"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"

Not Applicable

Completed

• Conditions: Acute Diarrheal Disease; Acute Respiratory Infection
• Interventions: Other: ABHS use

• Registration Number: NCT00963391
• Lead Sponsor: Fundación Santa Fe de Bogota

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.

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-08
• Study First Submitted: 2009-08-20
• Study First Submitted QC: 2009-08-20
• Last Update Submitted: 2009-08-20
• Study First Posted: 2009-08-21
• Last Update Posted: 2009-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1727

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABHS use	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.

Primary Outcome Measures

Name	Time	Method
Number of Cases of Acute Diarrheal Disease Number of Cases of Acute Respiratory Infection	April - December 2008

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events	April - December 2008

Trial Locations

Locations (1)

Fundación Santa Fe de Bogotá; 🇨🇴 Bogotá, D.c., Colombia