Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000754549
Ethics application status
Approved
Date submitted
3/06/2015
Date registered
21/07/2015
Date last updated
16/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Can gentle cutaneous stimulation with cold fluid soaked gauze hasten Clean Catch Collection of Urine in infants?
Scientific title
Can gentle cutaneous stimulation with cold fluid soaked gauze hasten Clean Catch Collection of Urine in infants, compared to routine genital cleaning alone?
Secondary ID [1] 286851 0
Nil
Universal Trial Number (UTN)
nil
Trial acronym
Quick-Wee: U3C in ED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urine sample collection in infants
 295244 0
Condition category
Condition code
Renal and Urogenital 295490 295490 0 0
Other renal and urogenital disorders
Public Health 295629 295629 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
If randomized to intervention arm, after routine genital cleaning the clinician (or parent/carer with supervision) rubs the suprapubic area of child with cold fluid soaked gauze (normal saline refrigerated at 2.8 degrees celcius) held by disposable plastic forceps in a circular pattern, for up to 5 minutes.
Intervention code [1] 292018 0
Diagnosis / Prognosis
Comparator / control treatment
Routine cleaning of the genital area before commencing CCU attempt.
Control group
Active

Outcomes
Primary outcome [1] 295223 0
Primary outcome measure: voiding urine within 5 minutes
Timepoint [1] 295223 0
Timepoint: binary yes/no outcome at 5 minutes
Secondary outcome [1] 315106 0
Secondary outcome 1:
Parental and clinician satisfaction with the urine collection technique in each group (1-5 satisfaction rating scale)
Timepoint [1] 315106 0
Timepoint: immediately after urine collection attempt
Secondary outcome [2] 315107 0
Secondary Outcome 2:
If the child voids, whether there is a successful CCU caught, or if the void is missed
Timepoint [2] 315107 0
Timepoint: immediately after urine collection attempt
Secondary outcome [3] 315108 0
Secondary outcome 3:
Contamination rate of CCU samples obtained within 5 minutes
(binary yes/no outcome: urine culture contamination as per hospital laboratory definition)
Timepoint [3] 315108 0
Timepoint: 48hours after specimen collection
Secondary outcome [4] 315109 0
We will also collect data relating to patient demographics, reason for presentation/urine collection, and clinical management after CCU attempt from the case record form and hospital records.
Timepoint [4] 315109 0
Before and 2 days after urine collection attempt

Eligibility
Key inclusion criteria
- Age 1-12 months
- Not able to void urine on request
- Require and be appropriate for CCU sample collection, as determined by the treating clinician in the Emergency Department
Minimum age
1 Months
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Children able to void on request to provide urine sample
- Children less than 1 month of age
- Children greater than 12 months of age
- Need for immediate urine sample via sterile method as determined by treating clinician
- Anatomical or neurological abnormality affecting voiding or sensation

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)
Nursing and/or medical staff will identify potentially suitable patients requiring urine sample collection, and make a decision about the appropriate method of urine sample collection on clinical grounds (independent of this research project), at the point of triage or during clinical assessment.

If appropriate for CCU and meeting inclusion criteria, a study researcher or clinician will invite the parents or carer of suitable patients to provide verbal consent to participate in the study.
Study participants will be randomly assigned, in a 1:1 ratio, to the intervention (additional suprapubic cutaneous stimulation with cold saline soaked gauze) or standard care, via opaque envelopes containing patient allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Study participants will be randomly assigned, in a 1:1 ratio, to the intervention (additional suprapubic cutaneous stimulation with cold saline soaked gauze) or standard care. A statistician not directly involved in the analysis of the study results will prepare the randomisation schedule using random permuted blocks with at least three different block sizes to ensure concealment of allocation. A paper based system using opaque envelopes will be used to allocate participants in the emergency department.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis will be by intention-to-treat, including all randomised participants where primary outcome data is available.

The primary outcome measure is a binary yes/no outcome of voiding urine within 5 minutes. We will report the absolute difference between the two groups for percentage of successful CCU, together with the 95% confidence interval for the difference of percentages, and calculate p values using a chi squared test.

Secondary outcome measures will be:
- parental and clinician satisfaction with the urine collection technique in each group
- whether there is a successful CCU caught in each group
- contamination rate of CCU samples in each group
For each secondary outcome, we will describe the rates of successful CCU and contamination for each group with percentages and 95% confidence intervals. The appropriate difference between groups will be estimated (difference of proportions for categorical outcomes, difference of means for continuous outcomes), together with the 95% confidence interval for the difference. P values will be estimated using chi square for categorical variables and t-test or Wilcoxon rank sum tests for continuous variables.

As a sensitivity analysis, all treatment comparisons for primary and secondary outcomes will also be presented adjusted for age and sex to account for any chance imbalance between the treatment groups with respect to this potentially confounding factor using linear and logistic regression models for continuous and binary outcomes respectively.

A sample size of 354 patients will be included for the study (177 in each group).

A Baseline Study was conducted where the time to void for children requiring CCU using standard urogenital cleaning alone was measured. 12/57 (21%) of patients <12 months of age voided in less than 5 minutes. We surveyed a panel of 20 expert clinicians (Paediatric Emergency Medicine Physicians and Paediatricians at consultant level) who reported a 15% increase in success rate would suggest that this simple technique should be incorporated into their clinical practice. Data from 40 patients in a completed Pilot Feasibility Study suggests this is a reasonable estimate of the likely treatment effect.

With a sample size of 322 patients (161 in each group) the study would have 80% power to detect a difference of 21% (non-intervention arm) vs 35% (intervention arm) success rate of infants voiding within 5 minutes. An additional 10% of patients (16 in each group) will be recruited in the sample size to account for a small percentage of loss to follow-up of primary outcome results.

Power calculations were completed using Stata: Estimated total sample size for a two-sample proportions test (Pearsons x2 test).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2015
Actual
10/08/2015
Date of last participant enrolment
Anticipated
31/12/2016
Actual
15/03/2016
Date of last data collection
Anticipated
Actual
17/03/2016
Sample size
Target
354
Accrual to date
Final
354
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3861 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 9759 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 291405 0
Charities/Societies/Foundations
Name [1] 291405 0
Shepherd Foundation
Country [1] 291405 0
Australia
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Flemington Rd, Parkville 3052 Melbourne, VIC, Australia
Country
Australia
Secondary sponsor category [1] 290080 0
Hospital
Name [1] 290080 0
Emergency Department, Royal Children's Hospital
Address [1] 290080 0
50 Flemington Rd, Parkville 3056
Country [1] 290080 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292953 0
Royal Children's Hospital, Melbourne
Ethics committee address [1] 292953 0
Ethics committee country [1] 292953 0
Australia
Date submitted for ethics approval [1] 292953 0
Approval date [1] 292953 0
29/04/2015
Ethics approval number [1] 292953 0
35083A

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

Contacts
Principal investigator
Name 57794 0
Dr Jonathan Kaufman
Address 57794 0
Emergency Department
Royal Children’s Hospital
52 Flemington Rd, Parkville 3052 VIC
Country 57794 0
Australia
Phone 57794 0
+613 9345 5522
Fax 57794 0
Email 57794 0
[email protected]
Contact person for public queries
Name 57795 0
Jonathan Kaufman
Address 57795 0
Emergency Department
Royal Children’s Hospital
52 Flemington Rd, Parkville 3052 VIC
Country 57795 0
Australia
Phone 57795 0
+613 9345 5522
Fax 57795 0
Email 57795 0
[email protected]
Contact person for scientific queries
Name 57796 0
Jonathan Kaufman
Address 57796 0
Emergency Department
Royal Children’s Hospital
52 Flemington Rd, Parkville 3052 VIC
Country 57796 0
Australia
Phone 57796 0
+613 9345 5522
Fax 57796 0
Email 57796 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
SourceTitleYear of PublicationDOI
EmbaseThe QuickWee trial: Protocol for a randomised controlled trial of gentle suprapubic cutaneous stimulation to hasten non-invasive urine collection from infants.2016https://dx.doi.org/10.1136/bmjopen-2016-011357
N.B. These documents automatically identified may not have been verified by the study sponsor.