Comparison of the effect of Rosemary ointment and Eucerine ointment on the incidence, severity of phlebitis and peripheral vascular catheter survival time in hospitalized Neonates
Determining the effect of Rosemary ointment and Eucerine ointment on the incidence, severity of phlebitis and peripheral vascular catheter survival time in hospitalized Neonates
Design
Clinical trial with a control group and parallel groups, triple blinded, randomized
Settings and conduct
This research will be conducted in the neonatal and NICU wards of Ganjavian Hospital in Dezful. The study is triple blind (statistical counselor, patient, researcher and colleagues ) in which secretary of the ward (aware of the type intervention) who is not a member of the research team, assigns the baby code A (intervention) or code B (control) at the time of neonatal admitted. Then Rosemary ointment or Euccerine, which has already been placed in similar tubes with labels A and B in collaboration with the pharmacy, is given to research colleagues (fixed IV line) from the pharmacy shelf.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged 1 to 30 days, intravenous access for at least 72 hours.
Non-inclusion criteria: perinatal and peripheral vascular disease, usage of steroidal drugs, heparin, nitroglycerin.
Intervention groups
Intervention group: from the time of fixing the IV canulla, 0.5 CC of the Rosemary ointment every 24 hours up will be used until 72 hours. Control group: Since fixing the IV canulla, 0.5 CC Eucerine ointment (placebo) every 24 hours will be used up to 72 hours in the distal part of the IV canulla.
Main outcome variables
Incidence and severity of Phlebitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170607034381N5
Registration date:2020-06-10, 1399/03/21
Registration timing:registered_while_recruiting
Last update:2020-06-10, 1399/03/21
Update count:0
Registration date
2020-06-10, 1399/03/21
Registrant information
Name
Ferdos Pelarak
Name of organization / entity
Dezful Azad University
Country
Iran (Islamic Republic of)
Phone
+98 916 941 7091
Email address
pelarak.f@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-10, 1398/12/20
Expected recruitment end date
2020-08-10, 1399/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Rosemary ointment and Eucerine ointment on the incidence, severity of phlebitis and peripheral vascular catheter survival time in hospitalized Neonates
Public title
The effect of Rosemary ointment on phlebitis and survival time of IV canulla
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age 1 to 30 day
intravenous access for at least 72 hours
Exclusion criteria:
Suffering from skin and peripheral vascular diseases
Taking steroid medications
Heparin injection
Nitro glycerin (injectable, topical)
Age
From 1 day old to 30 days old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The strata are based on the hospital ward, age category, and sex of the neonate using the stratified random allocation method (8 classes). Inside each class, to assign neonates to two groups, Permuted block randomization methods and the table of random numbers are used (1 to 1 allocation).
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is triple blind (statistical counselor, patient, researcher and colleagues ) in which secretary of the ward (aware of the type intervention) who is not a member of the research team, assigns the baby code A (intervention) or code B (control) at the time of neonatal admitted. Then Rosemary ointment or Euccerine, which has already been placed in similar tubes with labels A and B in collaboration with the pharmacy, is given to research colleagues (fixed IV line) from the pharmacy shelf.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Khorram-Abad University of Medical Sciences
Street address
Khorramabad University of Medical Sciences; 5th km of Khorramabad (Kamalvand)
City
Khorram-Abad
Province
Lorestan
Postal code
6813833946
Approval date
2020-03-02, 1398/12/12
Ethics committee reference number
IR.LUMS.REC.1398.263
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
Incidence of Phlebitis
Timepoint
24،48،72 hourse after catheter placement
Method of measurement
Phlebitis scale
Secondary outcomes
1
Description
Severity of phlebitis
Timepoint
24،48،72 hourse after catheter placement
Method of measurement
Phlebitis scale
Intervention groups
1
Description
Intervention group: The rosemary ointment made by Gol Daroo Company is rubbed in the distal part of the IV canulla in an area of 1 cm squared and will be covered with a sterile coating (IV canulla adhesive). It is replaced every 24 hours and checked and registered for phlebitis up to 72 hours.
Category
Prevention
2
Description
Control group:The Eucerine ointment as a placebo made by Gol Daroo Company is rubbed in the distal part of the IV canulla in an area of 1 cm squared and will be covered with a sterile coating (IV canulla adhesive). It is replaced every 24 hours and checked and registered for phlebitis up to 72 hours
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Ganjavian Hospital
Full name of responsible person
Azadeh Nasrollahnejad
Street address
At the beginning of Dezful-Andimeshk road
City
Dezful
Province
Khouzestan
Postal code
64611-33549
Phone
+98 61 4255 7035
Email
a.nasrolahnejad1403@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr.Kobra Karami
Street address
Khorramabad University of Medical Sciences; 5th km of Khorramabad (Kamalvand)
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3312 0133
Email
kbkarami@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr.Kobra Karami
Position
Associate Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Khorramabad University of Medical Sciences; 5th km of Khorramabad (Kamalvand)
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3312 0138
Email
kbkarami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr.Kobra Karami
Position
Associate Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Khorramabad University of Medical Sciences; 5th km of Khorramabad (Kamalvand)
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3312 0138
Email
kbkarami@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Azadeh Nasrollah.nejad
Position
MSc Student of Pediatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hafez Street
City
Dezful
Province
Khouzestan
Postal code
6461133549
Phone
+98 61 4255 7035
Email
n.nasrolahnejad1403@gmail.com
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
No more information
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