The aim of this study is to evaluate the effect of time and temperature on children's urine culture (U/C) results using bag or midstream sampling. This is a randomized not blinded clinical trial on 60 patients. We will assign 60 patients into 2 groups. Urine sampling will be done using bag and midstream methods for groups 1 and 2, respectively. U/C results of samples obtained within 1 hour from sampling (as true results) would be compared with the results of 2 and 4 hours after sampling (as results containing false positives) for each patient. 2 and 4 hour samples would be randomly kept in refrigerator or out of refrigerator to see if keeping in cold place can decrease the rate of false positive.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110287892N3
Registration date:2011-11-15, 1390/08/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-11-15, 1390/08/24
Registrant information
Name
Anoosh Azarfar
Name of organization / entity
Mashhad University of Medical Sciences, Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 51 1606 1227
Email address
azarfara@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center for children's health of Tabriz Medical University
Expected recruitment start date
2011-11-22, 1390/09/01
Expected recruitment end date
2012-02-20, 1390/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of time and temperature on urine culture results in children using urine bag or midstream sample.
Public title
Influence of time and tempereture on children's urine culture result
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: All patients under 12 years of age who refer to the hospital for U/A and U/C and their urine samples have brought to the lab within 1 hour
Exclusion criteria: inpatient cases; patients older than 12; patients with insufficient urine samples to perform urine culture for latter hours; urine samples brought to the lab after 1 hour from sampling
Age
To 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Vice-Chancellor for Research, Tabriz University of Medical Sciences, Daneshgah square
City
Tabriz
Postal code
51665118
Approval date
2010-03-06, 1388/12/15
Ethics committee reference number
2735/4/5
Health conditions studied
1
Description of health condition studied
Urinary tract infection
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified
Primary outcomes
1
Description
Urine Culture (U/C)
Timepoint
2 and 4 hours
Method of measurement
Microscope
Secondary outcomes
1
Description
Urine culture positive
Timepoint
2 and 4 hours
Method of measurement
Microscope
Intervention groups
1
Description
Urine sampling using urine bag
Category
Diagnosis
2
Description
Urine sampling using midstream sampling
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children's hospital
Full name of responsible person
Anoosh azarfar
Street address
Children's hospital-sheshgelan st.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center for children's health
Full name of responsible person
mohammad barzegar, center's chief
Street address
Children's hospital-sheshgelan st.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center for children's health
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz Medical University
Full name of responsible person
Anoosh azarfar
Position
Asisstant professor, Subspecialist in pediatrics nephrology
Other areas of specialty/work
Street address
Children's hospital-sheshgelan st.
City
Tabriz
Postal code
Phone
+98 41 1658 4153
Fax
Email
azarfar132@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz Medical University
Full name of responsible person
Anoosh Azarfar
Position
Subspecialist in pediatrics nephrology
Other areas of specialty/work
Street address
Children's hospital-sheshgelan st
City
Tabriz
Postal code
Phone
+98 41 1658 4153
Fax
Email
azarfar132@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Medical University
Full name of responsible person
Anoosh Azarfar
Position
Asisstant professor, Subspecialist in pediatrics nephrology
Other areas of specialty/work
Street address
Children's hospital-sheshgelan st.
City
Tabriz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)