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Chlorhexidine Gluconate for Prevention of Ventilator Associated Pneumonia in Children.

NCT ID: NCT01883596

Last Updated: 2015-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mechanical Ventilation for More Than 48 Hours.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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0.12% Chlorhexidine

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

Group Type EXPERIMENTAL

0.12% chlorhexidine solution

Intervention Type DRUG

Bexident® (0.12% chlorhexidine solution)

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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0.12% chlorhexidine solution

Bexident® (0.12% chlorhexidine solution)

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Peridex, Betasept, PerioGard.

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sinaloa Pediatric Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jesús Javier Martínez-García

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jesus J Martinez, MD

Role: STUDY_CHAIR

Sinaloa Pediatric Hospital

Locations

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Sinaloa Pediatric Hospital

Culiacán, Sinaloa, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Jesus J Martinez, MD

Role: CONTACT

[email protected]
+52 (667) 7139004 ext. 274

Luz I Zamudio, MD

Role: CONTACT

[email protected]
+52 (667) 7164686

Facility Contacts

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Jesus J Martinez, MD

Role: primary

[email protected]
+52 (667) 7139004 ext. 274

Luz I Zamudio, MD

Role: backup

[email protected]
+52 (667) 7164686

Other Identifiers

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HPS-02

Identifier Type: -

Identifier Source: org_study_id