Clinical trial NCT04959734: COVID-19 Impact on RSV Emergency Presentations
Official title: Impact of Covid-19 on Respiratory Syncytial Virus Seasonality and Disease Severity in UK Children (BronchStart)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchiolitis; Respiratory Syncytial Virus
Keywords: Bronchiolitis
RSV
Vaccine Effectiveness
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
Collaborators: name: Respiratory syncytial virus consortium in Europe
name: Pediatric Emergency Research in the UK and Ireland (PERUKI)
First posted: 2021-07-13
Enrollment: 3000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under two years of age attending emergency departments across the UK and Ireland

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Disposition
timeFrame: Confirmed at 7 Days following initial presentation
measure: Intervention
timeFrame: Confirmed at 7 Days following initial presentation
measure: Respiratory Syncytial Virus (RSV) Status
timeFrame: Confirmed at 7 Days following initial presentation
Secondary outcomes:
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
Study officials:
affiliation: University Hospitals, Leicester
name: Damian Roland, BMBS PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.