Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections
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|ClinicalTrials.gov Identifier: NCT01728090|
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : November 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Upper Respiratory Infections Influenza Common Cold||Other: hand sanitizer||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1640 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Experimental: Hand sanitizer
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.
Other: hand sanitizer
alcohol-based, hydroalcoholic gel
Other Name: ALCO ALOE GEL
No Intervention: Control
No hand sanitizer or educational programme were used
- School absenteeism rate caused by upper respiratory infection [ Time Frame: One academic year (eight months follow-up) ]
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.
- Average duration of absence [ Time Frame: One academic year (eight months follow-up) ]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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728090
|Principal Investigator:||Ernestina Azor, MD, PhD||Department of Health of Andalusia|