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

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ClinicalTrials.gov Identifier: NCT03294772
Recruitment Status : Completed
First Posted : September 27, 2017
Last Update Posted : September 27, 2017
Sponsor:
Collaborator:
Ministry of Health, Spain
Information provided by (Responsible Party):
Ernestina Azor Martínez, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

Tracking Information
First Submitted Date  ICMJE September 15, 2017
First Posted Date  ICMJE September 27, 2017
Last Update Posted Date September 27, 2017
Actual Study Start Date  ICMJE November 1, 2013
Actual Primary Completion Date June 30, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2017)
  • the episodes due to respiratory tract infections [ Time Frame: 8 moth ]
    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
  • The episodes due to gastroenteritis [ Time Frame: 8 month ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2017)
  • Antibiotic prescribing for respiratory infections [ Time Frame: 8 month ]
    In this study presence or absence of at least 1 antibiotic prescription for each new episode of the RTIs (upper and low RTIs, otitis, amygdalitis, and bronchitis) was collected during the study period
  • The direct cost of respiratory and gastrointestinal infections [ Time Frame: 8 month ]
    The direct costs of episodes due to respiratory and gastrointestinal infections were measured
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of a Multifactorial Program of Hand Hygiene on Infections in Children Attending in Day-care Centres
Official Title  ICMJE Socio-health Impact of a Multifactorial Program of Hand Hygiene on Respiratory and Gastrointestinal Infections in Children Attending in Day-care Centres
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.
Detailed Description

A randomized, controlled, and open study of 3 cohorts of families with children attending to DCCs, between the ages of 0 and 3, attending 25 DCC (911 children) in Almeria (Spain) was designed. This study was carried out over the course of 8 months (November 2013 to June 2014). A group of DCCs/families will perform hand hygiene with soap and water (SWG), another group with hand sanitizer gel (HSG) and a control group (CG) practiced usual handwashing techniques.

Intervention: The families and DCCs staff randomly assigned to HSG and SWG attended handwashing workshops of 2-hour duration. These took place one month before the beginning of the study. Workshop content included education about the most frequent infections in DCCs, their transmission, prevention, treatment, instructions on how and when hands should be washed, use of hand sanitizers and possible side effects in the HSG. Every 2 weeks, the research assistant and the teachers (staff) performed activities such as stories, songs and posters in the classroom, which are linked to hand hygiene and infection's transmission. In the Children/families in the HSG and SWG were instructed by the researchers, teachers, and research assistant to maintain the usual handwashing procedure after going to the toilet and when their hands were visibly dirty. They also were told to use the hand sanitizer and handwashing with water and liquid soap correctly in the following circumstances: after coming into the classroom; before and after lunch; after playing outside; when they went home; and after coughing; sneezing; or blowing their noses; after diapering.

Parents of the three 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 whit episodes due to RTIs and gastroenteritis collected the symptoms and handed in the completed form to the teacher. A research assistant collected the absence sheets of the participating classes weekly, called the parents of absent children to enquire about the cause of their absence, visited the classrooms and collaborated with the teachers in activities related to the hygiene of hands.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Respiratory Tract Infections
  • Gastroenteritis
Intervention  ICMJE
  • Other: hand sanitizer
    DCCs received alcohol-based hand sanitizer and a program educational.
    Other Name: educational intervention
  • Other: liquid soap
    DCCs received liquid soap and a program educational.
    Other Name: educational intervention
Study Arms  ICMJE
  • Experimental: Hand sanitizer group
    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.
    Intervention: Other: hand sanitizer
  • Experimental: Liquid soap group
    DCCs received soap and program educational. The liquid soaps used for handwashing in this study did not contain specific antibacterial component, ph= 5.5.
    Intervention: Other: liquid soap
  • No Intervention: Control group
    No hand sanitizer or educational program were used.
Publications * Azor-Martinez E, Yui-Hifume R, Muñoz-Vico FJ, Jimenez-Noguera E, Strizzi JM, Martinez-Martinez I, Garcia-Fernandez L, Seijas-Vazquez ML, Torres-Alegre P, Fernández-Campos MA, Gimenez-Sanchez F. Effectiveness of a Hand Hygiene Program at Child Care Centers: A Cluster Randomized Trial. Pediatrics. 2018 Nov;142(5). pii: e20181245. doi: 10.1542/peds.2018-1245. Epub 2018 Oct 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2017)
911
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2015
Actual Primary Completion Date June 30, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Children between 0 and 3 years old enrolled in the aforementioned DCCs, attended the DCCs for at least 15 hours per week and whose parents/guardians had signed an informed consent document were included.

Exclusion Criteria: Children whit chronic illnesses or medication that could affect their likelihood of contracting an infection. Families who used hydroalcoholic gel prior to the start of the study and/or antiseptic soaps in the control group.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Months to 3 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03294772
Other Study ID Numbers  ICMJE FIBAO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The researchers in this study have participated in: the study protocol, informed consent form, workshops on hand hygiene and transmission of infections and how to prevent it. They will also share statistical Analysis Plan and clinical study report
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Currently the database is available, we are waiting for statistical analysis
Responsible Party Ernestina Azor Martínez, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Study Sponsor  ICMJE Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Collaborators  ICMJE Ministry of Health, Spain
Investigators  ICMJE Not Provided
PRS Account Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP