Comparing the success rate of the three urine sampling methods with Catheterization, Suprapubic Aspiration with and without Guidance in Neonates and Infants younger than three month suspicious to Urinary Tract Infection
To determine and compare the success rate of three urine sampling methods with catheterization, suprapubic aspiration with and without guidance in infants suspicious to urinary tract infection
Design
clinical trial with control group
Settings and conduct
Neonates and infants hospitalized in 17 Shahrivar Hospital suspicious to Urinary Tract Infection are divided into 3 therapeutic groups: A, B, and C according to block randomization.
Group A: Sampling with Catheterization
Group B: Sampling with Suprapubic Aspiration
Group C: Sampling with Ultrasonography-guided Suprapubic Aspiration
There is a maximum limit of three-time efforts for sampling
Participants/Inclusion and exclusion criteria
Entry condition:
َAll the Neonates and Infants younger than 3 month suspicious to Urinary Tract Infection
No-entry conditions:
Infection of the examed -skin site
Anatomical disorders of Urinary Tract
Bleeding Disorders and Uncorrected Thrombocytopenia
Enlarged abdomen and Inrta-abdominal Viscera
Intervention groups
Group A: Catheterization
Group B: Suprapubic Aspiration
Group C: Ultrasonography-guided Suprapubic Aspiration
Main outcome variables
Overall success rate of each sampling method
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090111001545N3
Registration date:2018-04-09, 1397/01/20
Registration timing:registered_while_recruiting
Last update:2018-04-09, 1397/01/20
Update count:0
Registration date
2018-04-09, 1397/01/20
Registrant information
Name
Hamidreza Badeli
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 9523
Email address
badeli@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the success rate of the three urine sampling methods with Catheterization, Suprapubic Aspiration with and without Guidance in Neonates and Infants younger than three month suspicious to Urinary Tract Infection
Public title
Comparing the success rate of the three urine sampling methods with Catheterization, Suprapubic Aspiration with and without Guidance in neonates and infants younger than three month with Urinary Tract Infection
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
َAll the Neonates and Infants younger than 3 month suspicious to Urinary Tract Infection
Exclusion criteria:
Infection of the examed -skin site
Anatomical disorders of Urinary Tract
Bleeding Disorders and Uncorrected Thrombocytopenia
Enlarged abdomen and Intra-abdominal Viscera
Age
From 1 day old to 3 months old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be performed by randomization method. Neonates and infants will be classified into 3 therapeutic groups by block randomization.
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 Guilan University of Medical Sciences
Street address
Namjou Ave,Shadid Siadati St,Rasht
City
Rasht
Province
Guilan
Postal code
4144654839
Approval date
2016-12-15, 1395/09/25
Ethics committee reference number
IR.GUMS.REC.1395.365
Health conditions studied
1
Description of health condition studied
Success rate of urine sampling methods
ICD-10 code
P39.3
ICD-10 code description
Neonatal urinary tract infection
Primary outcomes
1
Description
Overall success rate of each sampling method
Timepoint
Three times
Method of measurement
Catheterization,Suprapubic aspiration without guidance,Suprapubic aspiration with guidance
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The group in which urine sample is collected by Catheterization
Category
Diagnosis
2
Description
Intervention group 2: The group in which urine sample is collected by Suprapubic Aspiration
Category
Diagnosis
3
Description
Intervention group 3: The group in which urine sample is collected by Ultrasonography-guided suprapubic Aspiration
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
17-Shahrivar Children Hospital
Full name of responsible person
Hamidreza Badeli
Street address
Namjou Ave,Shadid Siadati St,Rasht
City
Rasht
Province
Guilan
Postal code
41144654839
Phone
+98 13 3336 9002
Fax
+98 13 3336 9070
Email
17shahrivar@gums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
Namjou Ave, Shadid Siadati St, Rasht
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9002
Fax
Email
research@gums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Hamidreza Badeli
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Namjou Ave,Shadid Siadati St,Rasht
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9002
Fax
+98 13 3336 9070
Email
badeli@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Hamidreza Badeli
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Namjou Ave,Shadid Siadati St,Rasht
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9391
Fax
Email
badeli@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Hamidreza Badeli
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Namjou Ave,Shadid Siadati St,Rasht
City
Rasht
Province
Guilan
Postal code
414465839
Phone
+98 13 3336 9002
Email
badeli@gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD