Back to resultsChlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in Children.
Primary Purpose
Mechanical Ventilation for More Than 48 Hours.
Status
Unknown status
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
0.12% chlorhexidine solution
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mechanical Ventilation for More Than 48 Hours.
Eligibility Criteria
Inclusion Criteria:
- Children aged 1 month to 18 years admitted to the intensive care unit.
- Intubated for more than 48 hours.
Exclusion Criteria:
- Clinical or radiological diagnosis of pneumonia previous to the endotracheal intubation.
- Allergy to chlorhexidine.
- Known immune deficiency.
Elimination Criteria:
- Transfer to another hospital.
Sites / Locations
- Sinaloa Pediatric HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
0.12% Chlorhexidine
Placebo
Arm Description
Bexident® (0.12% chlorhexidine) solution, applied topically, every 8 hrs.
7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs.
Outcomes
Primary Outcome Measures
Incidence of ventilator associated pneumonia
Secondary Outcome Measures
Mortality
Days of mechanical ventilation
Length of stay
Full Information
NCT ID
NCT01883596
First Posted
June 11, 2013
Last Updated
December 7, 2015
Sponsor
Sinaloa Pediatric Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01883596
Brief Title
Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in Children.
Official Title
Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in a Pediatric Intensive Care Unit.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sinaloa Pediatric Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the efficacy of prophylaxis with 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.
Detailed Description
Randomised controlled trial to determine the efficacy of 0.12% chlorhexidine gluconate compared with placebo to prevent ventilator associated pneumonia in children admitted to a pediatric critical care unit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation for More Than 48 Hours.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
0.12% Chlorhexidine
Arm Type
Experimental
Arm Description
Bexident® (0.12% chlorhexidine) solution, applied topically, every 8 hrs.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs.
Intervention Type
Drug
Intervention Name(s)
0.12% chlorhexidine solution
Other Intervention Name(s)
Peridex, Betasept, PerioGard.
Intervention Description
Bexident® (0.12% chlorhexidine solution)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs.
Primary Outcome Measure Information:
Title
Incidence of ventilator associated pneumonia
Time Frame
Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks
Title
Days of mechanical ventilation
Time Frame
From date of randomization until the date of death or date of extubation, whichever comes first, an expected average of 2 weeks
Title
Length of stay
Time Frame
From date of randomization until the date of death or date of discharge from the intensive care unit, an expected average of 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children aged 1 month to 18 years admitted to the intensive care unit.
Intubated for more than 48 hours.
Exclusion Criteria:
Clinical or radiological diagnosis of pneumonia previous to the endotracheal intubation.
Allergy to chlorhexidine.
Known immune deficiency.
Elimination Criteria:
Transfer to another hospital.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesus J Martinez, MD
Phone
+52 (667) 7139004
Ext
274
Email
jjmtz64@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luz I Zamudio, MD
Phone
+52 (667) 7164686
Email
zluz_isabel@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesus J Martinez, MD
Organizational Affiliation
Sinaloa Pediatric Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sinaloa Pediatric Hospital
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80200
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus J Martinez, MD
Phone
+52 (667) 7139004
Ext
274
Email
jjmtz64@hotmail.com
First Name & Middle Initial & Last Name & Degree
Luz I Zamudio, MD
Phone
+52 (667) 7164686
Email
zluz_isabel@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jesus J Martinez, MD
12. IPD Sharing Statement
Learn more about this trial
Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in Children.
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