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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02117102
Other study ID # BLSTJEJUNUH
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 14, 2014
Last updated April 15, 2014
Start date May 2014
Est. completion date December 2014

Study information

Verified date April 2014
Source Jeju National University Hospital
Contact Jeong Ho Kang
Email sivakjh1234@gmail.com
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical 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.

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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 170
Est. completion date December 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 36 Months
Eligibility Inclusion Criteria:

- Children have unspecific fever and requiring and urine test

Exclusion Criteria:

- Initial shock state

- History of congenial urinary tract abnormality

- Parents who have declined taking part in the research

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Other:
Bladder and lumbar stimulation technic


Locations

Country Name City State
Korea, Republic of Jeju national university hospital Jeju City Jeju special governing province

Sponsors (1)

Lead Sponsor Collaborator
Jeju National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Herreros Fernández ML, González Merino N, Tagarro García A, Pérez Seoane B, de la Serna Martínez M, Contreras Abad MT, García-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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 10 min No
Secondary Urine collection time Urine collection time is defined as time from ordering urine analysis to collection of a urine sample 3 hour No
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