A new national trial has been launched to establish the most effective breathing support for babies hospitalised with bronchiolitis.
The £1.7 million BACHbtrial, launched today, is the largest trial of bronchiolitis involving children in this age group to be conducted in the UK and could help to inform national and international guidelines on the care of infants.
The trial, led by researchers at Imperial College London and clinicians at Imperial College Healthcare NHS Trust, will recruit 1508 infants – 924 with moderate and 584 with severe bronchiolitis – over 30 months from children’s emergency departments and wards in 50 hospitals.
Although there are a range of bronchiolitis treatments, it is not clear which is the most effective for moderate and severe cases.
Chief investigator Dr Padmanabhan Ramnarayan, from the Department of Surgery and Cancer at Imperial College London, 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 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.”
Half of children admitted to hospital with bronchiolitis need oxygen treatment through nasal cannula. Although most respond well to that, some need additional breathing support and this could be via humidified standard oxygen (HSO), high-flow nasal cannula (HFNC) or continuous positive airwave pressure (CPAP).
HFNC has generally replaced HSO as a treatment for children with moderate bronchiolitis and it is also widely used in severe bronchiolitis cases as an alternative to CPAP.
However, there is little research to show if HFNC is better than HSO or CPAP. This means there can be variation in practice across the UK.
The research team are to carry out two clinical trials simultaneously 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 switched to an alternative treatment if the one they start with is not found to be effective.
The team will compare the treatments and 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.
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