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

Tracking Information

• First Submitted Date: December 10, 2019
• First Posted Date: December 12, 2019
• Last Update Posted Date: May 11, 2021
• Actual Study Start Date: March 1, 2020
• Actual Primary Completion Date: March 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 12, 2021)

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

Original Primary Outcome Measures (submitted: December 10, 2019)

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). Contaminants defined as: Staphylococcus epidermidis, Propionibacterium acnes, Streptococcus viridans, Diphtheroides

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Febrile Infants - Diagnostic Assessment and Outcome
• Official Title: Febrile Infants - Diagnostic Assessment and Outcome

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Meningitis, Bacterial
• Bacterial Infections
• Urinary Tract Infections

• Intervention: Not Provided

Study Groups/Cohorts

Group 1

All infants aged 0-90 days (inclusive) undergoing routine assessments for fever without source.

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 8, 2021): 555
• Original Estimated Enrollment (submitted: December 10, 2019): 200
• Actual Study Completion Date: May 1, 2021
• Actual Primary Completion Date: March 1, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 90 Days (Child)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Ireland, United Kingdom

Administrative Information

• NCT Number: NCT04196192
• Other Study ID Numbers: QIP10/12/19HJ
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

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

• Current Responsible Party: Thomas Waterfield, Belfast Health and Social Care Trust
• Original Responsible Party: Same as current
• Current Study Sponsor: Belfast Health and Social Care Trust
• Original Study Sponsor: Same as current

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

• Investigators: Not Provided
• PRS Account: Belfast Health and Social Care Trust
• Verification Date: May 2021