Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000502639
Ethics application status
Approved
Date submitted
23/09/2005
Date registered
23/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ultrasound Study
Scientific title
Ultrasound examination of Extensive Limb Swelling Reactions following DTPa or dTpa immunisation in preschool children
Secondary ID [1] 180 0
REC 1428/02/06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extensive Swelling Reactions following diphtheria-tetanus-acellular pertussis immunisation 627 0
Condition category
Condition code
Respiratory 699 699 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Descriptive study to assess extensive swelling reactions clinically and using ultrasound to identify tissue involvement. Initial ultrasound examination and follow-up ultrasound 48 -96 hours later.
Intervention code [1] 669 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 851 0
A description of the tissues involved and extent of tissue swelling following DTPa immunisation.
Timepoint [1] 851 0
Ultrasound measure taken at 24 hours and 48-96 hours post first examination.
Secondary outcome [1] 1692 0
To assess ultrasound as an aid to more accurate measurement of extensive limb swelling reactions.
Timepoint [1] 1692 0

Eligibility
Key inclusion criteria
Free of health problems;- extensive limb swelling reactions as defined by swelling >50mms in size or 30% increase in upper limb swelling circumference follwoing DTPa or dTpa vaccination.
Minimum age
4 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Chronic administration of immunosuppresants or antiinflammatories 2 weeks prior to enrolment.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 774 0
Self funded/Unfunded
Name [1] 774 0
Country [1] 774 0
Primary sponsor type
Hospital
Name
Women's and Children's Hospital (part of Children, Youth and Women's Health Service)
Address
Country
Australia
Secondary sponsor category [1] 636 0
None
Name [1] 636 0
Nil
Address [1] 636 0
Country [1] 636 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2019 0
Women's and Children's Hospital
Ethics committee address [1] 2019 0
Ethics committee country [1] 2019 0
Australia
Date submitted for ethics approval [1] 2019 0
Approval date [1] 2019 0
Ethics approval number [1] 2019 0

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

Contacts
Principal investigator
Name 35123 0
Address 35123 0
Country 35123 0
Phone 35123 0
Fax 35123 0
Email 35123 0
Contact person for public queries
Name 9858 0
Dr Helen Marshall
Address 9858 0
University Department of Paediatrics
Women's and Children's Hospital
72 King William Road
North Adelaide SA 5006
Country 9858 0
Australia
Phone 9858 0
+61 8 81618115
Fax 9858 0
+61 8 81617031
Email 9858 0
helen.marshall@adelaide.edu.au
Contact person for scientific queries
Name 786 0
Dr Helen Marshall
Address 786 0
University Department of Paediatrics
Women's and Children's Hospital
72 King William Road
North Adelaide SA 5006
Country 786 0
Australia
Phone 786 0
+61 8 81618115
Fax 786 0
+61 8 81617031
Email 786 0
helen.marshall@adelaide.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.