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NCT Number: 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"

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).

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Key information

Conditions

Acute Diarrheal Disease Acute Respiratory Infection Diarrhea Digestive System Diseases Gastrointestinal Diseases Infections Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Digestive

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundación Santa Fe de Bogotá

Bogotá, D.C., Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABHS use

Other

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 names: Purell®, GOJO Industries, Dayton, Ohio

Primary outcomes

  1. Number of Cases of Acute Diarrheal Disease Number of Cases of Acute Respiratory Infection

    Time frame: April - December 2008

Secondary outcomes

  1. Number of Adverse Events

    Time frame: April - December 2008

Sponsors and collaborators

Lead sponsor

Fundación Santa Fe de Bogota

Other

Collaborators

  • Fedesarrollo
  • Global Development Network
  • Pontificia Universidad Javeriana

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 21, 2009
Registry last updated
Aug 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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