Clinical trial NCT04196192: Febrile Infants - Diagnostic Assessment and Outcome
Official title: Febrile Infants - Diagnostic Assessment and Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningitis, Bacterial
Bacterial Infections
Urinary Tract Infections
Lead sponsor: Belfast Health and Social Care Trust
Sponsor class: OTHER
Collaborators: name: Bristol Royal Hospital for Children
name: University Hospitals, Leicester
name: Barts & The London NHS Trust
name: Children's Health Ireland
name: Royal Hospital for Children Glasgow
name: Royal Belfast Hospital for Sick Children
First posted: 2019-12-12
Enrollment: 555
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants aged 0-90 days (inclusive) with a fever of 38 degrees centigrade or higher recorded in the Emergency Department between the 31/08/2018 and the 01/09/2019.

Brief summary: The purpose of this study is to assess how clinicians apply guidance in the assessment of febrile infants presenting the the Emergency Department. The measurable outcomes are:

Primary Objective Report the rates of serious and invasive bacterial infections in febrile infants

Secondary Objectives Report on the predictive value of different clinical features for predicting bacterial infections.

Report on the value of biomarkers for predicting serious and invasive bacterial infections.

Assess the performance of clinical practice guidelines for the assessment of febrile infants.

Detailed description: The assessment of febrile infants is difficult. In the UK and Ireland current guidance advocates that most children under 3 months of age with a fever undergo a full septic screen including lumbar puncture and receive parenteral antibiotics. Approaches in the United States and Europe including the PECARN and StepByStep approach allow for the discharge home of some low risk young infants.

We intend to assess the current approach to febrile infants and compare that to the available clinical practice guidelines. We also intend to determine which clinical and/or laboratory features are most predictive of serious bacterial infection.

Eligibility criteria: Inclusion Criteria:

* Any infant aged 0 to 90 days (inclusive) with a fever of 38 degrees centigrade or higher recorded in the Emergency Department.

Primary outcomes:
measure: Invasive bacterial infection
timeFrame: seven days
measure: Serious bacterial infections
timeFrame: seven days
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Children's Health Ireland
city: Belfast
country: United Kingdom
facility: Royal Belfast Hospital for Sick Children
state: Northern Ireland
city: Bristol
country: United Kingdom
facility: Bristol Royal Children's Hospital
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Children Glasgow
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Royal London Hospital
Study officials:
References:
citation: Waterfield T, Foster S, Platt R, Barrett MJ, Durnin S, Maney JA, Roland D, McFetridge L, Mitchell H, Umana E, Lyttle MD; Paediatric Emergency Research in the UK and Ireland (PERUKI). Diagnostic test accuracy of dipstick urinalysis for diagnosing urinary tract infection in febrile infants attending the emergency department. Arch Dis Child. 2022 Dec;107(12):1095-1099. doi: 10.1136/archdischild-2022-324300. Epub 2022 Aug 24.
citation: Waterfield T, Lyttle MD, Munday C, Foster S, McNulty M, Platt R, Barrett M, Rogers E, Durnin S, Jameel N, Maney JA, McGinn C, McFetridge L, Mitchell H, Puthucode D, Roland D; Paediatric Emergency Research in the UK and Ireland (PERUKI). Validating clinical practice guidelines for the management of febrile infants presenting to the emergency department in the UK and Ireland. Arch Dis Child. 2022 Apr;107(4):329-334. doi: 10.1136/archdischild-2021-322586. Epub 2021 Sep 16.