An observational study in Bronchiolitis; Respiratory Syncytial Virus, sponsored by University Hospitals, Leicester. Recruiting at 1 site in United Kingdom. Open to participants aged 0 Years to 2 Years. Per ClinicalTrials.gov, last updated 2026-01-05.
Sponsored by University Hospitals, Leicester · Observational
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:
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.
289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 200 across 79 observational studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →University Hospitals, Leicester is the lead sponsor of 68 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children under two years of age attending emergency departments across the UK and Ireland
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
i) Children under two years of age presenting to participating emergency departments with clinical features of:
Exclusion Criteria:
i) Children with previous episodes of wheeze responsive to bronchodilator (suggesting an underlying diagnosis of recurrent wheeze of early childhood)
Infants less than 2 years who the clinician has diagnosed Bronchiolitis
Infants less than 2 years who the clinician has diagnosed a viral or bacterial lower respiratory tract infection
Infants less than 2 years who the clinician has diagnosed the first presentation of a viral wheeze
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.
Time frame: 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
Time frame: 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
Time frame: Confirmed at 7 Days following initial presentation
Plan to share: No — Identifiable information is not collected as part of this study. The anonymised central database will be available on reasonable request.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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University Hospitals, Leicester