The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Address [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
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary