Bronchiolitis; Respiratory Syncytial VirusBronchSTARTNCT04959734
COVID-19 Impact on RSV Emergency Presentations
An observational study of Bronchiolitis; Respiratory Syncytial Virus, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 2 years
- Conditions the study is for
- Bronchiolitis; Respiratory Syncytial Virus
- How many people
- 3,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jun 2021to 27 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Children under two years of age attending emergency departments across the UK and Ireland
Who may be able to join
- 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.
Who cannot join
- Children with previous episodes of wheeze responsive to bronchodilator (suggesting an underlying diagnosis of recurrent wheeze of early childhood)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas Williams contact
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals of Leicester NHS Trust
Leicester
Damian Roland, 07950891367, dr98@leicester.ac.uk
About this study
Official title: Impact of Covid-19 on Respiratory Syncytial Virus Seasonality and Disease Severity in UK Children (BronchStart)
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.
Read more
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:
- 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.
- 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.
- Keywords
- Bronchiolitis, RSV, Vaccine Effectiveness
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Confirmed at 7 Days following initial presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start25 Jun 2021
- Primary completion27 Mar 2026 (estimated)
- Study completion27 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bronchiolitis; Respiratory Syncytial VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Respiratory syncytial virus consortium in Europe, Pediatric Emergency Research in the UK and Ireland (PERUKI)
- Responsible party
- Sponsor
- Investigators
- Damian Roland, BMBS PhD, Principal investigator, University Hospitals, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959734
- Sponsor's protocol ID
- 140049
- Acronym
- BronchSTART
- Status last verified
- Dec 2025
- First submitted
- 9 Jul 2021
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Identifiable information is not collected as part of this study. The anonymised central database will be available on reasonable request.
Publications
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.
PubMed 39052749Williams 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.
PubMed 34458589Roland 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.
PubMed 36261149O'Hagan S, Cunningham S, Drysdale SB, Groves HE, Hunt S, Iskander D, Liu X, Lyttle MD, Mpamhanga CD, Waterfield T, Williams TC, Marlow R, Roland D; Paediatric Emergency Research UK and Ireland (PERUKI) and BronchStart Collaboration. A national programme of bivalent prefusion F vaccination in pregnancy and protection against respiratory syncytial virus hospitalisation in infants until age 6 months in the UK: a multicentre, prospective, test-negative, case-control study. Lancet Child Adolesc Health. 2026 Sep;10(9):637-646. doi: 10.1016/S2352-4642(26)00134-3. Epub 2026 Jul 1.
PubMed 42385756
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Covid-19 on Respiratory Syncytial Virus Seasonality and Disease Severity in UK Children (BronchStart)
- ClinicalTrials.gov ID
- NCT04959734
- Acronym / sponsor ID
- BronchSTART / 140049
- Keywords
- Bronchiolitis, RSV, Vaccine Effectiveness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- Respiratory syncytial virus consortium in Europe, Pediatric Emergency Research in the UK and Ireland (PERUKI)
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 27 Mar 2026 (estimated)
- Study completion
- 27 Mar 2026 (estimated)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 0 to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under two years of age attending emergency departments across the UK and Ireland
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Children with previous episodes of wheeze responsive to bronchodilator (suggesting an underlying diagnosis of recurrent wheeze of early childhood)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disposition
Time frame: Confirmed at 7 Days following initial presentation
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.
Intervention
Time frame: Confirmed at 7 Days following initial presentation
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
Respiratory Syncytial Virus (RSV) Status
Time frame: Confirmed at 7 Days following initial presentation
Incidence of PCR confirmed RSV status (via PCR) if swabbed up to 7 days following the initial presentation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Results publication: PubMed 39052749Williams 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.
- Results publication: PubMed 34458589Williams 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.
- Results publication: PubMed 36261149Roland 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.
- Derived from this study: PubMed 42385756O'Hagan S, Cunningham S, Drysdale SB, Groves HE, Hunt S, Iskander D, Liu X, Lyttle MD, Mpamhanga CD, Waterfield T, Williams TC, Marlow R, Roland D; Paediatric Emergency Research UK and Ireland (PERUKI) and BronchStart Collaboration. A national programme of bivalent prefusion F vaccination in pregnancy and protection against respiratory syncytial virus hospitalisation in infants until age 6 months in the UK: a multicentre, prospective, test-negative, case-control study. Lancet Child Adolesc Health. 2026 Sep;10(9):637-646. doi: 10.1016/S2352-4642(26)00134-3. Epub 2026 Jul 1.
- Individual participant dataSharing planned: No. Identifiable information is not collected as part of this study. The anonymised central database will be available on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Williams contact
Damian Roland, BMBS PhD principal investigator
University Hospitals, Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis; Respiratory Syncytial Virus, run by University Hospitals, Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damian Roland, BMBS PhD (07950891367, dr98@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disposition (time frame: Confirmed at 7 Days following initial presentation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04959734, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.