Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-06-26 @ 5:11 AM
Study NCT ID:
NCT04196192
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2019-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Febrile Infants - Diagnostic Assessment and Outcome
Sponsor:
Belfast Health and Social Care Trust
Organization:
Study Overview
Official Title:
Febrile Infants - Diagnostic Assessment and Outcome
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIDO
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: