About the study
Febrile infants under 3 months of age represent a high-risk group for serious bacterial infection (SBI) with approximately 10-20% having bacteraemia, meningitis or urinary tract infection. The assessment of febrile infants is challenging, and current National Institute for Health and Care Excellence (NICE) guidance advocates a cautious approach with the majority of infants requiring a septic screen, parenteral broad-spectrum antibiotics, and admission to hospital.
Internationally there is significant variation in the approach to febrile infants with European and USA guidance advocating a tailored approach based on clinical features and biomarker testing. None of the available clinical decision (CDAs) have been validated in a UK and Irish cohort.
We are aiming to prospectively validate a range of clinical decision aids in a UK and Irish population, including those that utilise biomarkers like Procalcitonin (PCT) testing i.e. Step-by-step, Pediatric Emergency Care Applied Research Network (PECARN) and American Academy of Pediatrics (AAP). We will be collecting data on patients and clinical assessment methods, and where possible, a small blood sample.
Who can take part?
Any infant 90 days of age or younger who presents to an emergency department with a fever is eligible to join the study.
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How will the study be conducted?
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This will be multicentre observational prospective cohort study in the UK and Ireland conducted via Paediatric Emergency Research in the UK and Ireland (PERUKI) network. Symptoms, clinical features and laboratory results recorded on an electronic case report form by the attending clinician. About 1ml of blood plasma will be collected, during routine phlebotomy, and stored for PCT analysis as well as additional biomarker discovery and validation. These infants will be followed up after 7 days to assess their outcomes (SBI). The study will run for approximately 12 months and aim to recruit 1000 participants. Research without prior consent model will be employed to prioritise optimum management of the febrile infant and make sure care is delivered and the infant is stable prior to initiating consent discussion. A decision analytic model will be constructed to compare the costs of the different approaches (CDAs) where cost will be attributed to resources used in the care of infant. A qualitative study within a trial (SWAT) will be undertaken were parents and clinicians (10 – 20) will be invited to undertake interviews. Parents and clinicians will be interviewed about how the communication of the risk and benefits of different approaches is undertaken. An iterative topic guide will be used for each group to guide discussion. These interviews will be transcribed, and thematic analysis undertaken.
Who is leading the study?
Chief investigator - Dr Thomas Waterfield, Queen’s University Belfast
Doctoral Fellow - Dr Etimbuk Umana, Queen’s University Belfast
Sponsorship and Funding
Queen’s University Belfast is the FIDO study sponsor and the Royal College of Emergency Medicine has provided a Doctoral Fellowship as funding.
Clinical Trial Registry:
https://clinicaltrials.gov/ct2/show/NCT05259683
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NIHR Portfolio Information:
CPMS ID: 53493
Assoicate PI NIHR confirmation
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The current version of the FIDO Protocol can be downloaded here