This observational study will determine the burden of RSV disease in at least 2000 healthy infants over 6 years until November 2026. 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.
Infants will be recruited into one of two cohorts: Passive (around 1800 participants) - Demographic data will be collected at inclusion and a parental questionnaire at one year of age. Infants admitted to a hospital with an acute respiratory tract illness will be followed up to the age of 3 years or 6 years with additional consent. Active (around 200 participants) - Demographic data, parental questionnaire and the following samples will be collected at inclusion; blood, nasopharyngeal swabs, urine and stool. During the infants first RSV season (Oct - May) weekly phone contact will monitor respiratory symptoms. Infants with respiratory symptoms associated with RSV (confirmed by point of care testing) will have further samples of blood, nasopharyngeal swabs, urine and stool collected at the time of infection and 7 weeks later. Infants in the active cohort will be followed up for up to 3 years or 6 years with additional consent.
Study Type
OBSERVATIONAL
Enrollment
2,000
sample collection for analysis
sample collection for analysis
University of Oxford
Oxford, Oxfordshire, United Kingdom
Number of RSV associated Acute Respiratory Tract infections (ARTI) during the first year of life, to include the number of medically attended ARTI (MA-ARTI) and hospital admissions related to RSV.
RSV associated ARTI confirmed on nasopharyngeal swabs during home visits for all ARTI episodes during the RSV season, for testing using a RSV POC (Point of Care) test and reverse transcription-polymerase chain reaction (RT-PCR). Participants will be screened for hospital admission for respiratory symptoms by parental questionnaire at age 1 year. If positive, RSV will be confirmed by accessing hospital records. Medically attended RSV infection is defined as any medical care for RSV infection (defined as above)
Time frame: Year 1
The relationship between infant RSV infection of different severity and school age asthma
Symptoms of asthma, diagnosis and use of asthma medication will be measured by parental questionnaire/medical records.
Time frame: Year 4
The relationship between infant RSV infection of different severity and school age asthma
Symptoms of asthma, diagnosis and use of asthma medication will be measured by parental questionnaire/medical records.
Time frame: Year 5
The relationship between infant RSV infection of different severity and school age asthma
Symptoms of asthma, diagnosis and use of asthma medication will be measured by parental questionnaire/medical records.
Time frame: Year 6
Wheeze symptoms up to 3 years of age following RSV infection of different severity
Parent reported wheeze and doctor diagnosis of wheeze by routine care (for active birth cohort and children of passive birth cohort admitted for ARTI).
Time frame: Year 1 - 3
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Rate of all-cause medically attended (inpatient or outpatient) ARTI (active cohort).
Medically attended ARTI is defined as any medical care for a respiratory infection
Time frame: Year 1
RSV associated and all-cause mortality through all RSV seasons of follow up (passive and active cohorts).
Mortality through all RSV seasons of follow up including RSV-associated deaths and all cause deaths.
Time frame: Year 1 - 3
Health care costs and resource use
Health care utilisation for RSV-associated and all-cause medically attended (inpatient or outpatient) ARTI or respiratory events (active birth cohort).
Time frame: Year 1 - 3
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.
The incidence of RSV-associated secondary bacterial pneumonia and associated antibiotic consumption events within 21 days after onset of RSV-related symptoms.
Time frame: Within 21 days of RSV infection
To collect clinical samples (blood, nasopharyngeal, stool and urine) for biomarker analysis (active cohort).
Biomarkers associated with RSV infection in infants
Time frame: Year 1
Incidence rate of other respiratory pathogens (influenza, rhinovirus, human metapneumovirus, parainfluenzavirus, etc.) associated with all medically attended (inpatient or outpatient) ARTI (active cohort).
Additional viruses as detected by PCR testing on nasopharyngeal swab. Medically attended ARTI is defined as any medical care for a respiratory infection.
Time frame: Year 1
Risk factors for RSV infection (by severity and healthcare utilisation) (active and passive cohort).
Demographic risks factors as outlined in CRF/demographic questionnaires
Time frame: Year 1 - 3
The proportion of viral ARTI attributable to RSV (active cohort).
RSV and additional viruses as determined by PCR testing of nasopharyngeal swabs
Time frame: Year 1
Health Related Quality of Life in RSV-associated and all-cause medically attended ARTI patients and their families (active cohort).
Annual questionnaire to families to determine interruption of normal activities associated with RSV and all-cause medically attended ARTI (active cohort).
Time frame: Year 1-3
Risk factors for persistent wheeze at 3 and 6 years of age
Demographic and clinical parameters and outcomes from CRF/demographic questionnaires
Time frame: Year 4,5 and 6