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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728090
• Other study ID #: PI 0388/2008
• Status: Completed
• Phase: Phase 4
• First received: November 13, 2012
• Last updated: November 16, 2012
• Start date: October 2009
• Est. completion date: May 2010

Study information

• Verified date: November 2012
• Source: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1640
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Common Cold
• Infection
• Influenza
• Respiratory Tract Infections
• Upper Respiratory Infections

Intervention

Other:
• hand sanitizer
alcohol-based, hydroalcoholic gel

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental	Ministry of Health, Spain

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One academic year (eight months follow-up)	No
Secondary	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.	One academic year (eight months follow-up)	No