Febrile Infants - Diagnostic Assessment and Outcome

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.

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Key information

Conditions

Meningitis, Bacterial Bacterial Infections Bacterial Infections and Mycoses Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Meningitis Nervous System Diseases Neuroinflammatory Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

Up to 90 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Health Ireland, Dublin, Ireland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Any infant aged 0 to 90 days (inclusive) with a fever of 38 degrees centigrade or higher recorded in the Emergency Department.

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Belfast Health and Social Care Trust

Other

Collaborators

Barts & The London NHS Trust
Bristol Royal Hospital for Children
Children's Health Ireland
Royal Belfast Hospital for Sick Children
Royal Hospital for Sick Children
University Hospitals, Leicester

Registry information

Acronym: FIDO

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Dec 12, 2019
Registry last updated: May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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