Febrile Infants - Diagnostic Assessment and Outcome (FIDO)

• ClinicalTrials.gov Identifier: NCT04196192
• Recruitment Status: Completed
• First Posted: December 12, 2019
• Last Update Posted: May 11, 2021
• Sponsor: Belfast Health and Social Care Trust
• Collaborators: Bristol Royal Hospital for Children; University Hospitals, Leicester; Barts & The London NHS Trust; Children's Health Ireland; Royal Hospital for Children Glasgow; Royal Belfast Hospital for Sick Children
• Information provided by (Responsible Party): Thomas Waterfield, Belfast Health and Social Care Trust

Study Description

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.

Condition or disease
Meningitis, Bacterial; Bacterial Infections; Urinary Tract Infections

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 Design

• Study Type: Observational
• Actual Enrollment: 555 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Febrile Infants - Diagnostic Assessment and Outcome
• Actual Study Start Date: March 1, 2020
• Actual Primary Completion Date: March 1, 2021
• Actual Study Completion Date: May 1, 2021

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Invasive bacterial infection [ Time Frame: seven days ]
   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.
2. Serious bacterial infections [ Time Frame: seven days ]
   Urinary tract infections defined as growth of ≥100 000 cfu/mL

Eligibility Criteria

• Ages Eligible for Study: up to 90 Days (Child)
• Sexes 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.

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.

Contacts and Locations

Locations

Ireland

Children's Health Ireland

Dublin, Ireland

United Kingdom

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, United Kingdom, BT126BE

Bristol Royal Children's Hospital

Bristol, United Kingdom

Royal Hospital for Children Glasgow

Glasgow, United Kingdom

Leicester Royal Infirmary

Leicester, United Kingdom

Royal London Hospital

London, United Kingdom

Sponsors and Collaborators

Belfast Health and Social Care Trust

Bristol Royal Hospital for Children

University Hospitals, Leicester

Barts & The London NHS Trust

Children's Health Ireland

Royal Hospital for Children Glasgow

Royal Belfast Hospital for Sick Children

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Thomas Waterfield, Doctor, Belfast Health and Social Care Trust
• ClinicalTrials.gov Identifier: NCT04196192
• Other Study ID Numbers: QIP10/12/19HJ
• First Posted: December 12, 2019
• Last Update Posted: May 11, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Anonymised datasets not containing any personal data will be available after publication

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infections; Communicable Diseases; Urinary Tract Infections; Bacterial Infections; Meningitis, Bacterial; Meningitis; Disease Attributes; Pathologic Processes; Urologic Diseases; Central Nervous System Diseases; Nervous System Diseases; Bacterial Infections and Mycoses; Central Nervous System Bacterial Infections; Central Nervous System Infections