Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
2000 participants
OBSERVATIONAL
2017-09-05
2026-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
venepuncture
sample collection for analysis
nasopharyngeal swab
sample collection for analysis
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.
No interventions assigned to this group
Interventions
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venepuncture
sample collection for analysis
nasopharyngeal swab
sample collection for analysis
Eligibility Criteria
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Inclusion Criteria
* Written informed consent obtained from the mother.
* Parents able and willing to adhere to protocol-specified procedures (active cohort).
Exclusion Criteria
* Gestational age of less than 37+0 weeks.
* Acute severe medical condition at moment of sampling (e.g. sepsis, severe asphyxia, for which the child is admitted to the hospital).
* Child in care.
* Parents not able to understand and communicate in the local language.
* Living outside catchment area of study sites.
* Mother vaccinated against RSV during pregnancy (by parental report).
12 Months
ALL
No
Sponsors
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University of Oxford
OTHER
Responsible Party
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Locations
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University of Oxford
Oxford, Oxfordshire, United Kingdom
Countries
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Other Identifiers
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2017/01
Identifier Type: -
Identifier Source: org_study_id
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