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

NCT01728090 | Completed Phase 4 DMC

• 1 other identifier: PI 0388/2008
• Study Type: interventional
• Target: 1,640
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Upper Respiratory Infections; Influenza; Common Cold

Keywords

handwashing; hand sanitizer; absenteeism; school age children; preschool children

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Average duration of absence

  One academic year (eight months follow-up)

Study Arms (2)

Hand sanitizer

EXPERIMENTAL

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

Control

NO INTERVENTION

No hand sanitizer or educational programme were used

Interventions

hand sanitizer OTHER

alcohol-based, hydroalcoholic gel

Also known as: ALCO ALOE GEL

Hand sanitizer

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental: lead
• Ministry of Health, Spain: collaborator

MeSH Terms

Conditions

Respiratory Tract Infections; Influenza, Human; Common Cold

Interventions

Hand Sanitizers

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Picornaviridae Infections

Intervention Hierarchy (Ancestors)

Anti-Infective Agents, Local; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Disinfectants; Specialty Uses of Chemicals

Study Officials

• Ernestina Azor, MD, PhD

  Department of Health of Andalusia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 16, 2012
• Study Start: October 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 19, 2012

Record last verified: 2012-11