Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000039583
Ethics application status
Approved
Date submitted
22/01/2006
Date registered
25/01/2006
Date last updated
25/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Baby, Infant and Toddler Transillumination Study
Scientific title
Does transillumination of veins in children under three improve success rates of intravenous insertion?: a randomised controlled trial.
Secondary ID [1] 233 0
Auckland District Health Board: A+3417
Universal Trial Number (UTN)
Trial acronym
BITTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Any child under three who requires an intravenous leur. 1001 0
Condition category
Condition code
Other 1077 1077 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One group will have a transilluminator device that will be allowed to be switched on. The other group will start the same but then not be able to switch on the light. Either group may discard the device if they feel it is not helpful at this stage (e.g. they cannot find veins with or without the device,they feel the device is getting in the way). Duration of intervention is the duration the child is in the treatment room having the IV attempts (less than 30 minutes usually).
Intervention code [1] 853 0
Treatment: Devices
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1442 0
Success on inserting the intravenous luer on first attempt
Timepoint [1] 1442 0
Secondary outcome [1] 2552 0
Reduction in the number of children requiring three or more IV attempts while in the childrens emergency department. Children who would not qualify for this outcome would be those that leave the department to obtain IV access after less than 3 attempts or those children in whom IV access was not obtained but then deemed not necessary (usually pending blood results).
Timepoint [1] 2552 0

Eligibility
Key inclusion criteria
Requires an intravenous luer and is less than age three
Minimum age
Not stated
Maximum age
3 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Printed on back of an audit form
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Equal number of marked forms randomly sorted and sequentially selected from a pile.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The doctor in the treatment group can use the transillumination device how and when they would prefer (including deciding that it is not being helpful).
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
196
Accrual to date
Final
Recruitment outside Australia
Country [1] 262 0
New Zealand
State/province [1] 262 0

Funding & Sponsors
Funding source category [1] 1179 0
Government body
Name [1] 1179 0
Auckland District Health Board
Country [1] 1179 0
New Zealand
Funding source category [2] 1180 0
Other
Name [2] 1180 0
Joan Mary Reynolds research felowship
Country [2] 1180 0
Primary sponsor type
Government body
Name
Auckland District Health Board
Address
Country
New Zealand
Secondary sponsor category [1] 1039 0
University
Name [1] 1039 0
University of Auckland
Address [1] 1039 0
Country [1] 1039 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2496 0
Northern Y ethics committee
Ethics committee address [1] 2496 0
Ethics committee country [1] 2496 0
New Zealand
Date submitted for ethics approval [1] 2496 0
Approval date [1] 2496 0
Ethics approval number [1] 2496 0

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

Contacts
Principal investigator
Name 35190 0
Address 35190 0
Country 35190 0
Phone 35190 0
Fax 35190 0
Email 35190 0
Contact person for public queries
Name 10042 0
Dr David Herd
Address 10042 0
c/- Childrens Emergency Department
Starship Hospital
PO Box 92024
Auckland
Country 10042 0
New Zealand
Phone 10042 0
+64 021412732
Fax 10042 0
Email 10042 0
[email protected]
Contact person for scientific queries
Name 970 0
David Herd
Address 970 0
54 Woodside Ave
Northcote Auckland
Country 970 0
New Zealand
Phone 970 0
+64 6494805712
Fax 970 0
Email 970 0
[email protected]

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.