Febrile Infants - Diagnostic Assessment and Outcome (FIDO)

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Infections; Urinary Tract Infections; Meningitis, Bacterial

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.

• Study Type: Observational
• Enrollment (Actual): 555

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • Children's Health Ireland
• United Kingdom
  • Bristol, United Kingdom
    • Bristol Royal Children's Hospital
  • Glasgow, United Kingdom
    • Royal Hospital for Children Glasgow
  • Leicester, United Kingdom
    • Leicester Royal Infirmary
  • London, United Kingdom
    • Royal London Hospital
  • Northern Ireland
    • Belfast, Northern Ireland, United Kingdom, BT126BE
      • Royal Belfast Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Group 1; All infants aged 0-90 days (inclusive) undergoing routine assessments for fever without source.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive bacterial infection	Invasive Bacterial Infection (non-contaminant) confirmed by culture or molecular diagnostic testing of a sterile site i.e. blood or cerebrospinal fluid (CSF). Staphylococcus epidermidis, Propionibacterium acnes, Streptococcus viridans, or Diphtheroides were considered contaminants.	seven days
Serious bacterial infections	Urinary tract infections defined as growth of ≥100 000 cfu/mL	seven days

Collaborators and Investigators

• Sponsor: Belfast Health and Social Care Trust
• Collaborators: Barts & The London NHS Trust; University Hospitals, Leicester; Bristol Royal Hospital for Children; Children's Health Ireland; Royal Hospital for Children Glasgow; Royal Belfast Hospital for Sick Children

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ACTUAL): March 1, 2021
• Study Completion (ACTUAL): May 1, 2021

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (ACTUAL): December 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 8, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Disease Attributes; Central Nervous System Infections; Bacterial Infections and Mycoses; Central Nervous System Bacterial Infections; Infections; Communicable Diseases; Urinary Tract Infections; Meningitis; Bacterial Infections; Meningitis, Bacterial
• Other Study ID Numbers: QIP10/12/19HJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised datasets not containing any personal data will be available after publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No