<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03294772</url>
  </required_header>
  <id_info>
    <org_study_id>FIBAO</org_study_id>
    <nct_id>NCT03294772</nct_id>
  </id_info>
  <brief_title>Impact of a Multifactorial Program of Hand Hygiene on Infections in Children Attending in Day-care Centres</brief_title>
  <official_title>Socio-health Impact of a Multifactorial Program of Hand Hygiene on Respiratory and Gastrointestinal Infections in Children Attending in Day-care Centres</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Spain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is well known that attending Day Care Centres (DCCs) can lead to an increase in the&#xD;
      frequency of infections, due to the high incidence at this age and also the ease of&#xD;
      transmission among children. This high incidence respiratory tract infections (RTIs) and&#xD;
      acute gastroenteritis can also have a significant impact on the cost of health care systems,&#xD;
      increasing the number of medical visits, hospitalizations and prescribing medications as&#xD;
      symptomatic drugs or unnecessary antibiotics in some cases.The aim of the study was to&#xD;
      determine whether a multifactorial hand-hygiene program (handwashing with soap and water vs&#xD;
      hand sanitizer vs control group) reduce episodes due to RTIs and gastroenteritis in children&#xD;
      attending DCCs. In addition, analyze the cost-effectiveness of these interventions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, controlled, and open study of 3 cohorts of families with children attending to&#xD;
      DCCs, between the ages of 0 and 3, attending 25 DCC (911 children) in Almeria (Spain) was&#xD;
      designed. This study was carried out over the course of 8 months (November 2013 to June&#xD;
      2014). A group of DCCs/families will perform hand hygiene with soap and water (SWG), another&#xD;
      group with hand sanitizer gel (HSG) and a control group (CG) practiced usual handwashing&#xD;
      techniques.&#xD;
&#xD;
      Intervention: The families and DCCs staff randomly assigned to HSG and SWG attended&#xD;
      handwashing workshops of 2-hour duration. These took place one month before the beginning of&#xD;
      the study. Workshop content included education about the most frequent infections in DCCs,&#xD;
      their transmission, prevention, treatment, instructions on how and when hands should be&#xD;
      washed, use of hand sanitizers and possible side effects in the HSG. Every 2 weeks, the&#xD;
      research assistant and the teachers (staff) performed activities such as stories, songs and&#xD;
      posters in the classroom, which are linked to hand hygiene and infection's transmission. In&#xD;
      the Children/families in the HSG and SWG were instructed by the researchers, teachers, and&#xD;
      research assistant to maintain the usual handwashing procedure after going to the toilet and&#xD;
      when their hands were visibly dirty. They also were told to use the hand sanitizer and&#xD;
      handwashing with water and liquid soap correctly in the following circumstances: after coming&#xD;
      into the classroom; before and after lunch; after playing outside; when they went home; and&#xD;
      after coughing; sneezing; or blowing their noses; after diapering.&#xD;
&#xD;
      Parents of the three groups completed the survey on sociodemographic characteristics and&#xD;
      questions about hand hygiene referred to when and how their children wash their hands.&#xD;
      Progenitors of children whit episodes due to RTIs and gastroenteritis collected the symptoms&#xD;
      and handed in the completed form to the teacher. A research assistant collected the absence&#xD;
      sheets of the participating classes weekly, called the parents of absent children to enquire&#xD;
      about the cause of their absence, visited the classrooms and collaborated with the teachers&#xD;
      in activities related to the hygiene of hands.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2013</start_date>
  <completion_date type="Actual">December 30, 2015</completion_date>
  <primary_completion_date type="Actual">June 30, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the episodes due to respiratory tract infections</measure>
    <time_frame>8 moth</time_frame>
    <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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The episodes due to gastroenteritis</measure>
    <time_frame>8 month</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antibiotic prescribing for respiratory infections</measure>
    <time_frame>8 month</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The direct cost of respiratory and gastrointestinal infections</measure>
    <time_frame>8 month</time_frame>
    <description>The direct costs of episodes due to respiratory and gastrointestinal infections were measured</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">911</enrollment>
  <condition>Respiratory Tract Infections</condition>
  <condition>Gastroenteritis</condition>
  <arm_group>
    <arm_group_label>Hand sanitizer group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liquid soap group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No hand sanitizer or educational program were used.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>hand sanitizer</intervention_name>
    <description>DCCs received alcohol-based hand sanitizer and a program educational.</description>
    <arm_group_label>Hand sanitizer group</arm_group_label>
    <other_name>educational intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>liquid soap</intervention_name>
    <description>DCCs received liquid soap and a program educational.</description>
    <arm_group_label>Liquid soap group</arm_group_label>
    <other_name>educational intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Children between 0 and 3 years old enrolled in the aforementioned DCCs,&#xD;
        attended the DCCs for at least 15 hours per week and whose parents/guardians had signed an&#xD;
        informed consent document were included.&#xD;
&#xD;
        Exclusion Criteria: Children whit chronic illnesses or medication that could affect their&#xD;
        likelihood of contracting an infection. Families who used hydroalcoholic gel prior to the&#xD;
        start of the study and/or antiseptic soaps in the control group.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Months</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>September 26, 2017</last_update_submitted>
  <last_update_submitted_qc>September 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental</investigator_affiliation>
    <investigator_full_name>Ernestina Azor Martínez</investigator_full_name>
    <investigator_title>Principal Investigador</investigator_title>
  </responsible_party>
  <keyword>Respiratory Tract Infections</keyword>
  <keyword>gastroenteritis</keyword>
  <keyword>hand sanitizer</keyword>
  <keyword>handwashing</keyword>
  <keyword>day care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Gastroenteritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hand Sanitizers</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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_description>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Currently the database is available, we are waiting for statistical analysis</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03294772
org study id: FIBAO
nct id: NCT03294772
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: the episodes due to respiratory tract infections
time frame: 8 moth
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
measure: The episodes due to gastroenteritis
time frame: 8 month
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
measure: Antibiotic prescribing for respiratory infections
time frame: 8 month
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
measure: The direct cost of respiratory and gastrointestinal infections
time frame: 8 month
description: The direct costs of episodes due to respiratory and gastrointestinal infections were measured
arm group label: Hand sanitizer group
arm group type: Experimental
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 group label: Liquid soap group
arm group type: Experimental
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 group label: Control group
arm group type: No Intervention
description: No hand sanitizer or educational program were used.
intervention type: Other
intervention name: hand sanitizer
description: DCCs received alcohol-based hand sanitizer and a program educational.
arm group label: Hand sanitizer group
other name: educational intervention
intervention type: Other
intervention name: liquid soap
description: DCCs received liquid soap and a program educational.
arm group label: Liquid soap group
other name: educational intervention
criteria: 
gender: All
minimum age: 4 Months
maximum age: 3 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
investigator full name: Ernestina Azor Martínez
investigator title: Principal Investigador
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Respiratory Tract Infections
mesh term: Gastroenteritis
mesh term: Hand Sanitizers
sharing ipd: Yes
ipd 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 info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Currently the database is available, we are waiting for statistical analysis