Fever in young infants (babies up to 90 days of age) is a common reason for emergency department (ED) visits and can be a sign of serious infections such as meningitis or sepsis. Currently, invasive (painful) procedures such as blood tests and lumbar punctures (a procedure in which a needle is placed into the back to obtain spinal fluid) are commonly used to rule out these infections. Most infants are also treated with antibiotics and admitted to the hospital.
Often, fever in infants is caused by viral infections that do not require such invasive interventions. Recent evidence has shown that viral tests, performed via a simple nose swab, can be used to identify infants who may not need invasive procedures or antibiotics.
The aim of this study is to determine whether rapid testing for three common viruses; RSV (Respiratory Syncytial Virus), COVID (SARS-CoV-2), and Flu (Influenza)—can reduce the number of invasive procedures, time spent in the ED, hospital admission and antibiotic use. Rapid tests are available that only require a swabs from the nose or throat and provide quick results in the ED (results within hour).
To investigate this fully a larger study is required, not only within Wales but across the UK. Before undertaking such a large study a smaller ‘pilot’ study is needed to assess if it is possible to conduct the larger one to a high standard. Large trials are also expensive and a smaller study helps to ensure government funding is used appropriately. This pilot study aims to evaluate if it is possible to deliver a larger study, by collecting information on numbers of people willing to take part, how clinicians use the test, and if the test has any effect on the outcomes above.
During the smaller study, infants aged 29 to 90 days of age will be randomly allocated to either receive the current care without a viral test or to the usual care AND the viral test. The study will not change any other parts of care, that will be left to the doctors and nurses.
When designing this smaller ‘pilot’ study the study team have spoken with parents and caregivers to ensure the design includes what matters most to them. Throughout the study members of the public will be involved with designing the protocol, patient leaflets and how we communicate the findings.
This research fits with what the Welsh public and Welsh Government have said is important to improve children’s healthcare. It also fits with the UK government's views on the need to reduce antibiotic use where it is safe to do so. If successful, the findings could guide how babies with fever are cared for across Wales, the UK and Ireland.