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"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"

Primary Purpose

Acute Diarrheal Disease, Acute Respiratory Infection

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
ABHS use
Sponsored by
Fundación Santa Fe de Bogota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Diarrheal Disease focused on measuring Health Production, Government Policy; Regulation; Public Health, Government Policy; Provision and Effects of Welfare Programs, Gastrointestinal diseases, Respiratory Tract Infections, Diarrhea, Ethanol, Child, Preschool, Handwashing

Eligibility Criteria

1 Year - 5 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fundación Santa Fe de Bogotá

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ABHS use

No treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Cases of Acute Diarrheal Disease Number of Cases of Acute Respiratory Infection

Secondary Outcome Measures

Number of Adverse Events

Full Information

First Posted
August 20, 2009
Last Updated
August 20, 2009
Sponsor
Fundación Santa Fe de Bogota
Collaborators
Fedesarrollo, Pontificia Universidad Javeriana, Global Development Network
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1. Study Identification

Unique Protocol Identification Number
NCT00963391
Brief Title
"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"
Official Title
"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"
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fundación Santa Fe de Bogota
Collaborators
Fedesarrollo, Pontificia Universidad Javeriana, Global Development Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Diarrheal Disease, Acute Respiratory Infection
Keywords
Health Production, Government Policy; Regulation; Public Health, Government Policy; Provision and Effects of Welfare Programs, Gastrointestinal diseases, Respiratory Tract Infections, Diarrhea, Ethanol, Child, Preschool, Handwashing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1727 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABHS use
Arm Type
Experimental
Arm Description
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.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
ABHS use
Other Intervention Name(s)
Purell®, GOJO Industries, Dayton, Ohio
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Cases of Acute Diarrheal Disease Number of Cases of Acute Respiratory Infection
Time Frame
April - December 2008
Secondary Outcome Measure Information:
Title
Number of Adverse Events
Time Frame
April - December 2008

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan C Correa, MD
Organizational Affiliation
Fundación Santa Fe de Bogotá
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Diana Pinto, MD
Organizational Affiliation
Fedesarrollo, Pontificia Universidad Javeriana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundación Santa Fe de Bogotá
City
Bogotá
State/Province
D.c.
Country
Colombia

12. IPD Sharing Statement

Learn more about this trial

"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"

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