Urinary Tract Infection0244-12-RMCNCT01895465
Improvement in Urine Collection Methods in Children
A study testing Slitted diaper in people with Urinary Tract Infection and Unspecified Fever, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The population of children presenting to the Emergency Department (ED) for treatment increases day by day, creating a further burden on the limited nursing staff and where many children and their parents are forced to wait many hours until their medical investigation ends. Read more about this study
- Who is it for?
- Ages 1 month to 14 years
- Conditions the study is for
- Urinary Tract Infection, Unspecified Fever
- What is being tested?
- Slitted diaper
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children incapable of giving urine voluntarily in the Emergency Department
- Children requiring an urine test
- Children whose parents have agreed to take part in the research and have signed a consent form
Who cannot join
- Children who have an immediate medical condition which requires catheterization
- Parents who have declined taking part in the research
- Children who give urine voluntarily
- Children who do not need an urine test for their continued treatment
Trial locations and contacts
1 site in 1 country.
Israel1 site
Schneider Children's Medical Center of Israel
Petah Tikva, 49202
Yehezkel Waisman, Prof., 972-3-9253661, waisy@clalit.org.il
Yehezkel Waisman, Prof.
About this study
The population of children presenting to the Emergency Department (ED) for treatment increases day by day, creating a further burden on the limited nursing staff and where many children and their parents are forced to wait many hours until their medical investigation ends. Part of the many hours waited are for various tests the patient has to undergo, where the urine test is one of the main ones.
Urinary tract infections in children are a common cause of death due to acute and chronic complications alike. Our study aims to test a urine collection method to see whether it reduces parents' and/or nursing staff's involvement and thereby reducing the urine sample's percentage of contamination.
Read the detailed description
The study intends to explore whether on obtaining a pediatric urine sample by using a diaper in an innovative way can shorten the waiting time parents have to endure until an urine sample is perceived, and accordingly, the percentage of contamination in the samples obtained. The innovativeness introduced is that by using an ordinary everyday diaper, which is found in all marketing outlets, and by making a slit in the diaper where the pediatric urine collecting bag can be pulled out and thus allowing parents/care takers to see straight away whether urine has been given and thus cut back on opening and reopening of the diaper.
- Conditions
- Urinary Tract Infection, Unspecified Fever
- Being tested
- Slitted diaper
- Keywords
- urine collection, contamination
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slitted diaperDevice
Also called Huggies, Pampers, etc.
A diaper where a slit is made through which a urine collection bag is pulled through
| Study group | Role | What they receive |
|---|---|---|
| A slitted diaper | Experimental | An ordinary pediatric urine collection bag used in the ED that will be used together with the slitted diaper Receives: Device: Slitted diaper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recording of time elapsed between physician's request for an urine test to be taken until obtained
Measured: 12 months
Secondary outcomes (1)
Percentage of contamination in urine cultures obtained
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, waisman yehezkel, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895465
- Sponsor's protocol ID
- SCHNEIDER/7329
- Acronym
- 0244-12-RMC
- Status last verified
- Jul 2013
- First submitted
- 4 Jul 2013
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Urine Collection Methods in Children
- ClinicalTrials.gov ID
- NCT01895465
- Acronym / sponsor ID
- 0244-12-RMC / SCHNEIDER/7329
- Conditions
- Urinary Tract Infection, Unspecified Fever
- Keywords
- urine collection, contamination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The population of children presenting to the Emergency Department (ED) for treatment increases day by day, creating a further burden on the limited nursing staff and where many children and their parents are forced to wait many hours until their medical investigation ends. Part of the many hours waited are for various tests the patient has to undergo, where the urine test is one of the main ones.
Urinary tract infections in children are a common cause of death due to acute and chronic complications alike. Our study aims to test a urine collection method to see whether it reduces parents' and/or nursing staff's involvement and thereby reducing the urine sample's percentage of contamination.
Detailed description
The study intends to explore whether on obtaining a pediatric urine sample by using a diaper in an innovative way can shorten the waiting time parents have to endure until an urine sample is perceived, and accordingly, the percentage of contamination in the samples obtained. The innovativeness introduced is that by using an ordinary everyday diaper, which is found in all marketing outlets, and by making a slit in the diaper where the pediatric urine collecting bag can be pulled out and thus allowing parents/care takers to see straight away whether urine has been given and thus cut back on opening and reopening of the diaper.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A slitted diaper | Experimental | Device: Slitted diaperAn ordinary pediatric urine collection bag used in the ED that will be used together with the slitted diaper |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children incapable of giving urine voluntarily in the Emergency Department
- Children requiring an urine test
- Children whose parents have agreed to take part in the research and have signed a consent form
Key exclusion criteria (4 listed)
- Children who have an immediate medical condition which requires catheterization
- Parents who have declined taking part in the research
- Children who give urine voluntarily
- Children who do not need an urine test for their continued treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slitted diaperAlso: Huggies, Pampers, etc.A diaper where a slit is made through which a urine collection bag is pulled through | Device | A slitted diaper |
Primary outcome
Recording of time elapsed between physician's request for an urine test to be taken until obtained
Time frame: 12 months
1 secondary outcome
Percentage of contamination in urine cultures obtained
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slitted diaper in people with Urinary Tract Infection and Unspecified Fever, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recording of time elapsed between physician's request for an urine test to be taken until obtained (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2013.