Impact of a Multifactorial Program of Hand Hygiene on Infections in Children Attending in Day-care Centres

NCT03294772 | Completed DMC

• 1 other identifier: FIBAO
• Study Type: interventional
• Target: 911
• Locations: 0 countries
• Sites: N/A

Brief Summary

It is well known that attending Day Care Centres (DCCs) can lead to an increase in the frequency of infections, due to the high incidence at this age and also the ease of transmission among children. This high incidence respiratory tract infections (RTIs) and acute gastroenteritis can also have a significant impact on the cost of health care systems, increasing the number of medical visits, hospitalizations and prescribing medications as symptomatic drugs or unnecessary antibiotics in some cases.The aim of the study was to determine whether a multifactorial hand-hygiene program (handwashing with soap and water vs hand sanitizer vs control group) reduce episodes due to RTIs and gastroenteritis in children attending DCCs. In addition, analyze the cost-effectiveness of these interventions.

Conditions

Respiratory Tract Infections; Gastroenteritis

Keywords

Respiratory Tract Infections; gastroenteritis; hand sanitizer; handwashing; day care

Outcome Measures

Primary Outcomes (2)

• the episodes due to respiratory tract infections

  The incidence rate of respiratory tract infections was calculated dividing the number of episodes due to tract respiratory infection by the number of pupils during the period of this study. Incidence rate ratio indicates (IRR): the ratio between incidence rate in 3 study groups

  8 moth

• The episodes due to gastroenteritis

  The incidence rate of gastroenteritis was calculated dividing the number of episodes due to gastroenteritis by the number of pupils during the period of this study. Incidence rate ratio indicates (IRR): the ratio between incidence rate in 3 study groups

  8 month

Secondary Outcomes (2)

• Antibiotic prescribing for respiratory infections

  8 month

• The direct cost of respiratory and gastrointestinal infections

  8 month

Study Arms (3)

Hand sanitizer group

EXPERIMENTAL

DCCs received alcohol-based hand sanitizer and a program educational. Characteristics of the hydroalcoholic gel (Alco aloe gel): chlorhexidine digluconate at 0.2% solution, phenoxyethanol 1%, benzalkonium chloride 0.1%. aloe barbadensis 5%, ethyl alcohol 70%, excipients c.s.p. 100 ml. Alcohol of between 70%, ph = 7-7,5.

Other: hand sanitizer

Liquid soap group

EXPERIMENTAL

DCCs received soap and program educational. The liquid soaps used for handwashing in this study did not contain specific antibacterial component, ph= 5.5.

Other: liquid soap

Control group

NO INTERVENTION

No hand sanitizer or educational program were used.

Interventions

hand sanitizer OTHER

DCCs received alcohol-based hand sanitizer and a program educational.

Also known as: educational intervention

Hand sanitizer group

liquid soap OTHER

DCCs received liquid soap and a program educational.

Also known as: educational intervention

Liquid soap group

Eligibility Criteria

• Age: 4 Months - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

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

Related Publications (2)

• Azor-Martinez E, Garcia-Mochon L, Lopez-Lacort M, Strizzi JM, Munoz-Vico FJ, Jimenez-Lorente CP, Fernandez-Campos MA, Bueno-Rebollo C, Del Castillo-Aguas G, Balaguer-Martinez JV, Gimenez-Sanchez F. Child Care Center Hand Hygiene Programs' Cost-Effectiveness in Preventing Respiratory Infections. Pediatrics. 2021 Dec 1;148(6):e2021052496. doi: 10.1542/peds.2021-052496.

  PMID: 34814193 DERIVED

• Azor-Martinez E, Yui-Hifume R, Munoz-Vico FJ, Jimenez-Noguera E, Strizzi JM, Martinez-Martinez I, Garcia-Fernandez L, Seijas-Vazquez ML, Torres-Alegre P, Fernandez-Campos MA, Gimenez-Sanchez F. Effectiveness of a Hand Hygiene Program at Child Care Centers: A Cluster Randomized Trial. Pediatrics. 2018 Nov;142(5):e20181245. doi: 10.1542/peds.2018-1245. Epub 2018 Oct 8.

  PMID: 30297500 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections; Gastroenteritis

Interventions

Hand Sanitizers; Early Intervention, Educational

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents, Local; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Disinfectants; Specialty Uses of Chemicals; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigador

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 27, 2017
• Study Start: November 1, 2013
• Primary Completion: June 30, 2014
• Study Completion: December 30, 2015
• Last Updated: September 27, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Currently the database is available, we are waiting for statistical analysis