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Trial registered on ANZCTR


Registration number
ACTRN12620001340921
Ethics application status
Approved
Date submitted
21/09/2020
Date registered
14/12/2020
Date last updated
29/10/2021
Date data sharing statement initially provided
14/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Parental and Healthcare Professional Concern in the Diagnosis of Paediatric Sepsis
Scientific title
Parental and Healthcare Professional Concern in the Diagnosis of Paediatric Sepsis: A Prospective Multicentre Observational Study
Secondary ID [1] 301941 0
Nil known
Universal Trial Number (UTN)
U1111-1256-4537
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Sepsis 318486 0
Serious Bacterial Infection 318487 0
Condition category
Condition code
Infection 316489 316489 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Determining diagnostic accuracy of concern levels in parents, doctors and nurses to recognise paediatric sepsis by study-specific questionnaire completion. This will take place in children being screened for sepsis and/or having biobanking completed (a single blood sample) at two large tertiary sites. The surveys will be distributed to one of the child’s parents/caregiver’s, nurse and doctor on presentation and will be completed during ED stay (observation session). Surveys will aim to be completed at time closest to triage and within 4-hrs from initial presentation. All eligible participants where prospective consent is obtained will be given a study-specific questionnaire containing up to seven questions where they will rate their level of concern, to which they agree or disagree with a statement or question using a 5 point likert scale followed by two free text questions requesting information on symptoms and symptoms most concerning. Both medical officer and nurse caring for the child will receive a study specific survey one for medical, one for nurses, containing six questions to complete. It is anticipated the questionnaire takes no longer then five minutes to complete over a single session. The questionnaire will be handed to the medical officer, nurse and parent by either a research nurse or initiated by the clinician caring for the child if outside research team hours.
To ensure consistent comparison, all surveys have the same basic design and content, with minor adaptions to reflect the participant role (parent vs nurse vs doctor).
Intervention code [1] 318229 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324633 0
Suspected or proven infection in presence of organ dysfunction, defined as a pSOFA score >0 at time of assessment will be determined through linkage with medical records and pathology reports. A linear mixed effects model will be performed to assess the associations between the questionnaires assessing concern and the primary outcome.
Timepoint [1] 324633 0
Primary timepoint 1 for pSOFA score calculation will be determined at time closet to survey completion.
Secondary outcome [1] 385285 0
Suspected or proven infection and development of organ dysfunction, defined as a pSOFA score >0, within 48hours of presentation will be determined based on the review of organ dsyfunction through linkage with medical records and pathology reports. A linear mixed effects model will be performed to assess the associations between the questionnaire assessing concern and the secondary outcomes.


Timepoint [1] 385285 0
Within 48 hours from initial presentation
Secondary outcome [2] 388314 0
Confirmed or probable bacterial infection independent of organ dysfunction, within 48 hours of presentation determined through linkage with medical records and pathology reports.
Timepoint [2] 388314 0
Within 48 hours from initial presentation
Secondary outcome [3] 389485 0
Inter-rater reliability will be conducted and reported on for each rater (doctor, nurse & parent) against the primary and secondary outcomes
Timepoint [3] 389485 0
At time of survey completion

Eligibility
Key inclusion criteria
Child aged >30 days and <18 years old, presenting to the emergency department evaluated for sepsis on the sepsis pathway and/or having blood culture sampling, survey will aim to be completed at time closest to triage and within 4 hours from initial presentation, must be within ED stay, parent/caregiver and/or treating doctor and/or nurse available for survey.
Minimum age
30 Days
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parents who speak languages other than English, children with high suspicion of SARS-CoV-2, patients in clinical areas outside the ED such as ward or Paediatric Intensive Care Unit

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive analysis of demographics and baseline patient features of children which have had surveys completed
Exploratory factor analysis
Linear mixed effects model
Regression analysis
Qualitative data will be analysed using the Framework Method

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/12/2018
Date of last participant enrolment
Anticipated
1/02/2021
Actual
20/10/2020
Date of last data collection
Anticipated
1/02/2021
Actual
27/11/2020
Sample size
Target
400
Accrual to date
Final
533
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17192 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 17193 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 30897 0
4101 - South Brisbane
Recruitment postcode(s) [2] 30898 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 306357 0
Charities/Societies/Foundations
Name [1] 306357 0
Emergency Medicine Foundation (EMF)
Country [1] 306357 0
Australia
Primary sponsor type
University
Name
University of Qld
Address
St Lucia, QLD. 4072
Country
Australia
Secondary sponsor category [1] 307624 0
None
Name [1] 307624 0
Address [1] 307624 0
Country [1] 307624 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306565 0
Childrens Health Queensland Human Research Ethics Comittee
Ethics committee address [1] 306565 0
Ethics committee country [1] 306565 0
Australia
Date submitted for ethics approval [1] 306565 0
03/06/2017
Approval date [1] 306565 0
25/11/2017
Ethics approval number [1] 306565 0
HREC/17/QRCH/85, Amendment: 03

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

Contacts
Principal investigator
Name 104302 0
Ms Amanda Harley
Address 104302 0
501 Stanley St, South Brisbane QLD 4101
Paediatric Critical Care Research Group, Centre for Children's Health Research
Country 104302 0
Australia
Phone 104302 0
+61 417626323
Fax 104302 0
Email 104302 0
[email protected]
Contact person for public queries
Name 104303 0
Amanda Harley
Address 104303 0
501 Stanley St, South Brisbane QLD 4101
Paediatric Critical Care Research Group, Centre for Children's Health Research
Country 104303 0
Australia
Phone 104303 0
+61 417626323
Fax 104303 0
Email 104303 0
[email protected]
Contact person for scientific queries
Name 104304 0
Amanda Harley
Address 104304 0
501 Stanley St, South Brisbane QLD 4101
Paediatric Critical Care Research Group, Centre for Children's Health Research
Country 104304 0
Australia
Phone 104304 0
+61 417626323
Fax 104304 0
Email 104304 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
Will re-assess upon study completion


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10025Ethical approvalWithin published manuscript [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImpact of parental and healthcare professional concern on the diagnosis of pediatric sepsis: a diagnostic accuracy study.2023https://dx.doi.org/10.3389/fped.2023.1140121
N.B. These documents automatically identified may not have been verified by the study sponsor.