"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"
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Diarrheal Disease
- Sponsor
- Fundación Santa Fe de Bogota
- Enrollment
- 1727
- Locations
- 1
- Primary Endpoint
- Number of Cases of Acute Diarrheal Disease Number of Cases of Acute Respiratory Infection
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Number of Cases of Acute Diarrheal Disease Number of Cases of Acute Respiratory Infection
Time Frame: April - December 2008
Secondary Outcomes
- Number of Adverse Events(April - December 2008)