"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:
Fundación Santa Fe de Bogota
ClinicalTrials.gov Identifier:
NCT00963391
First received: August 20, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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).


Condition Intervention
Acute Diarrheal Disease
Acute Respiratory Infection
Other: ABHS use

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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"

Resource links provided by NLM:


Further study details as provided by Fundación Santa Fe de Bogota:

Primary Outcome Measures:
  • Number of Cases of Acute Diarrheal Disease Number of Cases of Acute Respiratory Infection [ Time Frame: April - December 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Adverse Events [ Time Frame: April - December 2008 ] [ Designated as safety issue: Yes ]

Enrollment: 1727
Study Start Date: February 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.

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

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963391

Locations
Colombia
Fundación Santa Fe de Bogotá
Bogotá, D.c., Colombia
Sponsors and Collaborators
Fundación Santa Fe de Bogota
Fedesarrollo
Pontificia Universidad Javeriana
Global Development Network
Investigators
Principal Investigator: Juan C Correa, MD Fundación Santa Fe de Bogotá
Principal Investigator: Diana Pinto, MD Fedesarrollo, Pontificia Universidad Javeriana
  More Information

No publications provided

Responsible Party: Juan C. Correa/Director of the Community Health Division, Fundación Santa Fe de Bogotá
ClinicalTrials.gov Identifier: NCT00963391     History of Changes
Other Study ID Numbers: TMPCOL298
Study First Received: August 20, 2009
Last Updated: August 20, 2009
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Fundación Santa Fe de Bogota:
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

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Hand Sanitizers
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants

ClinicalTrials.gov processed this record on August 28, 2014