Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000005752
Ethics application status
Approved
Date submitted
10/10/2021
Date registered
11/01/2022
Date last updated
11/01/2022
Date data sharing statement initially provided
11/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
CATCH IT: The effect of bladder ultrasound on the time to collect a clean catch urine sample in the non-toilet trained child: a randomized control trial
Scientific title
CATCH IT: The effect of bladder ultrasound on the time to collect a clean catch urine sample in the non-toilet trained child: a randomized control trial
Secondary ID [1] 305505 0
None
Universal Trial Number (UTN)
Trial acronym
CATCH-IT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Emergency Medicine 323896 0
Urinary Tract Infection (UTI) 323897 0
Condition category
Condition code
Emergency medicine 321410 321410 0 0
Other emergency care
Renal and Urogenital 321658 321658 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The use of Point-Of-Care Ultrasound (POCUS) bladder scan, and whether it reduces the time taken to collect a clean catch urine from a non-toilet trained child.

As per the control arm, parents/carers were provided with the same written information on how to collect a CCU sample. The child was prepared for collection in the same fashion as the control arm (nappy/underwear removed, and genitals gently cleaned with cotton wool and water). A urine sample pot was provided at the same time as the bladder scan, and parents/carers advised to be ready for collection of urine. Starting time was recorded at the beginning of the ultrasound.
The Sonosite X-Porte ultrasound machine was used (with room temperature gel pre-applied) to calculate bladder volume via the in-built ‘Bladder Volume’ function. If the bladder volume was over 7ml/kg, then the parents/carers were informed that micturition is imminent and advised to be on high alert for collection. If no urine was passed in 30 minutes, then the bladder scan was repeated. If there was minimal increase in volume, then parents/carers were encouraged to increase oral fluid administration. Conversely, if the repeat scan showed a volume of over 7ml/kg, the parents/carers were advised to be vigilant due to impending micturition. All ultrasounds were either performed or directly supervised by one of the authors (RL) who is accredited for the Extended Focused Abdominal Scan in Trauma (EFAST) with the Australasian College for Emergency Medicine (ACEM).
Intervention code [1] 321907 0
Diagnosis / Prognosis
Intervention code [2] 322100 0
Treatment: Devices
Comparator / control treatment
Traditional 'watch and wait' method of collecting a clean catch urine sample from a non-toilet trained child.

The patients’ parents/carers were provided with written information on how to collect a CCU sample. The patient was prepared for a CCU sample by removing nappy/underwear, and cleaning of genitals with cotton wool and water. A sterile urine sample pot was provided, and time recorded as soon as the nappy was undone and the urine pot provided. Time of sample collection and number of attempts required were also recorded.
Control group
Active

Outcomes
Primary outcome [1] 329185 0
Time taken to collect a clean catch urine sample.

This was recorded as two time stamps, firstly when parents/caregivers were provided with the urine pot/bladder scan, and second time stamp when parents/caregivers alerted medical staff to successful clean catch urine.
Timepoint [1] 329185 0
From time of setting parents/caregivers up with sterile pot for clean catch urine, till collection of clean catch urine by parents/caregivers
Secondary outcome [1] 401728 0
Frequency of missed collections, assessed by parents/caregivers self reporting of missed collection.

This will be assessed by direct parent/caregiver interview, as well as medical record review
Timepoint [1] 401728 0
Parents/caregivers will be required to report every missed collection, from provision of sterile pot, to collection of clean catch urine, or till discharge

Eligibility
Key inclusion criteria
0-36 months of age child
Non-toilet trained
Requiring a clean catch urine for assessment
Minimum age
0 Months
Maximum age
36 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Toilet trained children
Any child requiring an alternative form of collection due to clinical concern (e.g. unwell child requiring transurethral catheterisation or supra-pubic aspirate)

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)
Sealed opaque study envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random sequencing via Microsoft Excel's Random Number Generator
This was used to make sequential study packs, assigned in sequential order of patient recruitment
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
11/01/2017
Date of last participant enrolment
Anticipated
Actual
24/11/2019
Date of last data collection
Anticipated
Actual
24/11/2019
Sample size
Target
100
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20709 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 35511 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 309866 0
Government body
Name [1] 309866 0
Northern Sydney Local Health District
Country [1] 309866 0
Australia
Primary sponsor type
Hospital
Name
Paediatric Emergency Department, Royal North Shore Hospital
Address
Paediatric Emergency Department, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Country
Australia
Secondary sponsor category [1] 310903 0
None
Name [1] 310903 0
Address [1] 310903 0
Country [1] 310903 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309602 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 309602 0
Ethics committee country [1] 309602 0
Australia
Date submitted for ethics approval [1] 309602 0
Approval date [1] 309602 0
01/01/2017
Ethics approval number [1] 309602 0

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

Contacts
Principal investigator
Name 114730 0
Dr Richard Lennon
Address 114730 0
Paediatric Emergency Department, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Country 114730 0
Australia
Phone 114730 0
+61 401 719 524
Fax 114730 0
Email 114730 0
[email protected]
Contact person for public queries
Name 114731 0
Richard Lennon
Address 114731 0
Paediatric Emergency Department, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Country 114731 0
Australia
Phone 114731 0
+61 2 9463 2222
Fax 114731 0
Email 114731 0
[email protected]
Contact person for scientific queries
Name 114732 0
Richard Lennon
Address 114732 0
Paediatric Emergency Department, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Country 114732 0
Australia
Phone 114732 0
+61 2 9463 2222
Fax 114732 0
Email 114732 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.