"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"

NCT ID: NCT00963391

Last Updated: 2009-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1727 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2008-12-31

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.

Conditions

Acute Diarrheal Disease; Acute Respiratory Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ABHS use

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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). 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.

Intervention Type: OTHER

Other Intervention Names

Purell®, GOJO Industries, Dayton, Ohio

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fedesarrollo

UNKNOWN

Sponsor Role: collaborator

Pontificia Universidad Javeriana

OTHER

Sponsor Role: collaborator

Global Development Network

UNKNOWN

Sponsor Role: collaborator

Fundación Santa Fe de Bogota

OTHER

Sponsor Role: lead

Responsible Party

Fundación Santa Fe de Bogotá

Principal Investigators

Juan C Correa, MD

Role: PRINCIPAL_INVESTIGATOR

Fundación Santa Fe de Bogotá

Diana Pinto, MD

Role: PRINCIPAL_INVESTIGATOR

Fedesarrollo, Pontificia Universidad Javeriana

Locations

Fundación Santa Fe de Bogotá

Bogotá, D.C., Colombia

Countries

Colombia

Other Identifiers

TMPCOL298

Identifier Type: -

Identifier Source: org_study_id