Bronchiolitis; Respiratory Syncytial Virus Clinical Trial
— BronchSTARTOfficial title:
Impact of Covid-19 on Respiratory Syncytial Virus Seasonality and Disease Severity in UK Children (BronchStart)
| NCT number | NCT04959734 |
| Other study ID # | 140049 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 25, 2021 |
| Est. completion date | July 1, 2024 |
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.
| Status | Recruiting |
| Enrollment | 3000 |
| Est. completion date | July 1, 2024 |
| Est. primary completion date | July 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 0 Years to 2 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University Hospitals of Leicester NHS Trust | Leicester |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospitals, Leicester | Pediatric Emergency Research in the UK and Ireland (PERUKI), Respiratory syncytial virus consortium in Europe |
United Kingdom,
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. — View Citation
Williams TC, Lyttle MD, Cunningham S, Sinha I, Swann OV, Maxwell-Hodkinson A, Marlow R, Roland D; Paediatric Emergency Research in the UK and Ireland (PERUKI). 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. 2022 Jan 21;6:120. doi: 10.12688/wellcomeopenres.16778.2. eCollection 2021. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Disposition | Number of participants recorded via clinician or research nurse completed online case report form who are admitted or discharged from hospital following the initial presentation. | Confirmed at 7 Days following initial presentation | |
| Primary | Intervention | Rate 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 | Confirmed at 7 Days following initial presentation | |
| Primary | Respiratory Syncytial Virus (RSV) Status | Incidence of PCR confirmed RSV status (via PCR) if swabbed up to 7 days following the initial presentation | Confirmed at 7 Days following initial presentation |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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