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
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
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?
Secondary ID [1] 282863 0
Nil
Universal Trial Number (UTN)
U1111-1145-8244
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Constipation versus non-defecation 289676 0
Condition category
Condition code
Oral and Gastrointestinal 289993 289993 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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We are describing the normal bowel function in critically unwell children, which is currently unpublished.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.
Intervention code [1] 287559 0
Not applicable
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.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290043 0
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.
Timepoint [1] 290043 0
Per Day of ICU stay
Secondary outcome [1] 303828 0
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.
Timepoint [1] 303828 0
Per bowel motion during hospital stay
Secondary outcome [2] 303829 0
Length of Hospital stay
Timepoint [2] 303829 0
Total Hospital duration until discharge

Eligibility
Key inclusion criteria
All children admitted to our Intensive Care Unit
Minimum age
No limit
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adults, or being managed by an Adult Specialty team.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
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.

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)
QLD
Recruitment hospital [1] 1347 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 7180 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 287642 0
Self funded/Unfunded
Name [1] 287642 0
Address [1] 287642 0
Country [1] 287642 0
Primary sponsor type
Individual
Name
Dr Smalley
Address
Townsville Hospital
100 Angus Smith Drive
Douglas, QLD 4814
Country
Australia
Secondary sponsor category [1] 286383 0
None
Name [1] 286383 0
Address [1] 286383 0
Country [1] 286383 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289612 0
Townsville Hospital Health Service Human Research Ethics Committee
Ethics committee address [1] 289612 0
Townsville Hospital
100 Angus Smith Drive
Douglas, QLD 4814
Ethics committee country [1] 289612 0
Australia
Date submitted for ethics approval [1] 289612 0
19/07/2013
Approval date [1] 289612 0
09/08/2013
Ethics approval number [1] 289612 0
HREC/13/QTHS/132

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41566 0
Dr Nathan Smalley
Address 41566 0
Townsville Hospital
100 Angus Smith Drive
Douglas, QLD 4814
Country 41566 0
Australia
Phone 41566 0
+61 7 4433 1111
Fax 41566 0
Email 41566 0
nathan_smalley@health.qld.gov.au
Contact person for public queries
Name 41567 0
Dr Nathan Smalley
Address 41567 0
Townsville Hospital
100 Angus Smith Drive
Douglas, QLD 4814
Country 41567 0
Australia
Phone 41567 0
+61 7 4433 1111
Fax 41567 0
Email 41567 0
nathan_smalley@health.qld.gov.au
Contact person for scientific queries
Name 41568 0
Dr Nathan Smalley
Address 41568 0
Townsville Hospital
100 Angus Smith Drive
Douglas, QLD 4814
Country 41568 0
Australia
Phone 41568 0
+61 7 4433 1111
Fax 41568 0
Email 41568 0
nathan_smalley@health.qld.gov.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