Back to resultsA Randomized Controlled Trial of a School Disinfection and Hand Hygiene Program
Primary Purpose
Respiratory Infections, Gastrointestinal Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol-based hand sanitizer & quaternary ammonium wipes
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Infections focused on measuring Prevention of gastrointestinal and respiratory illness
Eligibility Criteria
Inclusion Criteria:
- Member of a designated elementary school classroom in the Avon school system
Sites / Locations
- Children's Hospital Boston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Intervention classrooms received alcohol-based hand sanitizer and disinfecting wipes.
No hand sanitizer or disinfecting wipes were used.
Outcomes
Primary Outcome Measures
Absenteeism rate due to gastrointestinal or respiratory illness during the study period.
Secondary Outcome Measures
Bacterial colony counts and the presence of selected viruses on classroom surfaces.
Full Information
NCT ID
NCT00514670
First Posted
August 9, 2007
Last Updated
August 9, 2007
Sponsor
Boston Children's Hospital
Collaborators
Study funds provided by The Clorox Company
1. Study Identification
Unique Protocol Identification Number
NCT00514670
Brief Title
A Randomized Controlled Trial of a School Disinfection and Hand Hygiene Program
Official Title
A Randomized Controlled Trial of a School Disinfection and Hand Hygiene Program
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boston Children's Hospital
Collaborators
Study funds provided by The Clorox Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the trial is to assess the impact of a disinfection and hand hygiene program on absenteeism in elementary school classrooms. Students in intervention classrooms will use alcohol-based hand sanitizers at school, and their classrooms will be disinfected using quaternary ammonium wipes. We hypothesize that the use of disinfectants and hand hygiene products in elementary school classrooms will reduce absenteeism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Infections, Gastrointestinal Diseases
Keywords
Prevention of gastrointestinal and respiratory illness
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
285 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Intervention classrooms received alcohol-based hand sanitizer and disinfecting wipes.
Arm Title
2
Arm Type
No Intervention
Arm Description
No hand sanitizer or disinfecting wipes were used.
Intervention Type
Other
Intervention Name(s)
Alcohol-based hand sanitizer & quaternary ammonium wipes
Primary Outcome Measure Information:
Title
Absenteeism rate due to gastrointestinal or respiratory illness during the study period.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Bacterial colony counts and the presence of selected viruses on classroom surfaces.
Time Frame
8 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Member of a designated elementary school classroom in the Avon school system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Sandora, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18519460
Citation
Sandora TJ, Shih MC, Goldmann DA. Reducing absenteeism from gastrointestinal and respiratory illness in elementary school students: a randomized, controlled trial of an infection-control intervention. Pediatrics. 2008 Jun;121(6):e1555-62. doi: 10.1542/peds.2007-2597.
Results Reference
derived
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A Randomized Controlled Trial of a School Disinfection and Hand Hygiene Program
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