"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"
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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" |
- Number of Cases of Acute Diarrheal Disease Number of Cases of Acute Respiratory Infection [ Time Frame: April - December 2008 ] [ Designated as safety issue: No ]
- 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 |
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| Colombia | |
| Fundación Santa Fe de Bogotá | |
| Bogotá, D.c., Colombia | |
| 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 Fundacion Santafe 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 Diarrhea Infection |
Respiratory Tract Diseases Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013