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

Primary Purpose

Respiratory Tract Infections, Gastroenteritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hand sanitizer
liquid soap
Sponsored by
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Tract Infections focused on measuring Respiratory Tract Infections, gastroenteritis, hand sanitizer, handwashing, day care

Eligibility Criteria

4 Months - 3 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Hand sanitizer group

    Liquid soap group

    Control group

    Arm Description

    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.

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

    No hand sanitizer or educational program were used.

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

    Antibiotic prescribing for respiratory infections
    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
    The direct costs of episodes due to respiratory and gastrointestinal infections were measured

    Full Information

    First Posted
    September 15, 2017
    Last Updated
    September 26, 2017
    Sponsor
    Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
    Collaborators
    Ministry of Health, Spain
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03294772
    Brief Title
    Impact of a Multifactorial Program of Hand Hygiene on Infections in Children Attending in Day-care Centres
    Official Title
    Socio-health Impact of a Multifactorial Program of Hand Hygiene on Respiratory and Gastrointestinal Infections in Children Attending in Day-care Centres
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2013 (Actual)
    Primary Completion Date
    June 30, 2014 (Actual)
    Study Completion Date
    December 30, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
    Collaborators
    Ministry of Health, Spain

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Tract Infections, Gastroenteritis
    Keywords
    Respiratory Tract Infections, gastroenteritis, hand sanitizer, handwashing, day care

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    911 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hand sanitizer group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Liquid soap group
    Arm Type
    Experimental
    Arm Description
    DCCs received soap and program educational. The liquid soaps used for handwashing in this study did not contain specific antibacterial component, ph= 5.5.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    No hand sanitizer or educational program were used.
    Intervention Type
    Other
    Intervention Name(s)
    hand sanitizer
    Other Intervention Name(s)
    educational intervention
    Intervention Description
    DCCs received alcohol-based hand sanitizer and a program educational.
    Intervention Type
    Other
    Intervention Name(s)
    liquid soap
    Other Intervention Name(s)
    educational intervention
    Intervention Description
    DCCs received liquid soap and a program educational.
    Primary Outcome Measure Information:
    Title
    the episodes due to respiratory tract infections
    Description
    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
    Time Frame
    8 moth
    Title
    The episodes due to gastroenteritis
    Description
    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
    Time Frame
    8 month
    Secondary Outcome Measure Information:
    Title
    Antibiotic prescribing for respiratory infections
    Description
    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
    Time Frame
    8 month
    Title
    The direct cost of respiratory and gastrointestinal infections
    Description
    The direct costs of episodes due to respiratory and gastrointestinal infections were measured
    Time Frame
    8 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Months
    Maximum Age & Unit of Time
    3 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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
    IPD Sharing Time Frame
    Currently the database is available, we are waiting for statistical analysis
    Citations:
    PubMed Identifier
    34814193
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    30297500
    Citation
    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.
    Results Reference
    derived

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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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