COVID-19 Impact on RSV Emergency Presentations

NCT04959734 | Recruiting

• 1 other identifier: 140049
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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. 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. 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;

Conditions

Bronchiolitis; Respiratory Syncytial Virus

Keywords

Bronchiolitis; RSV; Vaccine Effectiveness

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Bronchiolitis

Infants less than 2 years who the clinician has diagnosed Bronchiolitis

LRTI

Infants less than 2 years who the clinician has diagnosed a viral or bacterial lower respiratory tract infection

Wheeze

Infants less than 2 years who the clinician has diagnosed the first presentation of a viral wheeze

Eligibility Criteria

• Age: 0 Years - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children under two years of age attending emergency departments across the UK and Ireland

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospitals, Leicester: lead
• Respiratory syncytial virus consortium in Europe: collaborator
• Pediatric Emergency Research in the UK and Ireland (PERUKI): collaborator

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

RECRUITING

Related Publications (3)

• 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.

  PMID: 39052749 RESULT

• 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.

  PMID: 34458589 RESULT

• 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.

  PMID: 36261149 RESULT

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Damian Roland, BMBS PhD

  University Hospitals, Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damian Roland, BMBS PhD

CONTACT

07950891367; dr98@leicester.ac.uk

Thomas Williams

CONTACT

Thomas.Christie.Williams@ed.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 13, 2021
• Study Start: June 25, 2021
• Primary Completion: March 27, 2026
• Study Completion: March 27, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)