"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"

Acute Respiratory Infection Clinical 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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963391
• Other study ID #: TMPCOL298
• Status: Completed
• Phase: N/A
• First received: August 20, 2009
• Last updated: August 20, 2009
• Start date: February 2008
• Est. completion date: December 2008

Study information

• Verified date: August 2009
• Source: Fundación Santa Fe de Bogota
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1727
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 5 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Diarrheal Disease
• Acute Respiratory Infection
• Communicable Diseases
• Infection
• Respiratory Tract Infections

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Colombia	Fundación Santa Fe de Bogotá	Bogotá	D.c.

Sponsors (4)

Lead Sponsor	Collaborator
Fundación Santa Fe de Bogota	Fedesarrollo, Global Development Network, Pontificia Universidad Javeriana

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Cases of Acute Diarrheal Disease Number of Cases of Acute Respiratory Infection		April - December 2008	No
Secondary	Number of Adverse Events		April - December 2008	Yes