Febrile Infants - Diagnostic assessment and Outcome (FIDO)
Research type
Research Study
Full title
Validating clinical decision aids for the assessment and management of febrile infants presenting to emergency care in the UK and Ireland. Febrile Infants - Diagnostic assessment and Outcome (FIDO)
IRAS ID
278080
Contact name
Thomas Waterfield
Contact email
Sponsor organisation
Queen's University Belfast
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Summary of Research
Young febrile infants (under 3 months of age) represent a high-risk group for paediatric sepsis, serious bacterial infection and death. Safety mandates a cautious approach to these infants with many receiving parenteral broad-spectrum antibiotics and undergoing painful procedure such as blood tests and lumbar puncture. The ideal approach to the assessment and management of this vulnerable group of patients isn’t clear with a range of clinical approaches with some advocating treatment of all febrile infants and others advocating for discharge home of a low risk group without treatment. The aim of this study is to assess current UK practice and prospectively validate clinical decision aids (CDAs). In addition, we intend to explore how new blood test could be used to enhance current clinical practice. We plan to recruit infants under 3 months of age presenting with a fever and suspected serious bacterial infection to the emergency department. All infants will get emergency clinical care as usual without delays.Because the management of possible sepsis is time critical, we will use a method of delayed consent from the parents/guardians which is nationally accepted. During routine care and blood testing, children will have 1 ml of blood taken that will be saved for evaluating new blood tests. We will follow up these infants for seven days to see which of them develops serious bacterial infection. Parents and doctors will be interviewed about how the communication of the risk and benefits of different approaches is undertaken. We will also look at the cost of various approaches and which would be most cost-effective for our population in UK and Ireland. Our results will be published in scientific journals, presented at conferences and used to inform future guidelines for managing febrile infants.
Summary of Results
This study examines how well different clinical decision aids work for assessing febrile infants (babies with fever) in emergency departments across the UK and Ireland. The research will collect data from 35 hospitals over a July 2022 to August 2023. The study includes taking blood samples during routine care and interviewing parents and doctors about their experiences. The main goal is to find better ways to identify invasive bacterial infections (sepsis and meningitis) in young infants, while also understanding how doctors and parents make decisions about treatment. This could help improve care for febrile infants in emergency settings.REC name
HSC REC B
REC reference
22/NI/0002
Date of REC Opinion
17 Feb 2022
REC opinion
Further Information Favourable Opinion