Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001010189
Ethics application status
Approved
Date submitted
3/07/2019
Date registered
15/07/2019
Date last updated
24/11/2020
Date data sharing statement initially provided
15/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
FeBRILe3 Project - Fever, Blood cultures and Readiness for discharge in Infants Less than 3 months old.
Scientific title
FeBRILe3 Project - Fever, Blood cultures and Readiness for discharge in Infants Less than 3 months old.
A prospective safety monitoring programme of a safety cohort of low risk infants less than 3 months old admitted with fever without source after the implementation of a new clinical practice guideline allowing for early discharge of well-appearing, low-risk infants.
Secondary ID [1] 298561 0
CVID/2018-03
Universal Trial Number (UTN)
Trial acronym
FeBRILe3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infant fever 313395 0
serious bacterial infections 313396 0
Condition category
Condition code
Infection 311826 311826 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This project will prospectively monitor a cohort of low risk infants less than 3 months old admitted with fever without source after the implementation of a new clinical practice guideline allowing for early discharge of well-appearing, low risk infants. This clinical practice guideline was created by the General Paediatric Departments at Perth Children's Hospital and Fiona Stanley Hospital based on evidence from the literature, indicating that most low-risk infants who warrant hospitalisation can be safely discharged after 24 hours (Biondi 2015, Gomez 2016), and has been implemented at both hospitals. The FeBRILe3 project has been designed as an adjunct to the implemented guideline to monitor patient outcomes and safety prospectively following changes in healthcare policy, rather than delayed retrospective review of outcomes after a period of time post-implementation.

As per the implemented clinical practice guideline, infants admitted for investigation of fever without source will be eligible for discharge after 24 hours if they fulfil all low-risk criteria and have no growth on blood cultures at 24 hours. Low-risk criteria include: i) age greater than or equal to 29 days, ii) absence of pyuria (no white cells in urine, i.e. <10 per high powered field), iii) CRP < 20 mg/l, iv) absolute neutrophil count (ANC) < 10 x 10^9/L and white cell count (WCC) between 4 x 10^9/L and 15 x 10^9/L, v) have not received antibiotics within 48 hours prior to admission and vi) appear well on examination. High risk infants (appearing unwell/toxic, < 28 days old, or with significant medical comorbidities), those who remain clinically unwell or who have investigative tests suggestive of a serious bacterial infection (e.g. urinary tract infection, bacteraemia or meningitis) will be admitted for a minimum of 48 hours, with management directed by clinical status as per current practice.

The safety of this new clinical practice guideline allowing early discharge of low-risk infants will be determined by active monitoring of unplanned hospital re-presentation/readmissions rates within 7 days of discharge (through electronic admission details and care-giver surveys) for the first 500 patients (for a study period of up to 24 months) after implementation of the new clinical practice guideline. Baseline demographic and clinical information will be collected for all infants aged less than 3 months old (chronological or corrected for premature birth before 37 weeks gestation) admitted to hospital for the investigation and management of fever. Care-givers will have the option to opt out of SMS/telephone survey follow-up.

Biondi EA, Byington CL. Evaluation and Management of Febrile, Well-appearing Young Infants. Infectious Disease Clinics of North America. 2015;29(3):575-585.
Gomez B, Mintegi S, Bressan S, et al. Validation of the "Step-by-Step" Approach in the Management of Young Febrile Infants. Pediatrics. Aug 2016;138(2).
Intervention code [1] 314814 0
Early Detection / Screening
Comparator / control treatment
The observed rate of readmission within 7 days of discharge will be assessed at specified time-points against a pre-set acceptability threshold for readmissions. This threshold was derived from a retrospective population-based data-linkage study of the 8,250 children aged less than 3 months old (from a Perth metropolitan birth cohort of 11,670) who were hospitalized between 2008 – 2012. This cohort was analysed to identify the rate of readmissions within 7 days of discharge for all infants less than 3 months old (chronological or corrected for premature birth before 37 weeks gestation) with fever without source to any WA Metropolitan hospital.
Control group
Historical

Outcomes
Primary outcome [1] 320531 0
The primary outcome is readmission to hospital due to a clinical deterioration/care-giver concern within 7 days of discharge.
This outcome will be assessed by: i) review of the electronic admission details for all participants 7-10 days after discharge to monitor for events occurring within 7 days of discharge and ii) surveying the parent/legally responsible care-giver 7-10 after discharge from hospital to ask directly about outcomes. Surveys will initially be sent electronically and followed up with phone contact, if required. This survey was designed specifically for this study.
Timepoint [1] 320531 0
7 days after discharge from hospital.
Secondary outcome [1] 371933 0
Rates of serious bacterial infection, such as urinary tract infection, bacteraemia, and/or bacterial meningitis, confirmed within 7 days of hospitalisation.
This outcome will be assessed by identification of all positive microbiological specimens (urine, blood and cerebrospinal fluid) through review of electronic patient results for all enrolled patients.
Timepoint [1] 371933 0
Within 7 days of hospital admission
Secondary outcome [2] 371934 0
Change in overall hospital length of stay compared to historical control group.
This outcome will be assessed from the date and time of admission and discharge as recorded in the hospitals' patient information systems
Timepoint [2] 371934 0
Calculated on discharge from hospital (completion of hospital admission)
Secondary outcome [3] 371935 0
Care-giver satisfaction with discharge process including early discharge (if applicable) ascertained by care-giver survey. This survey has been designed specifically for this study.
Timepoint [3] 371935 0
7-10 days post discharge from hospital

Eligibility
Key inclusion criteria
1. Aged less than 90 days chronological age for term infants; or less than 90 days since 40 weeks gestation if born before 37 weeks gestation
2. Admitted to participating hospital for the primary reason of investigation and management of fever without source
Minimum age
0 Days
Maximum age
90 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any infant never separated from hospital since birth.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The observed rate of readmission within 7 days of discharge will be assessed at specified time-points against a pre-set acceptability threshold (derived from retrospective data analysis) using a sequential Bayesian safety monitoring framework. The sequential Bayesian monitoring incorporates new information as the project progresses and updates the current evidence for safety of the guideline at pre-specified interim analyses. The first analysis will take place when follow-up is available for 100 individuals, with each subsequent analysis occurring when follow-up is available on an additional 50 individuals up to the maximum of 500.
Individual demographic, clinical and laboratory information will be reported. Categorical variables will be summarised as frequency and percentage. Continuous variables will be summaries as mean and standard deviation for symmetric distributions and median and interquartile range for asymmetric distributions.
Care-giver satisfaction will be captured in a 5 point Likert scale and reported as frequency and percentage for each category.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/08/2019
Actual
6/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
176
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 14084 0
Perth Children's Hospital - Nedlands
Recruitment hospital [2] 14085 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 26875 0
6009 - Nedlands
Recruitment postcode(s) [2] 26876 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 303101 0
Government body
Name [1] 303101 0
The Government of Western Australia, Department of Health
Country [1] 303101 0
Australia
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
Northern Entrance, Perth Children's Hospital, 15 Hospital Ave, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 303091 0
None
Name [1] 303091 0
Address [1] 303091 0
Country [1] 303091 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303646 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 303646 0
Ethics committee country [1] 303646 0
Australia
Date submitted for ethics approval [1] 303646 0
04/04/2019
Approval date [1] 303646 0
02/05/2019
Ethics approval number [1] 303646 0
RGS1415

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94382 0
Dr Andrew Martin
Address 94382 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands Western Australia 6009
Country 94382 0
Australia
Phone 94382 0
+61 8 64562222
Fax 94382 0
Email 94382 0
[email protected]
Contact person for public queries
Name 94383 0
Andrew Martin
Address 94383 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands Western Australia 6009
Country 94383 0
Australia
Phone 94383 0
+61 8 6456 2222
Fax 94383 0
Email 94383 0
[email protected]
Contact person for scientific queries
Name 94384 0
Tom Snelling
Address 94384 0
Wesfarmers Centre of Vaccines and Infectious Diseases
Telethon Kids Institute
PO Box 855
West Perth, WA 6872
Country 94384 0
Australia
Phone 94384 0
+61 8 63191817
Fax 94384 0
Email 94384 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD sharing is subject to necessary additional approvals


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2479Study protocol    The study protocol will be submitted for journal p... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFeBRILe3 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.2020https://dx.doi.org/10.1136/bmjopen-2019-035992
N.B. These documents automatically identified may not have been verified by the study sponsor.