Mechanical Ventilation for More Than 48 Hours. Clinical Trial
Official title:
Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in a Pediatric Intensive Care Unit.
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 18 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mexico | Sinaloa Pediatric Hospital | Culiacan | Sinaloa |
Lead Sponsor | Collaborator |
---|---|
Sinaloa Pediatric Hospital |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of ventilator associated pneumonia | Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks | No | |
Secondary | Mortality | Participants will be followed for the duration of intensive care unit stay, an expected average of 2 weeks | No | |
Secondary | 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 | No | |
Secondary | 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 | No |