NCT00514670

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2007

Completed
Last Updated

August 10, 2007

Status Verified

August 1, 2007

First QC Date

August 9, 2007

Last Update Submit

August 9, 2007

Conditions

Respiratory InfectionsGastrointestinal Diseases

Keywords

Prevention of gastrointestinal and respiratory illness

Outcome Measures

Primary Outcomes (1)

  • Absenteeism rate due to gastrointestinal or respiratory illness during the study period.

    8 weeks

Secondary Outcomes (1)

  • Bacterial colony counts and the presence of selected viruses on classroom surfaces.

    8 weeks

Study Arms (2)

1

EXPERIMENTAL

Intervention classrooms received alcohol-based hand sanitizer and disinfecting wipes.

Other: Alcohol-based hand sanitizer & quaternary ammonium wipes

2

NO INTERVENTION

No hand sanitizer or disinfecting wipes were used.

Interventions

Alcohol-based hand sanitizer & quaternary ammonium wipesOTHER
1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Member of a designated elementary school classroom in the Avon school system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 18519460DERIVED

MeSH Terms

Conditions

Respiratory Tract InfectionsGastrointestinal Diseases

Interventions

Ethanol

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Thomas J Sandora, MD, MPH

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2007

First Posted

August 10, 2007

Study Start

March 1, 2006

Study Completion

May 1, 2006

Last Updated

August 10, 2007

Record last verified: 2007-08

Locations

US(1)