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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RECRUITING
3000 participants
OBSERVATIONAL
2021-06-25
2026-03-27
Brief Summary
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During the COVID19 pandemic the virus that causes bronchiolitis (Respiratory Syncytial Virus; RSV) disappeared meaning this winter there have been virtually no cases of bronchiolitis in the United Kingdom. This phenomenon has been observed in many other countries around the world. Evidence from Australia suggests as restrictions such as social distancing for COVID19 are relaxed bronchiolitis returns, even in the summer. At the release of lockdown the return has been so dramatic in some areas of Australia the summer time numbers are above a typical winter. There is also evidence it may affect older children up to 2 years of age.
It is likely the Australian experience will be mirrored in the UK. The ability to track, anticipate and respond to a surge in bronchiolitis is important. There is a need to understand:
1. the onset of RSV spread at the earliest opportunity. This is important as some children are at higher risk of hospitalisation, intensive care admission or death if they contract RSV; knowing when to passively immunise these children is a public health priority.
2. whether the population at risk is a wider age range than normal and whether disease severity is greater as these will both effect service planning;
There are currently no existing studies or surveillance systems fully able to address these questions. This study will use staff in Emergency Department to report, in real time, case of bronchiolitis that they see and record essential, but non-identifying, information about them.
In 2022/23 the study evolved from a prospective surveillance study into a genomic analysis study with sites collecting positive respiratory samples for RSV genomic review.
In 2024/25 the study was amended in light of the introduction of the Bivalent Prefusion F Vaccine in Pregnancy in the United Kingdom to undertake a Vaccine Effectiveness study.
The main inclusion criteria remains the same but mothers who would have been eligible for the vaccine, and deliver an infant during the RSV season, were consented to obtain vaccination details so these could be linked to BronchSTART records.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Bronchiolitis
Infants less than 2 years who the clinician has diagnosed Bronchiolitis
No interventions assigned to this group
LRTI
Infants less than 2 years who the clinician has diagnosed a viral or bacterial lower respiratory tract infection
No interventions assigned to this group
Wheeze
Infants less than 2 years who the clinician has diagnosed the first presentation of a viral wheeze
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Bronchiolitis (cough, tachypnoea or chest recession, and wheeze or crackles on chest auscultation) or
* Lower Respiratory Tract infection or
* Afirst episode of acute viral wheeze.
Exclusion Criteria
0 Years
2 Years
ALL
No
Sponsors
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Respiratory syncytial virus consortium in Europe
UNKNOWN
Pediatric Emergency Research in the UK and Ireland (PERUKI)
OTHER
University Hospitals, Leicester
OTHER
Responsible Party
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Principal Investigators
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Damian Roland, BMBS PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals, Leicester
Locations
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University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Williams TC, Marlow R, Hardelid P, Lyttle MD, Lewis KM, Mpamhanga CD, Cunningham S, Roland D; PERUKI. Clinical Impact of Serious Respiratory Disease in Children Under the Age of 2 Years During the 2021-2022 Bronchiolitis Season in England, Scotland, and Ireland. J Infect Dis. 2024 Jul 25;230(1):e111-e120. doi: 10.1093/infdis/jiad551.
Williams TC, Cunningham S, Drysdale SB, Groves H, Iskander D, Liu X, Lyttle MD, Marlow R, Maxwell-Hodkinson A, Mpamhanga CD, O'Hagan S, Sinha I, Swann OV, Waterfield T, Roland D; Paediatric Emergency Research in the UK and Ireland (PERUKI). Update to: Study Pre-protocol for "BronchStart - The Impact of the COVID-19 Pandemic on the Timing, Age and Severity of Respiratory Syncytial Virus (RSV) Emergency Presentations; a Multi-Centre Prospective Observational Cohort Study". Wellcome Open Res. 2024 Dec 18;6:120. doi: 10.12688/wellcomeopenres.16778.4. eCollection 2021.
Roland D, Williams T, Lyttle MD, Marlow R, Hardelid P, Sinha I, Swann O, Maxwell-Hodkinson A, Cunningham S. Features of the transposed seasonality of the 2021 RSV epidemic in the UK and Ireland: analysis of the first 10 000 patients. Arch Dis Child. 2022 Nov;107(11):1062-1063. doi: 10.1136/archdischild-2022-324241. Epub 2022 Sep 2. No abstract available.
Other Identifiers
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140049
Identifier Type: -
Identifier Source: org_study_id
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