A new national trial will aim to determine the most effective breathing support for babies hospitalized with bronchiolitis.
Bronchiolitis is a viral chest infection that affects babies and children under two.
It is usually mild and can be treated at home. However, in some cases symptoms like difficulty with breathing can develop and babies need to be admitted to hospital for treatment. Each year, nearly 30,000 infants under the age of one are admitted to hospitals in England with bronchiolitis.
There are a range of treatments to help babies with their breathing and most babies recover well, but it is not clear which treatment is the most effective for moderate and severe cases of bronchiolitis.
The £1.7 million BACHbtrial, launched today, will recruit 1508 infants (924 with moderate and 584 with severe bronchiolitis) over a 30 month period from children's emergency departments and wards in 50 hospitals. It is led by researchers at Imperial College London and clinicians at Imperial College Healthcare NHS Trust in collaboration with experts across the UK. It is funded by the National Institute for Health and Care Research (NIHR) and supported by the NIHR Imperial Biomedical Research Centre.
It is the largest trial of bronchiolitis involving children in this age group to be conducted in the UK and the findings could inform national and international guidelines on the care of infants.
Dr Padmanabhan Ramnarayan, Chief Investigator of the trial from the Department of Surgery and Cancer at Imperial College London, who is also an Honorary Consultant in Paediatric Intensive Care at Imperial College Healthcare NHS Trust, said:
"Most cases of bronchiolitis are mild and can be treated at home, but unfortunately some babies do develop troubling symptoms like difficulty breathing and need to come into hospital.
"There are a range of options to treat breathing difficulties in babies with bronchiolitis but there is a lack of evidence about which patients would benefit most from each type of treatment. This has led to varying approaches to treating the condition, based on little evidence.
"Our trial aims to answer this question by assessing current treatments and seeing which one provides the most effective breathing support in moderate and severe cases of bronchiolitis.
"The findings from the trial could lead to a change in guidelines on how we treat this condition as well as a reduction in hospital stays. This is particularly vital during the winter period where demands for NHS services increase significantly.
"The treatments in use across the NHS work well. However, we are aiming to find the best approach to treating bronchiolitis so that babies recover faster."
Katy Bridges is a research nurse who will be recruiting patients to the trial at Imperial College Healthcare NHS Trust and also supporting the delivery of the trial at other NHS sites. She said: "Health research can only improve treatment with the help of families so our teams are available in hospitals to support patients every step of the way, by explaining the treatments their child is receiving, helping them to take in information about their child's condition and answering any questions they may have about the study or more widely. The patient's best interests are always the priority."
Half of children admitted to hospital with bronchiolitis need oxygen treatment through 'nasal cannula' (thin tubes inserted into the nostrils) which most infants respond well to. However, some need additional breathing support. In these cases, different treatments are used such as Humidified Standard Oxygen (HSO) - oxygen delivered through a humidifier - High-Flow Nasal Cannula (HFNC) - where oxygen is delivered through tubes into the nostrils - and Continuous Positive Airwave Pressure (CPAP) - for which patients wear an oxygen mask.
HFNC has become a popular treatment in bronchiolitis, as it is seen as more comfortable for children to tolerate and has mostly replaced HSO in infants with moderate bronchiolitis. In many hospitals, HFNC is also used in severe bronchiolitis as an alternative to CPAP but there is little research to show whether HFNC is better than HSO or CPAP.
The lack of evidence means there can be variation in practice across the UK and researchers believe that finding the most effective breathing support may lead to babies recovering more quickly, less discomfort and shorter hospital stays.
Researchers will conduct two clinical trials at the same time to determine the effectiveness of HFNC in moderate and severe bronchiolitis. Infants with moderate bronchiolitis will be randomly allocated to start either HFNC or HSO and those with severe bronchiolitis with either HFNC or CPAP. All other treatment decisions will be left to the clinical team and patients will be quickly switched to an alternative treatment if the one they start with is not found to be effective, so that it does not impact their recovery.
The team will compare the treatments by measuring how quickly infants are discharged from hospitals. They will also study other outcomes such as patient comfort, parent/carer satisfaction, how often infants need admission to intensive care and their health status one and three months later. They will also assess the comparative costs of each treatment.
Two parent representatives from the National Institute of Clinical Excellence (NICE) bronchiolitis guideline committee helped to develop the design of the study through planning meetings and will continue to be involved in the study. There is also an independent parent advisory group with six parents whose children were treated for bronchiolitis. They are advising the research team.
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