Comparing the effects of Chlorhexidine 2% and Betadine-Alcohol on phlebitis after peripheral vascular catheterization in preterm neonates
Design
The clinical trial consisted of 140 samples(Each group n= 70) in two intervention groups, with parallel groups, single blinded, randomized using block randomization method
Settings and conduct
Premature infants admitted to the neonatal intensive care unit of Kamali hospital in Karaj who need catheterization of the peripheral vein for the first time, will enter the study in an accessible way and then will be randomly divided into two groups.In group 1, the catheterization site is disinfected with chlorhexidine gluconate 2% solution and in group 2, betadine 10% and alcohol 70% are used to disinfect the catheterization site in two stages
Participants/Inclusion and exclusion criteria
Inclusion criterion: Premature neonates who need peripheral vascular catheterization for the first time.
Exclusion criteria: Signs of inflammation at the selected site of catheter insertion; symptoms of bacteremia; symptoms of septicemia such as fever greater than 38. C, leukocytosis, tachycardia and respiratory rate greater than 60
Intervention groups
Intervention group 1: The skin of the catheterization area is disinfected with chlorhexidine gluconate 2% solution.
Intervention group 2: The skin of the catheterization area is first disinfected with Iodine 10%, then allowed to dry with Iodine and then discharged with alcohol 70% and when it dry , the catheterization will be done
Main outcome variables
Phlebitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170620034653N5
Registration date:2020-05-16, 1399/02/27
Registration timing:registered_while_recruiting
Last update:2020-05-16, 1399/02/27
Update count:0
Registration date
2020-05-16, 1399/02/27
Registrant information
Name
Zahra Tayebi Myaneh
Name of organization / entity
Qazvin University of medical science
Country
Iran (Islamic Republic of)
Phone
+98 28 3224 8614
Email address
z.tayebi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Chlorhexidine 2% and Betadine-Alcohol on Phlebitis after Peripheral Vascular Catheterization in Preterm Neonates
Public title
Comparison of the Effectiveness of Chlorhexidine 2% and Betadine-Alcohol on Phlebitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Premature neonate
For the first time in the intensive care unit, the neonate needs peripheral vein catheterization
Exclusion criteria:
Symptoms of septicemia in neonate
The presence of bacteremia in the neonate (positive primary CRP or positive blood culture)
Symptoms of inflammation in the area used for venous catheterization
Age
From 224 days old to 259 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation by blocks of size 4
Blinding (investigator's opinion)
Single blinded
Blinding description
The nurse will use chlorhexidine 2% solution for disinfection of the catheterization site in the intervention group 1 and will use the usual method named Betadine-Alcohol in the Intervention group 2. Parents of Neonate with informed consent and awareness of intervention will be kept unaware of being neonates in either intervention groups 1 or 2.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Deputy of research and technology; Safarian alley; Golshahr street; Shahid Beheshti boulevard
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2019-09-14, 1398/06/23
Ethics committee reference number
IR.ABZUMS.REC.1398.105
Health conditions studied
1
Description of health condition studied
Phlebitis
ICD-10 code
I80
ICD-10 code description
Phlebitis and thrombophlebitis
Primary outcomes
1
Description
Phlebitis
Timepoint
The Nurse will check the Catheter site before each injection of the Drug and every 8 hours (According to the Hospital Policy, the maximum life expectancy of peripheral vascular catheter in Neonates is 72 hours)
Method of measurement
Standard Phlebitis Tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The Skin of the Catheterization area is disinfected with Chlorhexidine Gluconate 2% solution
Category
Prevention
2
Description
Intervention group:The Skin of the Catheterization area is first disinfected with Iodine 10%, then allowed to dry and after that Iodine will be removed by Alcohol 70% and when it dry , the Catheterization will be done
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamali Hospital
Full name of responsible person
Zahra Tayebi Myaneh
Street address
Alborz School of Nursing; Golestan 1 avenue; Baghestan boulevard
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3334 6007
Fax
+98 26 3430 1666
Email
z.tayebi@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Mohamad Norysepehr
Street address
Deputy of research and technology; Safarian alley; Golshahr street; Shahid Beheshti boulevard
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
tayebi.medical@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz University of Medical Sciences
Proportion provided by this source
80
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
Alborz University of Medical Sciences
Full name of responsible person
Zahra Tayebi Myaneh
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alborz School of Nursing; Golestan 1 avenue; Baghestan boulevard
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3334 6007
Email
z.tayebi@abzums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Zahra Tayebi Myaneh
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alborz School of Nursing; Golestan 1 avenue; Baghestan boulevard
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3334 5007
Email
z.tayebi@abzums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Zahra Tayebi Myaneh
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alborz School of Nursing; Golestan 1 avenue; Baghestan boulevard
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3334 6007
Email
z.tayebi@abzums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available