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Trial registered on ANZCTR
Registration number
ACTRN12613000810718
Ethics application status
Approved
Date submitted
19/07/2013
Date registered
24/07/2013
Date last updated
31/03/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
Assessing normal bowel function and impact of bowel care medications in children in an intensive care setting
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Scientific title
Prospective cohort pilot study of severely unwell children admitted to ICU, in relation to their normal bowel function and our application of the statewide bowel care protocol, assessing the effect on symptomatology and length of stay. Is a future non-interventional trial required?
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Secondary ID [1]
282863
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Nil
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Universal Trial Number (UTN)
U1111-1145-8244
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Constipation versus non-defecation
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Condition category
Condition code
Oral and Gastrointestinal
289993
289993
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0
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Normal oral and gastrointestinal development and function
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
We are describing the normal bowel function in critically unwell children, which is currently unpublished. We are applying standard care using the Queensland Health PICU Bowel Care protocol. The duration of observation is from the patient's intensive care admission until hospital discharge.
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Intervention code [1]
287559
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Not applicable
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Comparator / control treatment
There is no control group- all participants receive care according to the usual protocol for the unit. No-one will receive non-standard care.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Number of bowel motion events per day in Intensive Care, counted by the bedside nurse, recording also the consistency of each motion using the Bristol Stool Chart Scale.
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Assessment method [1]
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Timepoint [1]
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Per Day of ICU stay
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Secondary outcome [1]
303828
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Bowel motion effects of protocolised care. This includes altered consistency/number of motions as scored on the Bristol Stool Chart Scale and counted by the bedside nurse, as well as other side effects such as presence of perianal excoriation.
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Assessment method [1]
303828
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Timepoint [1]
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Per bowel motion during hospital stay
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Secondary outcome [2]
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Length of Hospital stay
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Assessment method [2]
303829
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Timepoint [2]
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Total Hospital duration until discharge
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Eligibility
Key inclusion criteria
All children admitted to our Intensive Care Unit
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Minimum age
No limit
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Maximum age
16
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Adults, or being managed by an Adult Specialty team.
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
This is a pilot study in an un-researched field, so we used recent adult ICU literature which used a cohort of 44 patients. We have selected 100 patients, which is approx 6 months worth of admissions.
We will then use the Dept of Biostatistics at James Cook University to assist with analysis.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
2/09/2013
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Actual
14/08/2013
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Date of last participant enrolment
Anticipated
3/03/2014
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Actual
19/03/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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The Townsville Hospital - Douglas
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Recruitment postcode(s) [1]
7180
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4814 - Douglas
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
287642
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Country [1]
287642
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Primary sponsor type
Individual
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Name
Dr Smalley
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Address
Townsville Hospital
100 Angus Smith Drive
Douglas, QLD 4814
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
286383
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Address [1]
286383
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Country [1]
286383
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Townsville Hospital Health Service Human Research Ethics Committee
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Ethics committee address [1]
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Townsville Hospital
100 Angus Smith Drive
Douglas, QLD 4814
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
289612
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19/07/2013
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Approval date [1]
289612
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09/08/2013
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Ethics approval number [1]
289612
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HREC/13/QTHS/132
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Summary
Brief summary
Aims:
We would like to describe what the normal bowel function is in severely unwell children who are managed in our intensive care unit. Our current management protocol is based on that from the Royal Children's Hospital, Brisbane, and we want to investigate the effectiveness, or not, of this protocol in our population. We hypothesise that it is normal for the gut to behave differently when unwell compared to in good health, and that management strategies may lead to over-treatment and potential longer hospital stay. This is previously unpublished in children's intensive care literature.
Research design:
This is a prospective, observational study involving no deviation from current treatment received in our unit. This is a pilot study, which may lead on to a larger multi-centre trial to be run by a larger research group, such as ANZICS CTG, which would investigate the effect of non-intervention in those with slower bowel function, rather than escalating intervention.
Methods:
We will approach all admissions to our unit to be enrolled in this study. Participation will involve no change to management, only completion of the study questionnaire by the researcher every day until hospital discharge. Results will then be analysed prior to publication.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Nathan Smalley
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Address
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Townsville Hospital
100 Angus Smith Drive
Douglas, QLD 4814
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Country
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Australia
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Phone
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+61 7 4433 1111
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Nathan Smalley
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Address
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Townsville Hospital
100 Angus Smith Drive
Douglas, QLD 4814
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Country
41567
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Australia
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Phone
41567
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+61 7 4433 1111
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Fax
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Email
41567
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[email protected]
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Contact person for scientific queries
Name
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Dr Nathan Smalley
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Address
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Townsville Hospital
100 Angus Smith Drive
Douglas, QLD 4814
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Country
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Australia
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Phone
41568
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+61 7 4433 1111
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Fax
41568
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Email
41568
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[email protected]
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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.
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