Trial Review

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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
ACTRN12608000146392
Ethics application status
Not yet submitted
Date submitted
20/03/2008
Date registered
27/03/2008
Date last updated
27/03/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Using real time ultrasound to assit with urine collection
Scientific title
In children under 2 years of age or less with possible urinary tract infection (UTI) is real time ultrasound better than bladder scanner for assisting collection of a clean urine specimen
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary tract infection 2950 0
Condition category
Condition code
Infection 3089 3089 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Real time ultrasound guided supra pubic aspiration of urine. This involves using an ultrasound machine to visualise and guide the needle passing through the tissues and into the bladder
Intervention code [1] 2682 0
Other interventions
Comparator / control treatment
Bladder scanner to identify >15 mls of urine and blind supra pubic aspitate (SPA). This involves using the bladder scanner by scanning at the lower abdominal crease to gain a measure of bladder urine volume prior to blind passing of the needle through the abdominal wall into the bladder
Control group
Active

Outcomes
Primary outcome [1] 3976 0
Success rate, measured as obtaining >0.2 mls of urine for microscopy and culture
Timepoint [1] 3976 0
At time of procedure
Primary outcome [2] 3977 0
Number of attempts to success
Timepoint [2] 3977 0
At time of procedure
Secondary outcome [1] 6690 0
Parental satisfaction, using a standard 5 point Likert scale
Timepoint [1] 6690 0
At time of procedure

Eligibility
Key inclusion criteria
<2 years old
Needing clean urine sample
Minimum age
0 Years
Maximum age
2 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
age of 2 years or more
Bladder pathology or presence of cystostomy, that makes insertion of a catheter more appropriate.
Parent s non-English speaking and no interpreter available.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3205 0
Hospital
Name [1] 3205 0
Royal Children's Hospital Melbourne
Country [1] 3205 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital
Address
Flemington Rd
Parkville
Vic 3052
Country
Australia
Secondary sponsor category [1] 2873 0
None
Name [1] 2873 0
Address [1] 2873 0
Country [1] 2873 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5185 0
Ethics committee address [1] 5185 0
Ethics committee country [1] 5185 0
Date submitted for ethics approval [1] 5185 0
01/04/2008
Approval date [1] 5185 0
Ethics approval number [1] 5185 0

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

Contacts
Principal investigator
Name 28455 0
Address 28455 0
Country 28455 0
Phone 28455 0
Fax 28455 0
Email 28455 0
Contact person for public queries
Name 11612 0
Ed Oakley
Address 11612 0
Department of EmergencyMedicine
Royal Children's Hospital
Flemington Rd
Parkville
Vic 3052
Country 11612 0
Australia
Phone 11612 0
(03) 9345 6592
Fax 11612 0
Email 11612 0
ed.oakley@rch.org.au
Contact person for scientific queries
Name 2540 0
Ed oakley
Address 2540 0
Department of EmergencyMedicine
Royal Children's Hospital
Flemington Rd
Parkville
Vic 3052
Country 2540 0
Australia
Phone 2540 0
(03)93456592
Fax 2540 0
Email 2540 0
ed.oakley@rch.org.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.