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COVID-19 Impact on RSV Emergency Presentations

Impact of Covid-19 on Respiratory Syncytial Virus Seasonality and Disease Severity in UK Children (BronchStart)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04959734
Acronym
BronchSTART
Enrollment
3000
Registered
2021-07-13
Start date
2021-06-25
Completion date
2026-03-27
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis; Respiratory Syncytial Virus

Keywords

Bronchiolitis, RSV, Vaccine Effectiveness

Brief summary

Bronchiolitis is a very common winter disease that normally affects children less than one year of age. It is a common reason for parents and carers to bring their child to an Emergency Department (ED) and the frequent need for hospital admission means that paediatric units are at their capacity each winter. 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.

Interventions

None listed

Sponsors

Respiratory syncytial virus consortium in Europe
CollaboratorUNKNOWN
Pediatric Emergency Research in the UK and Ireland (PERUKI)
CollaboratorOTHER
University Hospitals, Leicester
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 2 Years
Healthy volunteers
No

Inclusion criteria

i) Children under two years of age presenting to participating emergency departments with clinical features of: * 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

i) Children with previous episodes of wheeze responsive to bronchodilator (suggesting an underlying diagnosis of recurrent wheeze of early childhood)

Design outcomes

Primary

MeasureTime frameDescription
DispositionConfirmed at 7 Days following initial presentationNumber of participants recorded via clinician or research nurse completed online case report form who are admitted or discharged from hospital following the initial presentation.
InterventionConfirmed at 7 Days following initial presentationRate of intervention in participants {Nasogastric Feed, Intravenous Fluids, Oxygen, High Flow Humidified Oxygen, CPAP or Mechanical Ventilation} determined by case note extraction and recorded by an online case report form up to 7 days following the initial presentation
Respiratory Syncytial Virus (RSV) StatusConfirmed at 7 Days following initial presentationIncidence of PCR confirmed RSV status (via PCR) if swabbed up to 7 days following the initial presentation

Countries

United Kingdom

Contacts

Primary ContactDamian Roland, BMBS PhD
dr98@leicester.ac.uk07950891367
Backup ContactThomas Williams
Thomas.Christie.Williams@ed.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026