"Alcohol Based Hand Sanitizers for the Prevention of Acute Diarrheal Disease and Acute Respiratory Infection in Children Under 5 Attending Childcare Centers in Bogotá, Cundinamarca and Tolima, in Colombia: a Cluster Randomized Control Trial"
August 20, 2009 updated by: Fundación Santa Fe de Bogota
The purpose of this study is to conduct a Randomized Control Trial (RCT) in a developing country setting in order to evaluate the role of alcohol based hand sanitizers (ABHS) in preventing the transmission of infectious diseases in areas where water is a scarce resource.
The investigators want to find out if the use of ABHS reduces the incidence of two leading causes of morbidity and mortality in children under 5 years of age in the developing world: acute diarrheal disease (ADD) and acute respiratory infections (ARI).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
We performed a cluster, RCT in child care centers located in six urban settings of Colombia with intermittent tap water availability.
A total of 1727 children between 1 and 5 years of age distributed in 42 childcare centers participated in the study.
The intervention consisted on installation of ABHS gel dispensers and training on their use by participating children in child care centers.
Centers assigned to the control group were recommended to continue with current hand hygiene practices.
Child care centers matched by location, size and sanitary conditions were randomly assigned to intervention or control.
Cases of Acute Diarrheal Disease (ADD) and Acute Respiratory Infections ARI were identified through teacher reported signs and symptoms of disease and validated by a trained physician.
We also monitored adverse events potentially related to ABHS.
To compare incidence rates between study arms we modeled the number of episodes of ADD and ARI per child using a Cox proportional hazards multiple regression with random effects.
Study Type
Interventional
Enrollment (Actual)
1727
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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D.c.
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Bogotá, D.c., Colombia
- Fundación Santa Fe de Bogotá
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children between 1 and 5 years of age
- Attending child care centers with limited tap water availability
Exclusion Criteria:
- Chronic conditions
- Not willing to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: ABHS use
Centers assigned to the intervention group were provided with ABHS dispensers with a gel solution with ethyl alcohol at 62% as active ingredient (Purell®, GOJO Industries, Dayton, Ohio).
Proper safety measures were followed.
Standardized ABHS training workshops for staff and children in centers allocated to the intervention were carried out simultaneously with dispenser installation.
Thirty minute refresher sessions about ABHS technique were provided to staff and children on a monthly basis, for a total of 8 sessions per center.
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Centers assigned to the intervention group were provided with ABHS dispensers with a gel solution with ethyl alcohol at 62% as active ingredient (Purell®, GOJO Industries, Dayton, Ohio). A total of 85 dispensers were installed, one dispenser was installed in each center of size less than 14 children, and one per classroom plus an additional one for common areas in centers with more than 28 children. Proper safety measures were followed. Standardized ABHS training workshops for staff and children in centers allocated to the intervention were carried out simultaneously with dispenser installation. Thirty minute refresher sessions about ABHS technique were provided to staff and children on a monthly basis, for a total of 8 sessions per center.
Other Names:
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No Intervention: No treatment
Centers assigned to the control group received no hand hygiene recommendations other than to continue with current hand hygiene practices and no further information on hand hygiene other than the general information received before trial initiation was provided.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Number of Cases of Acute Diarrheal Disease Number of Cases of Acute Respiratory Infection
Time Frame: April - December 2008
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April - December 2008
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Number of Adverse Events
Time Frame: April - December 2008
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April - December 2008
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Juan C Correa, MD, Fundación Santa Fe de Bogotá
- Principal Investigator: Diana Pinto, MD, Fedesarrollo, Pontificia Universidad Javeriana
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
August 20, 2009
First Submitted That Met QC Criteria
August 20, 2009
First Posted (Estimate)
August 21, 2009
Study Record Updates
Last Update Posted (Estimate)
August 21, 2009
Last Update Submitted That Met QC Criteria
August 20, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMPCOL298
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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