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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

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.

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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

Resource links provided by the National Library of Medicine


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



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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04196192


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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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