FeBRILe3 Project: protocol for a prospective pragmatic, multisite observational study and safety evaluation assessing Fever, Blood cultures and Readiness for discharge in Infants Less than 3 months old

Author:

Mace Ariel OliviaORCID,Martin Andrew C,Ramsay Jessica,Totterdell James,Marsh Julie A,Snelling Tom

Abstract

IntroductionThe purpose of this observational study is to assess the safety and impact of the introduction of a clinical practice guideline (CPG) recommending early discharge of infants with fever without source who are at low risk of serious bacterial infection (SBI). We hypothesise that implementation of this guideline will be associated with a rate of unplanned readmission to hospital (within 7 days of discharge) which is similar (ie, non-inferior) to that observed under previous standard practice.Methods and analysisThis observational study is a prospective pragmatic, multisite safety assessment and impact project. It will evaluate the safety of a CPG which allows febrile infants fulfilling low-risk criteria to be discharged early from hospital if their blood cultures demonstrate no growth at 24 hours (compared with previous minimum 48 hours admission). This guideline has been implemented at two Western Australian metropolitan hospitals. Infants aged <3 months (chronological or corrected for premature birth before 37 weeks gestation) presenting with fever without source will be included. The primary outcome is readmission to hospital due to clinical deterioration/caregiver concern within 7 days of discharge, identified through review of electronic admission details and study-specific caregiver surveys. Secondary outcomes include rates of SBI, hospital lengths of stay compared with previous practice, clinician guideline adherence and caregiver satisfaction with the discharge process. Analysis will be within a sequential Bayesian safety monitoring framework, which incorporates new information and updates the evidence for guideline safety relative to previous practice (historical control) at prespecified interim analyses. Demographic and clinical information will be summarised.Ethics and disseminationEthics approval and waiver of consent for data collection has been granted by the Child and Adolescent Health Service Human Research Ethics Committee (RGS0000001415). Caregivers will have the option to opt out of survey follow-up. Results will be disseminated via peer-reviewed publication.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12619001010189).

Funder

Western Australia Health Translation Network and Australian Government Medical Research Future Fund

National Health and Medical Research Council, Career Development Fellowship

Western Australia Health Research Translation Project 2018 Grant

Australian Government Research Training Program

Publisher

BMJ

Subject

General Medicine

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