"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"
Condition: Acute Diarrheal Disease; Acute Respiratory Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional

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).
    

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.
    

Intervention name(s): ABHS use
Intervention type(s): Other
Intervention description(s): 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 intervention name(s): Purell®, GOJO Industries, Dayton, Ohio
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: 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