Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000737639
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
11/11/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
TREATMENT OF PRIMARY ASPIRATION IN CHILDREN: A RANDOMISED CONTROLLED TRIAL TO DETERMINE EFFECTS OF UNLIMITED ORAL INTAKE OF WATER IN CHILDREN WITH DOCUMENTED ASPIRATION ON THIN FLUIDS.
Scientific title
TREATMENT OF PRIMARY ASPIRATION IN CHILDREN: A RANDOMISED CONTROLLED TRIAL TO DETERMINE EFFECTS OF UNLIMITED ORAL INTAKE OF WATER IN CHILDREN WITH DOCUMENTED ASPIRATION ON THIN FLUIDS.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary aspiration of thin fluids in children 889 0
Condition category
Condition code
Respiratory 957 957 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Unrestricted oral water intake (with thickened fluids)
Intervention code [1] 592 0
None
Comparator / control treatment
Full thin fluid restriction (with thickened fluids)
Control group
Active

Outcomes
Primary outcome [1] 1257 0
Number of respiratory episodes
Timepoint [1] 1257 0
For 12 months following the child's modified barium swallow study.
Secondary outcome [1] 2292 0
CARIFS score
Timepoint [1] 2292 0
Over 12 months
Secondary outcome [2] 2293 0
Fluid intake
Timepoint [2] 2293 0

Eligibility
Key inclusion criteria
All infants and children undergoing a modified barium swallow study at RCH, Brisbane.
Minimum age
Not stated
Maximum age
18 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)
A list of sequential numbers with treatment allocations concealed by black stickers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation and sequence generation in blocks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/03/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1055 0
Hospital
Name [1] 1055 0
Royal Children's Hospital Foundation, RCH Brisbane
Country [1] 1055 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital
Address
Country
Australia
Secondary sponsor category [1] 916 0
Individual
Name [1] 916 0
Kelly Weir
Address [1] 916 0
Country [1] 916 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2354 0
Royal Children's Hospital
Ethics committee address [1] 2354 0
Brisbane
Ethics committee country [1] 2354 0
Australia
Date submitted for ethics approval [1] 2354 0
Approval date [1] 2354 0
Ethics approval number [1] 2354 0

Summary
Brief summary
Following detection of primary aspiration of thin fluids on MBS, participants are randomly assigned to a treatment group of restricted oral water intake (with thickened fluids) or unrestricted oral intake of water.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35161 0
Address 35161 0
Country 35161 0
Phone 35161 0
Fax 35161 0
Email 35161 0
Contact person for public queries
Name 9781 0
Kelly Weir
Address 9781 0
Department of Paediatrics and Child Health
Royal Children's Hospital
Level 3 Royal Children's Hospital Foundation Building
Herston Rd
Herston QLD 4029
Country 9781 0
Australia
Phone 9781 0
+61 7 33655268
Fax 9781 0
+61 7 33655455
Email 9781 0
k.weir1@uq.edu.au
Contact person for scientific queries
Name 709 0
Kelly Weir
Address 709 0
Department of Paediatrics and Child Health
Royal Children's Hospital
Level 3 Royal Children's Hospital Foundation Building
Herston Rd
Herston QLD 4029
Country 709 0
Australia
Phone 709 0
+61 7 33655268
Fax 709 0
+61 7 33655455
Email 709 0
k.weir1@uq.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.