Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in Children.

Sinaloa Pediatric Hospital

Status and phase: Unknown; Phase 4

Conditions: Mechanical Ventilation for More Than 48 Hours.

Treatments: Drug: 0.12% chlorhexidine solution; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01883596

HPS-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

0.12% Chlorhexidine

Experimental group

Description:

Bexident® (0.12% chlorhexidine) solution, applied topically, every 8 hrs.

Treatment:

Drug: 0.12% chlorhexidine solution

Placebo

Placebo Comparator group

Description:

7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs.

Treatment:

Drug: Placebo