause deaths.
• Health care costs and resource use[ Time Frame: Year 1 - 3 ]
  Health care utilisation for RSV-associated and all-cause medically attended (inpatient or outpatient) ARTI or respiratory events (active birth cohort).
• Incidence of RSV-related secondary bacterial RTIs within 21 days after onset of RSV infection and their association with antibiotic use in hospitalized RSV ARTI patients and non-hospitalized RSV ARTI patients.[ Time Frame: Within 21 days of RSV infection ]
  The incidence of RSV-associated secondary bacterial pneumonia and associated antibiotic consumption events within 21 days after onset of RSV-related symptoms.
• To collect clinical samples (blood, nasopharyngeal, stool and urine) for biomarker analysis (active cohort).[ Time Frame: Year 1 ]
  Biomarkers associated with RSV infection in infants
• Incidence rate of other respiratory pathogens (influenza, rhinovirus, human metapneumovirus, parainfluenzavirus, etc.) associated with all medically attended (inpatient or outpatient) ARTI (active cohort).[ Time Frame: Year 1 ]
  Additional viruses as detected by PCR testing on nasopharyngeal swab. Medically attended ARTI is defined as any medical care for a respiratory infection.
• Risk factors for RSV infection (by severity and healthcare utilisation) (active and passive cohort).[ Time Frame: Year 1 - 3 ]
  Demographic risks factors as outlined in CRF/demographic questionnaires
• The proportion of viral ARTI attributable to RSV (active cohort).[ Time Frame: Year 1 ]
  RSV and additional viruses as determined by PCR testing of nasopharyngeal swabs
• Health Related Quality of Life in RSV-associated and all-cause medically attended ARTI patients and their families (active cohort).[ Time Frame: Year 1-3 ]
  Annual questionnaire to families to determine interruption of normal activities associated with RSV and all-cause medically attended ARTI (active cohort).

This observational study will determine the burden of RSV disease in at least 2000 healthy infants over 3 years from September 2017 to September 2020. The study will determine the incidence of acute respiratory tract infection (ARTI) associated with RSV, of medically attended ARTI and RSV related hospitalisation. Mortality (RSV associated and all-cause) through all RSV seasons and the health care costs, resource use and Health Related Quality of Life will also be determined. The study also aims to determine important risk factors for RSV infection (by severity and healthcare utilisation.

• Procedure: venepuncture
  sample collection for analysis
• Procedure: nasopharyngeal swab
  sample collection for analysis

• : Active
  200 infants enrolled; family demographics collected and samples at day 5 (venepuncture, nasopharyngeal swab, urine and stool), actively followed up through their first RSV season for signs of respiratory symptoms. If respiratory symptoms are due to RSV infection (by point of care testing) samples as taken at day 5 are repeated at time of infection and again 7 weeks later. Annual questionnaire enquiring into respiratory illness, hospitalisations and family health and health quality of life, for up to 3 years.
• : Passive
  1800 infants enrolled; family demographics collected. Questionnaire follow up at 1 year of age enquiring into respiratory illness, hospitalisations and family health and health quality of life. If infant was hospitalised in first year of life, follow up will continue for up to 3 years.