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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.12% Chlorhexidine | Experimental | Bexident® (0.12% chlorhexidine) solution, applied topically, every 8 hrs. |
|
| Placebo | Placebo Comparator | 7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.12% chlorhexidine solution | Drug | Bexident® (0.12% chlorhexidine solution) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ventilator associated pneumonia | Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks | |
| Days of mechanical ventilation | From date of randomization until the date of death or date of extubation, whichever comes first, an expected average of 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Elimination Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jesus J Martinez, MD | Contact | +52 (667) 7139004 | 274 | jjmtz64@hotmail.com |
| Luz I Zamudio, MD | Contact | +52 (667) 7164686 | zluz_isabel@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jesus J Martinez, MD | Sinaloa Pediatric Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sinaloa Pediatric Hospital | Recruiting | Culiacán | Sinaloa | 80200 | Mexico |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | 7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs. |
|
| Length of stay | From date of randomization until the date of death or date of discharge from the intensive care unit, an expected average of 2 weeks |