An observational study in Respiratory Syncytial Virus Infections and RSV Infection, sponsored by University of Oxford. Active, not recruiting at 1 site in United Kingdom. Open to participants aged Up to 12 Months. Per ClinicalTrials.gov, last updated 2022-10-27.
Sponsored by University of Oxford · Observational
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.
302 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 48 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 350 across 76 observational studies indexed under Respiratory Syncytial Virus Infections.
Browse Respiratory Syncytial Virus Infections studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
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Healthy children, gestation age at least 37+0 weeks, born at participating centres and recruited within the first week of life.
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Exclusion Criteria:
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.
Procedure: venepuncture · Procedure: nasopharyngeal swab
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.
sample collection for analysis
sample collection for analysis
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
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
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2017 (actual). Primary completion is estimated for Nov 2026, 110 months after the start.
Of 32 observational studies under Respiratory Syncytial Virus Infections, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 51. This study's planned 110 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Respiratory Syncytial Virus Infections →