Comparison of the effect of Chlorhexidine mouthwash with Dine mouthwash on prevention of ventilator-associated pneumonia in pediatric intensive care unit
The aim of this study is comparing the effect of chlorhexidine mouthwash with Dine mouthwash on prevention of ventilator-associated pneumonia in patients in PICU
Design
Clinical trial , phase 2 , double blinded, 80 patients between 2 months and 14 years old, admitted in PICU , randomized in two groups of Dine or Chlorhexidin mouthwash recipients
Settings and conduct
This is a double blinded study on 80 patients admitted in PICU of Emam Hosein hospital of Esfahan , who receive Dine or Chlorhexidin mouthwash and will be compared about incidence of pneumonia
Participants/Inclusion and exclusion criteria
Patients with age of 2 months to 14 years
Patients who need mechanical ventilation for at least 48 hours
Admission in pediatric intensive care unit
No Intubation before admission in PICU
No Oral or perioral lesions
No Immune deficiency
No Admission with causes of infectious or respiratory diseases
No Use of antibiotics before admission
No Sensitivity to herbal medication in past medical history
Intervention groups
Patients who receive Dine or Chlorhexidin mouthwash
Main outcome variables
Incidence of pneumonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180520039739N2
Registration date:2018-11-26, 1397/09/05
Registration timing:registered_while_recruiting
Last update:2018-11-26, 1397/09/05
Update count:0
Registration date
2018-11-26, 1397/09/05
Registrant information
Name
Mohammadreza Habibzadeh siahroodkolaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3532 0551
Email address
M.habibzadeh@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Chlorhexidine mouthwash with Dine mouthwash on prevention of ventilator-associated pneumonia in pediatric intensive care unit
Public title
Evaluation of effect of chlorhexidine on prevention of ventilator associated pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with age of 2 months to 14 years
Patients who need mechanical ventilation for at least 48 hours
Admission in pediatric intensive care unit
Exclusion criteria:
Intubation before admission in PICU
Oral or perioral lesions
Immune deficiency
Admission with causes of infectious or respiratory diseases
Use of antibiotics before admission
Sensitivity to herbal medication in past medical history
Age
From 2 months old to 14 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization(random number table) : even numbers for Chlorhexidin and odds for Dine groups
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and their nurses are not aware of the kind of mouthwash and executor of plan will give the mouthwash to the nurses.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan university of medical sciences
Street address
Esfahan university of medical sciences , Hezarjerib Ave.
City
Esfahan
Province
Isfehan
Postal code
ندارد
Approval date
2017-04-25, 1396/02/05
Ethics committee reference number
IR.MUI.REC.1396.30975
Health conditions studied
1
Description of health condition studied
Ventilator associated pneumonia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Incidence of pneumonia
Timepoint
In 5 days
Method of measurement
Infectious Diseases Society of America Guidelines and American Thoracic Society guidelines
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: treatment with 10 cc of 0.2% chlorhexidine gluconate mouthwash (Emad darou company) 3 times per day for 5 days
Category
Treatment - Drugs
2
Description
Intervention group: treatment with 20 drop of dine mouthwash (Dineh Iran) 3 times per day for 5 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hosein hospital
Full name of responsible person
Mohammadreza Habibzadeh
Street address
Emam Khomeini
City
Esfahan
Province
Isfehan
Postal code
ندارد
Email
gsmhabibzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Hezarjerib Ave.
City
Esfahan
Province
Isfehan
Postal code
ندارد
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Habibzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjerib Ave.
City
Esfahan
Province
Isfehan
Postal code
ندارد
Phone
+98 913 389 1027
Email
gsmhabibzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Habibzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjerib Ave.
City
Esfahan
Province
Isfehan
Postal code
ندارد
Phone
+98 913 389 1027
Email
gsmhabibzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Habibzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjerib Ave.
City
Esfahan
Province
Isfehan
Postal code
ندارد
Phone
+98 913 389 1027
Email
gsmhabibzadeh@yahoo.com
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