Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in Children.

S

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

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

Trial contacts and locations

1

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Central trial contact

Luz I Zamudio, MD; Jesus J Martinez, MD

Data sourced from clinicaltrials.gov

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