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Febrile Infants - Diagnostic Assessment and Outcome (FIDO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04196192
Recruitment Status : Completed
First Posted : December 12, 2019
Last Update Posted : May 11, 2021
Sponsor:
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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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