Urinary Tract InfectionBLSTNCT02117102
Effect of Use of a New Technique for Pediatric Urine Collection in ER
A study testing Bladder and lumbar stimulation technic in people with Urinary Tract Infection and Unspecified Fever, run by Jeju National University Hospital at 1 site in South Korea.
Trial summary
Urinary tract infection is most common serious bacterial infection in children who admit into the emergency department (ED). However the collection of urine from young children is time consuming process. So many children and their family guardian waste time until medical disposition established. Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Urinary Tract Infection, Unspecified Fever
- What is being tested?
- Bladder and lumbar stimulation technic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Dec 2014
- 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 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children have unspecific fever and requiring and urine test
Who cannot join
- Initial shock state
- History of congenial urinary tract abnormality
- Parents who have declined taking part in the research
Trial locations and contacts
1 site in 1 country.
Jeong Ho Kang contact
South Korea1 site
Jeju national university hospital
Jeju City, Jeju Special Governing Province, 690 767
About this study
Official title: Effect of Use of a New Technique for Pediatric Urine Collection on the Length of Stay in the Emergency Department: Prospective Randomized Controlled Trial
Urinary tract infection is most common serious bacterial infection in children who admit into the emergency department (ED). However the collection of urine from young children is time consuming process. So many children and their family guardian waste time until medical disposition established.
In 2013, Maria Luisa Herreros Fernandez etc have suggested a new urine collection technique for newborn, that bladder and lumbar stimulation technique is fast and safe.
The aim of this study is to determine clinical efficacy of bladder and lumbar stimulation technique (BLST) for pediatric patient in ED.
Read the detailed description
Bladder and lumbar stimulation technic
Step 1
- Oral or IV hydration : Aprropriate to the weight of the children
Step 2 - Bladder stimulation : Gentle tapping in the suprapubic area at a frequency of 100 taps per minute for 30 sec
Step 3
- Lumbar stimulation : Lumbar paravertebral zone in the lower back with a light circular massage for 30 sec
Both stimulation manoeuvres are repeated until micturition starts and a midstream urine sample can be caught in a sterile collector
- Conditions
- Urinary Tract Infection, Unspecified Fever
- Being tested
- Bladder and lumbar stimulation technic
- 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.
Bladder and lumbar stimulation technicOther
Also called BLST
| Study group | Role | What they receive |
|---|---|---|
| bladder and lumbar stimulation | Experimental | Apply bladder and lumbar stimulation Receives: Other: Bladder and lumbar stimulation technic |
| Control group | No intervention | Ordinary pediatric urine collection bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of bladder and lumbar stimulation techninc
Success is defined as the collection of a sample within 10 min of starting the stimulation manoeuvres
Measured: 10 min
Secondary outcomes (1)
Urine collection time
Urine collection time is defined as time from ordering urine analysis to collection of a urine sample
Measured: 3 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeju National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kang Jeong Ho, Jeju National University Hospital
- Investigators
- Sung wook Song, Study chair, Emergency department of Jeju national university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117102
- Sponsor's protocol ID
- BLSTJEJUNUH
- Acronym
- BLST
- Status last verified
- Apr 2014
- First submitted
- 14 Apr 2014
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Herreros Fernandez ML, Gonzalez Merino N, Tagarro Garcia A, Perez Seoane B, de la Serna Martinez M, Contreras Abad MT, Garcia-Pose A. A new technique for fast and safe collection of urine in newborns. Arch Dis Child. 2013 Jan;98(1):27-9. doi: 10.1136/archdischild-2012-301872. Epub 2012 Nov 21.
PubMed 23172785
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Use of a New Technique for Pediatric Urine Collection on the Length of Stay in the Emergency Department: Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02117102
- Acronym / sponsor ID
- BLST / BLSTJEJUNUH
- Conditions
- Urinary Tract Infection, Unspecified Fever
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Jeju National University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 17 Apr 2014 (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.
Urinary tract infection is most common serious bacterial infection in children who admit into the emergency department (ED). However the collection of urine from young children is time consuming process. So many children and their family guardian waste time until medical disposition established.
In 2013, Maria Luisa Herreros Fernandez etc have suggested a new urine collection technique for newborn, that bladder and lumbar stimulation technique is fast and safe.
The aim of this study is to determine clinical efficacy of bladder and lumbar stimulation technique (BLST) for pediatric patient in ED.
Detailed description
Bladder and lumbar stimulation technic
Step 1
- Oral or IV hydration : Aprropriate to the weight of the children
Step 2 - Bladder stimulation : Gentle tapping in the suprapubic area at a frequency of 100 taps per minute for 30 sec
Step 3
- Lumbar stimulation : Lumbar paravertebral zone in the lower back with a light circular massage for 30 sec
Both stimulation manoeuvres are repeated until micturition starts and a midstream urine sample can be caught in a sterile collector
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bladder and lumbar stimulation | Experimental | Other: Bladder and lumbar stimulation technicApply bladder and lumbar stimulation |
| Control group | No intervention | –Ordinary pediatric urine collection bag |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children have unspecific fever and requiring and urine test
Key exclusion criteria (3 listed)
- Initial shock state
- History of congenial urinary tract abnormality
- Parents who have declined taking part in the research
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 |
|---|---|---|
| Bladder and lumbar stimulation technicAlso: BLST | Other | bladder and lumbar stimulation |
Primary outcome
Success rate of bladder and lumbar stimulation techninc
Time frame: 10 min
Success is defined as the collection of a sample within 10 min of starting the stimulation manoeuvres
1 secondary outcome
Urine collection time
Time frame: 3 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
- Background: PubMed 23172785Herreros Fernandez ML, Gonzalez Merino N, Tagarro Garcia A, Perez Seoane B, de la Serna Martinez M, Contreras Abad MT, Garcia-Pose A. A new technique for fast and safe collection of urine in newborns. Arch Dis Child. 2013 Jan;98(1):27-9. doi: 10.1136/archdischild-2012-301872. Epub 2012 Nov 21.
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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.
Jeong Ho Kang contact
Sung wook Song study chair
Emergency department of Jeju national university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder and lumbar stimulation technic in people with Urinary Tract Infection and Unspecified Fever, run by Jeju National University Hospital at 1 site in South Korea.
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 3 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 17 Apr 2014. 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 South Korea. 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?
Contact Jeong Ho Kang (sivakjh1234@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of bladder and lumbar stimulation techninc (time frame: 10 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02117102, which also lists 1 linked publication.
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 17 Apr 2014.