<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/NCT03755635</url>
  </required_header>
  <id_info>
    <org_study_id>UM ID: 892333</org_study_id>
    <nct_id>NCT03755635</nct_id>
  </id_info>
  <brief_title>Neonatal Sepsis at Neonatal Intensive Care Units in Ghana</brief_title>
  <official_title>Neonatal Sepsis at Neonatal Intensive Care Units of Two Major Referral Hospitals in Ghana</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stephanie Bjerrum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Korle-Bu Teaching Hospital, Accra, Ghana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Ghana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <has_dmc>No</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>
      Background: Neonatal sepsis is a major contributor to global under five mortality. In&#xD;
      developing countries a major proportion of neonatal sepsis is thought to emanate from the&#xD;
      healthcare setting, due to challenges in infection prevention practices.&#xD;
&#xD;
      Aim: To study the epidemiology of neonatal sepsis and evaluate the effect of multimodal&#xD;
      infection control interventions on the incidence of neonatal sepsis; and colonization by&#xD;
      multidrug resistant Gram negative bacteria (MDRGNB).&#xD;
&#xD;
      Methods: A controlled before and after interventional trial comprising a 7 month pre-&#xD;
      intervention phase, 5 month intervention phase and 7 month post-intervention phase. Neonates&#xD;
      admitted at the Neonatal Intensive Care Unit (NICU) at Korle-Bu Teaching Hospital (KBTH) will&#xD;
      be enrolled prospectively and followed up for diagnosis of sepsis and outcome of admission.&#xD;
      This will be used to describe the epidemiology of neonatal sepsis. Swabs will be collected&#xD;
      from a subpopulation of included neonates at intervention site (KBTH) and control site (37&#xD;
      Military Hospital) NICUs to assess colonization of neonates with MDRGNB. Environmental swabs&#xD;
      will be collected from surfaces at the NICU to assess MDRGNB contamination of the&#xD;
      environment. The intervention comprises infection prevention strategies including&#xD;
      implementation of the WHO multimodal hand hygiene strategy. The primary endpoint is incidence&#xD;
      of neonatal sepsis.&#xD;
&#xD;
      Expected Outcome: This study will contribute to improved infection prevention practices in&#xD;
      the participating NICUs and highlight lessons which other national and regional NICUs may&#xD;
      learn from.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background In 2012, it was estimated that approximately 680,000 neonatal deaths in developing&#xD;
      countries were due to bacterial infections, with an incidence risk of 7.6% and a case&#xD;
      fatality risk of 9.8. A major proportion of neonatal infections are expected to be&#xD;
      health-care associated, due to inadequate infrastructure and resources for infection control&#xD;
      and prevention. Hospital acquired infections(HAIs) are associated with multi-drug resistant&#xD;
      (MDR) bacteria, which increases the risk of therapeutic failure due to the limited choice of&#xD;
      available antibiotics. HAIs also lead to extended duration of admission, increased medical&#xD;
      costs, morbidity and mortality.&#xD;
&#xD;
      Transmission of MDR bacteria in the hospital environment is thought to be due to unhygienic&#xD;
      practices which occur during clinical invasive procedures, (e.g. artificial ventilation,&#xD;
      catheter and intravenous line insertion). Neonatal infections may also be due to invasion by&#xD;
      colonizing bacteria of the neonate, usually originating from maternal and environmental&#xD;
      flora.&#xD;
&#xD;
      According to the WHO, 50% of HAIs are preventable through implementation of infection control&#xD;
      practices. The WHO has instituted a multimodal hand hygiene strategy that has been found to&#xD;
      improve hand hygiene compliance and reduce the prevalence of HAIs. However, the effectiveness&#xD;
      of this strategy in a neonatal intensive care unit (NICU) with high risk of colonization with&#xD;
      environmental bacteria has not been studied. In fact, most studies that have examined the&#xD;
      potential sources and mode of transmission of organisms that cause neonatal sepsis have been&#xD;
      conducted in well-resourced countries.&#xD;
&#xD;
      The hypothesis of the study is that the hospital environment serves as a source of MDR Gram&#xD;
      negative bacteria responsible for neonatal colonization and sepsis among patients admitted at&#xD;
      the NICU of the KBTH; and that implementation of the multimodal hand hygiene strategy will&#xD;
      lead to a reduction in the incidence of neonatal sepsis and colonization by MDR Gram negative&#xD;
      bacteria.&#xD;
&#xD;
      Objective To determine the impact of multi-modal infection control interventions on the&#xD;
      incidence of neonatal sepsis and colonization by MDR Gram negative bacteria.&#xD;
&#xD;
      Method This study will evaluate the impact of WHO multimodal hand hygiene strategy on the&#xD;
      incidence of neonatal sepsis and neonatal colonization by MDR Gram negative bacteria as well&#xD;
      as pilot surveillance of neonatal sepsis at the participating sites.&#xD;
&#xD;
      Study setting: Data will be collected at the NICU of the KBTH and the 37 Military Hospital,&#xD;
      Accra, Ghana.&#xD;
&#xD;
      Study Design: The study will be a controlled before and after interventional trial with one&#xD;
      interventional site (KBTH) and a control site (37 Military hospital). Data will be collected&#xD;
      over 19 months with a baseline phase of 7 months; an interventional phase of 5 months; and a&#xD;
      post intervention phase of 7 months.&#xD;
&#xD;
      Intervention: The WHO multimodal hand hygiene strategy comprises five essential elements;&#xD;
      system change-availability of alcohol-based hand rub at the point of care and/ or access to&#xD;
      safe continuous water supply and soap and towels; training and education of healthcare&#xD;
      professionals; monitoring of hand hygiene practices and performance feedback; reminders in&#xD;
      the workplace; and the creation of a handhygiene safety culture with the participation of&#xD;
      both individual healthcare workers and senior hospital managers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Controlled before and after interventional trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of neonatal sepsis</measure>
    <time_frame>Post-intervention at 7 months</time_frame>
    <description>Incidence of neonatal sepsis including clinical cases treated as sepsis and cases of neonatal sepsis with confirmed bloodstream infections per 1000 admissions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of hand hygiene compliance per opportunity</measure>
    <time_frame>Post-intervention at 7 months</time_frame>
    <description>Hand hygiene events per opportunity for hand hygiene measured by direct observations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of MDR Gram negative bacteria colonization among neonates</measure>
    <time_frame>During intervention at 2 months and post-intervention at 7 months</time_frame>
    <description>Prevalence of MDR Gram negative bacteria among admitted neonates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of admission in days</measure>
    <time_frame>Post-intervention at 7 months</time_frame>
    <description>Days of admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>Post-intervention at 7 months</time_frame>
    <description>Mortality rates during admission</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5433</enrollment>
  <condition>Neonatal SEPSIS</condition>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Continuously monitoring of neonatal sepsis under standard of care at one site</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hand hygiene</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The WHO multimodal hand hygiene strategy is implemented at one site</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>The WHO multimodal hand hygiene strategy</intervention_name>
    <description>Comprises five essential elements; system change-availability of alcohol-based hand rub at the point of care and/ or access to safe continuous water supply and soap and towels; training and education of healthcare professionals; monitoring of hand hygiene practices and performance feedback; reminders in the workplace; and the creation of a hand hygiene safety culture with the participation of both individual healthcare workers and senior hospital managers.</description>
    <arm_group_label>Hand hygiene</arm_group_label>
    <other_name>Hand hygiene</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admission NICU&#xD;
&#xD;
          -  Birth weight ≥750 Grams&#xD;
&#xD;
          -  ≤48 hours of age at time of enrolment&#xD;
&#xD;
          -  Consent to participate obtained from legal guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neonates with severe congenital malformations&#xD;
&#xD;
          -  Neonates who have undergone surgical procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Minute</minimum_age>
    <maximum_age>48 Hours</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Appiah Korang Labi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Int. Health and Immunlogy Microbiology, University og Copenhagen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jørgen Kurtzhals, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Department of Int. Health and Immunlogy Microbiology, University og Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Korle Bu Teaching Hospital</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ghana</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>October 8, 2021</last_update_submitted>
  <last_update_submitted_qc>October 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Stephanie Bjerrum</investigator_full_name>
    <investigator_title>MD, PHD, postdoc</investigator_title>
  </responsible_party>
  <keyword>Neonatal sepsis</keyword>
  <keyword>Infection control</keyword>
  <keyword>Hand hygiene</keyword>
  <keyword>WHO multi modal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Toxemia</mesh_term>
    <mesh_term>Neonatal Sepsis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03755635
org study id: UM ID: 892333
nct id: NCT03755635
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Neonatal sepsis is a major contributor to global under five mortality. In
      developing countries a major proportion of neonatal sepsis is thought to emanate from the
      healthcare setting, due to challenges in infection prevention practices.

      Aim: To study the epidemiology of neonatal sepsis and evaluate the effect of multimodal
      infection control interventions on the incidence of neonatal sepsis; and colonization by
      multidrug resistant Gram negative bacteria (MDRGNB).

      Methods: A controlled before and after interventional trial comprising a 7 month pre-
      intervention phase, 5 month intervention phase and 7 month post-intervention phase. Neonates
      admitted at the Neonatal Intensive Care Unit (NICU) at Korle-Bu Teaching Hospital (KBTH) will
      be enrolled prospectively and followed up for diagnosis of sepsis and outcome of admission.
      This will be used to describe the epidemiology of neonatal sepsis. Swabs will be collected
      from a subpopulation of included neonates at intervention site (KBTH) and control site (37
      Military Hospital) NICUs to assess colonization of neonates with MDRGNB. Environmental swabs
      will be collected from surfaces at the NICU to assess MDRGNB contamination of the
      environment. The intervention comprises infection prevention strategies including
      implementation of the WHO multimodal hand hygiene strategy. The primary endpoint is incidence
      of neonatal sepsis.

      Expected Outcome: This study will contribute to improved infection prevention practices in
      the participating NICUs and highlight lessons which other national and regional NICUs may
      learn from.
Background In 2012, it was estimated that approximately 680,000 neonatal deaths in developing
      countries were due to bacterial infections, with an incidence risk of 7.6% and a case
      fatality risk of 9.8. A major proportion of neonatal infections are expected to be
      health-care associated, due to inadequate infrastructure and resources for infection control
      and prevention. Hospital acquired infections(HAIs) are associated with multi-drug resistant
      (MDR) bacteria, which increases the risk of therapeutic failure due to the limited choice of
      available antibiotics. HAIs also lead to extended duration of admission, increased medical
      costs, morbidity and mortality.

      Transmission of MDR bacteria in the hospital environment is thought to be due to unhygienic
      practices which occur during clinical invasive procedures, (e.g. artificial ventilation,
      catheter and intravenous line insertion). Neonatal infections may also be due to invasion by
      colonizing bacteria of the neonate, usually originating from maternal and environmental
      flora.

      According to the WHO, 50% of HAIs are preventable through implementation of infection control
      practices. The WHO has instituted a multimodal hand hygiene strategy that has been found to
      improve hand hygiene compliance and reduce the prevalence of HAIs. However, the effectiveness
      of this strategy in a neonatal intensive care unit (NICU) with high risk of colonization with
      environmental bacteria has not been studied. In fact, most studies that have examined the
      potential sources and mode of transmission of organisms that cause neonatal sepsis have been
      conducted in well-resourced countries.

      The hypothesis of the study is that the hospital environment serves as a source of MDR Gram
      negative bacteria responsible for neonatal colonization and sepsis among patients admitted at
      the NICU of the KBTH; and that implementation of the multimodal hand hygiene strategy will
      lead to a reduction in the incidence of neonatal sepsis and colonization by MDR Gram negative
      bacteria.

      Objective To determine the impact of multi-modal infection control interventions on the
      incidence of neonatal sepsis and colonization by MDR Gram negative bacteria.

      Method This study will evaluate the impact of WHO multimodal hand hygiene strategy on the
      incidence of neonatal sepsis and neonatal colonization by MDR Gram negative bacteria as well
      as pilot surveillance of neonatal sepsis at the participating sites.

      Study setting: Data will be collected at the NICU of the KBTH and the 37 Military Hospital,
      Accra, Ghana.

      Study Design: The study will be a controlled before and after interventional trial with one
      interventional site (KBTH) and a control site (37 Military hospital). Data will be collected
      over 19 months with a baseline phase of 7 months; an interventional phase of 5 months; and a
      post intervention phase of 7 months.

      Intervention: The WHO multimodal hand hygiene strategy comprises five essential elements;
      system change-availability of alcohol-based hand rub at the point of care and/ or access to
      safe continuous water supply and soap and towels; training and education of healthcare
      professionals; monitoring of hand hygiene practices and performance feedback; reminders in
      the workplace; and the creation of a handhygiene safety culture with the participation of
      both individual healthcare workers and senior hospital managers.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Controlled before and after interventional trial
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of neonatal sepsis
time frame: Post-intervention at 7 months
description: Incidence of neonatal sepsis including clinical cases treated as sepsis and cases of neonatal sepsis with confirmed bloodstream infections per 1000 admissions.
measure: Rate of hand hygiene compliance per opportunity
time frame: Post-intervention at 7 months
description: Hand hygiene events per opportunity for hand hygiene measured by direct observations
measure: Rate of MDR Gram negative bacteria colonization among neonates
time frame: During intervention at 2 months and post-intervention at 7 months
description: Prevalence of MDR Gram negative bacteria among admitted neonates
measure: Length of admission in days
time frame: Post-intervention at 7 months
description: Days of admission
measure: All-cause mortality
time frame: Post-intervention at 7 months
description: Mortality rates during admission
arm group label: Standard of care
arm group type: No Intervention
description: Continuously monitoring of neonatal sepsis under standard of care at one site
arm group label: Hand hygiene
arm group type: Experimental
description: The WHO multimodal hand hygiene strategy is implemented at one site
intervention type: Combination Product
intervention name: The WHO multimodal hand hygiene strategy
description: Comprises five essential elements; system change-availability of alcohol-based hand rub at the point of care and/ or access to safe continuous water supply and soap and towels; training and education of healthcare professionals; monitoring of hand hygiene practices and performance feedback; reminders in the workplace; and the creation of a hand hygiene safety culture with the participation of both individual healthcare workers and senior hospital managers.
arm group label: Hand hygiene
other name: Hand hygiene
criteria: 
gender: All
minimum age: 1 Minute
maximum age: 48 Hours
healthy volunteers: Accepts Healthy Volunteers
last name: Appiah Korang Labi, MD
role: Principal Investigator
affiliation: Department of Int. Health and Immunlogy Microbiology, University og Copenhagen
last name: Jørgen Kurtzhals, Professor
role: Study Director
affiliation: Department of Int. Health and Immunlogy Microbiology, University og Copenhagen
facility: 
country: Ghana
responsible party type: Sponsor-Investigator
investigator affiliation: University of Copenhagen
investigator full name: Stephanie Bjerrum
investigator title: MD, PHD, postdoc
mesh term: Sepsis
mesh term: Toxemia
mesh term: Neonatal Sepsis
sharing ipd: Undecided