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Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections

Primary Purpose

Upper Respiratory Infections, Influenza, Common Cold

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
hand sanitizer
Sponsored by
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Upper Respiratory Infections focused on measuring handwashing, hand sanitizer, absenteeism, school age children, preschool children

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • School children between the ages of 4 and 12 years old, enrolled in the above mentioned public schools,
  • The parents/tutors signed an agreement after being informed of its content.

Exclusion criteria:

  • Children with absenteeism due to a different cause from upper respiratory infections
  • Children with chronic illnesses that could affect their likelihood of contracting an infection or the duration of their period of absence from school
  • Children whose parents did not authorise their participation in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Hand sanitizer

    Control

    Arm Description

    Intervention classrooms received alcohol-based hand sanitizer and a programme educational. Characteristics of the hydroalcoholic gel (ALCO ALOE GEL): chlorhexidine digluconate at 20% solution, phenoxyethanol 1%, benzalkonium chloride 0.%. aloe Barbadensis 5%, Renat ethyl alcohol 70%, excipients c.s.p. 100 ml. Alcohol of between 65 - 70% degrees, pondus Hydrogenium (pH) = 7-7,5.

    No hand sanitizer or educational programme were used

    Outcomes

    Primary Outcome Measures

    School absenteeism rate caused by upper respiratory infection
    The incidence rate of respiratory infections was calculated dividing the number of episodes respiratory by the number of pupils during the period of this study who were susceptible to the infection. Incidence rate ratio indicates (IRR): the ratio between incidence rate in both study groups.

    Secondary Outcome Measures

    Average duration of absence
    The average duration of absence per child was calculated dividing the number of absence days due to respiratory infection by the total number of children during that period.

    Full Information

    First Posted
    November 13, 2012
    Last Updated
    November 16, 2012
    Sponsor
    Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
    Collaborators
    Ministry of Health, Spain
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01728090
    Brief Title
    Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections
    Official Title
    Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    May 2010 (Actual)
    Study Completion Date
    May 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
    Collaborators
    Ministry of Health, Spain

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of the study was to assess the effectiveness of a hand-washing programme using hand sanitizer in the prevention of school absenteeism due to upper respiratory infections. Students in intervention classrooms used hand sanitizers at schools and a programme educational on hand hygiene. The investigators hypothesize that the use de hand sanitizers in elementary school will reduce absenteeism due to upper respiratory infections.
    Detailed Description
    School absenteeism due to respiratory infections is one of the greatest problems in schools. Its high incidence and easy transmission among pupils have a great impact requiring a vast number of medical visits, hospitalisations, use of antibiotic and antipyretic treatments, symptomatic medication, etc. besides being a cause for school absenteeism and time off work for parents. Hand- washing is the most important and effective measure to prevent the transmission of infections. The investigators evaluated the effectiveness of a hand-washing programme using hand sanitizer in the prevention of school absenteeism due to upper respiratory infections. A cluster randomised, controlled and open study of 2 cohorts of primary school children between the ages of 4 and 12, attending 5 Public Schools in a geographic area of the Almería province (Spain). This study was carried out throughout the 8 months of an academic year (October 2009 to May 2010). The experimental group washed their hands with soap and water, complemented with hand sanitizer, while the control group followed usual hand washing. The parents of both groups completed the survey on sociodemographic characteristics and questions about hand hygiene referred to when and how their children wash their hands Progenitors of children who were absent from school collected upper respiratory infections symptoms and handed in the completed form to the teacher. One Research assistant collected the absence sheets of the participating classes weekly, telephoned the parents of absent children to enquire about the cause of their absence, visited the classrooms and collaborated with the teachers in hand hygiene related activities.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Upper Respiratory Infections, Influenza, Common Cold
    Keywords
    handwashing, hand sanitizer, absenteeism, school age children, preschool children

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1640 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hand sanitizer
    Arm Type
    Experimental
    Arm Description
    Intervention classrooms received alcohol-based hand sanitizer and a programme educational. Characteristics of the hydroalcoholic gel (ALCO ALOE GEL): chlorhexidine digluconate at 20% solution, phenoxyethanol 1%, benzalkonium chloride 0.%. aloe Barbadensis 5%, Renat ethyl alcohol 70%, excipients c.s.p. 100 ml. Alcohol of between 65 - 70% degrees, pondus Hydrogenium (pH) = 7-7,5.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    No hand sanitizer or educational programme were used
    Intervention Type
    Other
    Intervention Name(s)
    hand sanitizer
    Other Intervention Name(s)
    ALCO ALOE GEL
    Intervention Description
    alcohol-based, hydroalcoholic gel
    Primary Outcome Measure Information:
    Title
    School absenteeism rate caused by upper respiratory infection
    Description
    The incidence rate of respiratory infections was calculated dividing the number of episodes respiratory by the number of pupils during the period of this study who were susceptible to the infection. Incidence rate ratio indicates (IRR): the ratio between incidence rate in both study groups.
    Time Frame
    One academic year (eight months follow-up)
    Secondary Outcome Measure Information:
    Title
    Average duration of absence
    Description
    The average duration of absence per child was calculated dividing the number of absence days due to respiratory infection by the total number of children during that period.
    Time Frame
    One academic year (eight months follow-up)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: School children between the ages of 4 and 12 years old, enrolled in the above mentioned public schools, The parents/tutors signed an agreement after being informed of its content. Exclusion criteria: Children with absenteeism due to a different cause from upper respiratory infections Children with chronic illnesses that could affect their likelihood of contracting an infection or the duration of their period of absence from school Children whose parents did not authorise their participation in the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ernestina Azor, MD, PhD
    Organizational Affiliation
    Department of Health of Andalusia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections

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