Febrile Infants - Diagnostic Assessment and Outcome

Completed

• Conditions: Meningitis, Bacterial; Urinary Tract Infections; Bacterial Infections

• Registration Number: NCT04196192
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Study Start: 2020-03-01
• Primary Completion: 2021-03-01
• Status Verified: 2021-05
• Study Completion: 2021-05-01
• Last Update Submitted: 2021-05-08
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 555

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Invasive bacterial infection	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	seven days	Urinary tract infections defined as growth of ≥100 000 cfu/mL

Trial Locations

Locations (6)

Bristol Royal Children's Hospital; 🇬🇧 Bristol, United Kingdom

Royal London Hospital; 🇬🇧 London, United Kingdom

Royal Hospital for Children Glasgow; 🇬🇧 Glasgow, United Kingdom

Leicester Royal Infirmary; 🇬🇧 Leicester, United Kingdom

Children's Health Ireland; 🇮🇪 Dublin, Ireland

Royal Belfast Hospital for Sick Children; 🇬🇧 Belfast, Northern Ireland, United Kingdom