Urinary Tract InfectionNCT00368888
Clinical Study of New Urine Collection Bag for Infants.
A study testing Urine collection bag for infants in people with Urinary Tract Infection, run by Bergaliden Barnavårdscentral at 1 site in Sweden.
Trial summary
To determine whether a new urine collection bag for infants produces a reliable urine sample for culturing in respect of contamination rate with skin bacteria. Read more about this study
- Who is it for?
- Ages 0 to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Urine collection bag for infants
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteSweden
- Study dates
- Mar 2004to Sep 2006
- 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 0 to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children.
Who cannot join
- Current infection of any kind. History of urinary tract infection.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Bergaliden Barnavårdscentral (Child Care Center)
Helsingborg, 251 87
About this study
To determine whether a new urine collection bag for infants produces a reliable urine sample for culturing in respect of contamination rate with skin bacteria.
- Conditions
- Urinary Tract Infection
- Being tested
- Urine collection bag for infants
- 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.
Urine collection bag for infantsDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startMar 2004
- Study completionSep 2006
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Bergaliden Barnavårdscentral
- Sponsor type
- University, hospital or other
- Investigators
- Markus Perlhagen, Doctor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368888
- Sponsor's protocol ID
- LIVI4099
- Status last verified
- Sep 2006
- First submitted
- 28 Aug 2006
- Last updated
- 12 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of New Urine Collection Bag for Infants.
- ClinicalTrials.gov ID
- NCT00368888
- Acronym / sponsor ID
- LIVI4099
- Conditions
- Urinary Tract Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bergaliden BarnavårdscentralUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Sep 2006
- First posted
- 29 Aug 2006 (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.
To determine whether a new urine collection bag for infants produces a reliable urine sample for culturing in respect of contamination rate with skin bacteria.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children.
Key exclusion criteria (1 listed)
- Current infection of any kind. History of urinary tract infection.
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 |
|---|---|---|
| Urine collection bag for infants | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2006.
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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.
Markus Perlhagen, Doctor principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine collection bag for infants in people with Urinary Tract Infection, run by Bergaliden Barnavårdscentral at 1 site in Sweden.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Sep 2006. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 12 Sep 2006.