"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"

This study has been completed.
Sponsor:
Collaborators:
Fedesarrollo
Pontificia Universidad Javeriana
Global Development Network
Information provided by:
Fundacion Santafe de Bogota
ClinicalTrials.gov Identifier:
NCT00963391
First received: August 20, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted

August 20, 2009
August 20, 2009
February 2008
December 2008   (final data collection date for primary outcome measure)
Number of Cases of Acute Diarrheal Disease Number of Cases of Acute Respiratory Infection [ Time Frame: April - December 2008 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Number of Adverse Events [ Time Frame: April - December 2008 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
"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"
"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"

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Acute Diarrheal Disease
  • Acute Respiratory Infection
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.

Other Name: Purell®, GOJO Industries, Dayton, Ohio
  • Experimental: 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.
    Intervention: Other: ABHS use
  • No Intervention: 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1727
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
1 Year to 5 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Colombia
 
NCT00963391
TMPCOL298
No
Juan C. Correa/Director of the Community Health Division, Fundación Santa Fe de Bogotá
Fundacion Santafe de Bogota
  • Fedesarrollo
  • Pontificia Universidad Javeriana
  • Global Development Network
Principal Investigator: Juan C Correa, MD Fundación Santa Fe de Bogotá
Principal Investigator: Diana Pinto, MD Fedesarrollo, Pontificia Universidad Javeriana
Fundacion Santafe de Bogota
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP