NCT02117102

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

Enrollment Period

4 months

First QC Date

April 14, 2014

Last Update Submit

April 15, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Urine collection time

    3 hour

Study Arms (2)

bladder and lumbar stimulation

EXPERIMENTAL

Apply bladder and lumbar stimulation

Other: Bladder and lumbar stimulation technic

Control group

NO INTERVENTION

Ordinary pediatric urine collection bag

Interventions

Also known as: BLST
bladder and lumbar stimulation

Eligibility Criteria

Age6 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children have unspecific fever and requiring and urine test

You may not qualify if:

  • Initial shock state
  • History of congenial urinary tract abnormality
  • Parents who have declined taking part in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jeju national university hospital

Jeju City, Jeju Special Governing Province, 690 767, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 23172785BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Sung wook Song

    Emergency department of Jeju national university hospital

    STUDY CHAIR

Central Study Contacts

Jeong Ho Kang

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency department

Study Record Dates

First Submitted

April 14, 2014

First Posted

April 17, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

April 17, 2014

Record last verified: 2014-04

Locations