Clinical trial NCT00963391: "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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Fundación Santa Fe de Bogota
Sponsor class: OTHER
Collaborators: name: Fedesarrollo
name: Pontificia Universidad Javeriana
name: Global Development Network
First posted: 2009-08-21
Enrollment: 1727
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Cases of Acute Diarrheal Disease Number of Cases of Acute Respiratory Infection
timeFrame: April - December 2008
Secondary outcomes:
measure: Number of Adverse Events
timeFrame: April - December 2008
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Fundación Santa Fe de Bogotá
state: D.c.
Study officials:
affiliation: Fundación Santa Fe de Bogotá
name: Juan C Correa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fedesarrollo, Pontificia Universidad Javeriana
name: Diana Pinto, MD
role: PRINCIPAL_INVESTIGATOR
References: