xml: <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/NCT05993442</url>
    </required_header>
    <id_info>
      <org_study_id>NeoDeco</org_study_id>
      <nct_id>NCT05993442</nct_id>
    </id_info>
    <brief_title>Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation in NICU</brief_title>
    <acronym>NeoDeco</acronym>
    <official_title>Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU: a Pragmatic, Multicentre, Parallel Cluster Randomised Hybrid Implementation Effectiveness Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>PENTA Foundation</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>PENTA Foundation</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>
        NeoDeco is a pragmatic, multicenter, parallel group, cluster randomised hybrid&#xD;
        effectiveness-implementation study with baseline assessment, wash-in period and staggered&#xD;
        randomisation. All sites will be offered the implementation support for optimised Kangaroo&#xD;
        Care (KC) as part of the study; however, intervention sites will be randomised to immediate&#xD;
        receipt of implementation support whereas standard care sites will be offered this after the&#xD;
        study period.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The NeoDECO trial is a cluster randomised trial of 24 neonatal units in 5 European countries&#xD;
        (Switzerland, Italy, Greece, Spain and United Kingdom). Each neonatal unit/site is a cluster&#xD;
        and the intervention is applied at the unit-level.&#xD;
  &#xD;
        Sites will be grouped into so-called staggers to enable phased randomisation to receive&#xD;
        implementation support for optimised KC or to continued standard care. Therefore, sites&#xD;
        within each group will be randomised to the intervention or control (standard care) arm.&#xD;
  &#xD;
        At the end of the baseline period, which is identical for all sites, randomisation will&#xD;
        occur. Intervention sites will then undergo a 2-month wash-in phase during which time they&#xD;
        will receive training and workshops on implementation strategies for optimised KC.&#xD;
  &#xD;
        Following the wash-in phase, the intervention period will last 12 months for intervention&#xD;
        sites during which time optimised KC (defined as early, repeated and sustained StSC) will be&#xD;
        continuously implemented.&#xD;
  &#xD;
        All sites (both intervention and control arm) will carry out a baseline data collection phase&#xD;
        of clinical surveillance and colonisation assessments while employing current standard care&#xD;
        for Kangaroo Care, including for StSC practices. Specifically, all sites will also conduct&#xD;
        weekly colonisation assessments (point prevalence surveys) of skin swabs and stool samples&#xD;
        and clinical data of all babies on the unit on the day of the assessment.&#xD;
  &#xD;
        Exploratory implementation work will also occur during the baseline phase to understand&#xD;
        current practices, implementation determinants and resources needed for designing&#xD;
        implementation strategies. In addition, one representative site per country from the&#xD;
        intervention arm will be selected for further in-depth engagement and data collection with&#xD;
        the implementation team collect further information on fidelity to the intervention and&#xD;
        implementation strategies including acceptability, appropriateness, feasibility and&#xD;
        sustainability.&#xD;
  &#xD;
        At the end of the intervention period, all controls sites will be supported and trained to&#xD;
        implement optimised KC using selected implementation strategies.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">February 2024</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Neonatal severe infection/sepsis</measure>
      <time_frame>12 months</time_frame>
      <description>The cumulative incidence of neonatal severe infection/sepsis in high-risk infants during their NICU stay will be analysed using mixed-effects logistic regression analysis with a random intercept for hospital. The determinant of interest will be the randomly allocated intervention. Co-variates in the analysis include the variables used for restricted randomisation and important individual-level infant characteristics present at admission: birth weight group, gestational age group and mode of delivery (vaginal birth or Caesarean section).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Resistant bacterial colonisation over time</measure>
      <time_frame>12 months</time_frame>
      <description>The prevalence of resistant bacterial colonisation over time in high-risk infants admitted to the NICU will be analysed using mixed effects time-series analysis with a random intercept and random time-slope at the hospital level. Individual data will be analysed with a binary outcome (detection or no detection). Data of the pre-trial and full trial period will be visualised, but only PPS collected after the wash-in period (or after the same period in control hospitals) will be analysed in the primary analysis. The two determinants of interest are (1) allocated intervention group and (2) time in months since end of the wash-in period (being zero for control hospitals), including the same co-variates as for neonatal severe infection/sepsis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of neonatal sever infections</measure>
      <time_frame>12 months</time_frame>
      <description>The study will assess the effect of the intervention among all infants on the cumulative incidence of neonatal severe infection/sepsis, laboratory-confirmed bloodstream infections, clinical sepsis and necrotising enterocolitis (NEC)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of neonatal morbidity</measure>
      <time_frame>12 months</time_frame>
      <description>The study will evaluate the composite outcome of major neonatal morbidity, defined as laboratory-confirmed sepsis, NEC, high-grade ROP, high-grade IVH, BPD or death during NICU stay, and the effect of the intervention in high-risk infants using a negative binomial model, adjusted for the cumulative incidence of the same endpoints in the year before start of the trial.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Incidence of SSIs</measure>
      <time_frame>12 months</time_frame>
      <description>The study will explore the effect of the intervention among high-risk infants and all infants on cumulative incidences of SSIs, including superficial, deep or organ-space SSI, pneumonia (including VAP) and DAIs.</description>
    </other_outcome>
    <other_outcome>
      <measure>Prevalence of breastfeeding</measure>
      <time_frame>12 months</time_frame>
      <description>The study will compare prevalence of breastfeeding and mother's milk intake over time as well as human milk intake among high-risk infants and all infants in both groups.</description>
    </other_outcome>
    <other_outcome>
      <measure>Incremental cost-effectiveness ratio (ICER)</measure>
      <time_frame>12 months</time_frame>
      <description>The incremental cost-effectiveness ratio (ICER) of the intervention compared to the standard care using indicators from the trial outcomes will be calculated to estimate a range of ICERs, including the incremental cost per case of infection averted, cost per life-year gained, and cost per disability-adjusted life-years (DALYs) averted.</description>
    </other_outcome>
    <other_outcome>
      <measure>Budget impact of the intervention arm</measure>
      <time_frame>12 months</time_frame>
      <description>A sensitivity analysis to assess the robustness of cost-effectiveness analyses results to changes in assumptions or inputs will be performed. This may entail testing various scenarios or different assumptions about the costs or benefits of optimised KC. Further, the budget impact of scaling-up the intervention's coverage for the health systems of the countries included in the study will be estimated, if proved effective and cost-effective.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">11440</enrollment>
    <condition>Infection, Bacterial</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The sites randomised in this group will adapt the study intervention consisting of:&#xD;
  Component 1: Skin-to-skin contact for optimised KC, describes the targeted level of skin-to-skin contact (StSC) considered to represent optimised KC in a high-technology neonatal unit environment in which KC is already offered as part of routine care.&#xD;
  Component 2: Implementation Support aims to engage clinical staff in the neonatal unit who are involved in implementing StSC as part of optimised KC.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The sites randomised in this group will follow the standard care, including KC and StSC sessions, treatment of severe infections/sepsis and infection prevention and control measures based on current routine local practice.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Optimising kangaroo care</intervention_name>
      <description>The intervention of optimised KC implementation consists of two components. Component 1 defines the targeted StSC for optimised KC, while component 2 is the implementation support to put in place a tailored implementation strategy.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          In NeoDeco there are no participant inclusion or exclusion criteria because this is a&#xD;
          cluster randomised trial, so the intervention will be applied to all babies admitted to the&#xD;
          neonatal intensive care unit as a cluster.&#xD;
  &#xD;
          However, the neonatal intensive care units will have to meet the following criteria to be&#xD;
          involved in the study:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  • European NICUs that provide routine care of extremely premature infants (&lt; 28 weeks'&#xD;
               gestational age).&#xD;
  &#xD;
                 -  Minimum number of 12 beds offering highest level of neonatal intensive care.&#xD;
  &#xD;
                 -  Availability of or access to -70 to -80°C freezer for storage of research&#xD;
                    samples.&#xD;
  &#xD;
                 -  Willing to implement optimised KC if allocated to the intervention group.&#xD;
  &#xD;
                 -  Prepared to implement NeoIPC surveillance and to provide anonymous surveillance&#xD;
                    data.&#xD;
  &#xD;
                 -  Adequate resources and expertise and approvals from relevant Research Ethics&#xD;
                    Committees, as appropriate.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Implementation of a daily average StSC duration of 4 hours or more.&#xD;
  &#xD;
            -  Major expected changes in resistant bacterial colonisation pressure during the trial&#xD;
               period, for example due to planned move to a new ward.&#xD;
  &#xD;
            -  Participation in other research projects which might directly influence the trial&#xD;
               intervention or outcome.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>28 Weeks</minimum_age>
      <maximum_age>32 Weeks</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Julia Bielicki, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>St George's, University of London</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Federica D'Ambrosio</last_name>
      <phone>+39 378 302 9089</phone>
      <email>federica.dambrosio@pentafoundation.org</email>
    </overall_contact>
    <link>
      <url>https://neoipc.org/</url>
      <description>NeoDeco study is part of the NeoIPC project funded by the European Commission.</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Nosocomial Infection</keyword>
    <keyword>Prevention</keyword>
    <keyword>Bacterial</keyword>
    <keyword>Cluster</keyword>
    <keyword>Implementation science</keyword>
    <keyword>Surveillance</keyword>
    <keyword>Neonatal unit</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>Bacterial Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05993442
  org study id: NeoDeco
  nct id: NCT05993442
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  NeoDeco is a pragmatic, multicenter, parallel group, cluster randomised hybrid
        effectiveness-implementation study with baseline assessment, wash-in period and staggered
        randomisation. All sites will be offered the implementation support for optimised Kangaroo
        Care (KC) as part of the study; however, intervention sites will be randomised to immediate
        receipt of implementation support whereas standard care sites will be offered this after the
        study period.
  The NeoDECO trial is a cluster randomised trial of 24 neonatal units in 5 European countries
        (Switzerland, Italy, Greece, Spain and United Kingdom). Each neonatal unit/site is a cluster
        and the intervention is applied at the unit-level.
  
        Sites will be grouped into so-called staggers to enable phased randomisation to receive
        implementation support for optimised KC or to continued standard care. Therefore, sites
        within each group will be randomised to the intervention or control (standard care) arm.
  
        At the end of the baseline period, which is identical for all sites, randomisation will
        occur. Intervention sites will then undergo a 2-month wash-in phase during which time they
        will receive training and workshops on implementation strategies for optimised KC.
  
        Following the wash-in phase, the intervention period will last 12 months for intervention
        sites during which time optimised KC (defined as early, repeated and sustained StSC) will be
        continuously implemented.
  
        All sites (both intervention and control arm) will carry out a baseline data collection phase
        of clinical surveillance and colonisation assessments while employing current standard care
        for Kangaroo Care, including for StSC practices. Specifically, all sites will also conduct
        weekly colonisation assessments (point prevalence surveys) of skin swabs and stool samples
        and clinical data of all babies on the unit on the day of the assessment.
  
        Exploratory implementation work will also occur during the baseline phase to understand
        current practices, implementation determinants and resources needed for designing
        implementation strategies. In addition, one representative site per country from the
        intervention arm will be selected for further in-depth engagement and data collection with
        the implementation team collect further information on fidelity to the intervention and
        implementation strategies including acceptability, appropriateness, feasibility and
        sustainability.
  
        At the end of the intervention period, all controls sites will be supported and trained to
        implement optimised KC using selected implementation strategies.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Neonatal severe infection/sepsis
  time frame: 12 months
  description: The cumulative incidence of neonatal severe infection/sepsis in high-risk infants during their NICU stay will be analysed using mixed-effects logistic regression analysis with a random intercept for hospital. The determinant of interest will be the randomly allocated intervention. Co-variates in the analysis include the variables used for restricted randomisation and important individual-level infant characteristics present at admission: birth weight group, gestational age group and mode of delivery (vaginal birth or Caesarean section).
  measure: Resistant bacterial colonisation over time
  time frame: 12 months
  description: The prevalence of resistant bacterial colonisation over time in high-risk infants admitted to the NICU will be analysed using mixed effects time-series analysis with a random intercept and random time-slope at the hospital level. Individual data will be analysed with a binary outcome (detection or no detection). Data of the pre-trial and full trial period will be visualised, but only PPS collected after the wash-in period (or after the same period in control hospitals) will be analysed in the primary analysis. The two determinants of interest are (1) allocated intervention group and (2) time in months since end of the wash-in period (being zero for control hospitals), including the same co-variates as for neonatal severe infection/sepsis.
  measure: Incidence of neonatal sever infections
  time frame: 12 months
  description: The study will assess the effect of the intervention among all infants on the cumulative incidence of neonatal severe infection/sepsis, laboratory-confirmed bloodstream infections, clinical sepsis and necrotising enterocolitis (NEC)
  measure: Incidence of neonatal morbidity
  time frame: 12 months
  description: The study will evaluate the composite outcome of major neonatal morbidity, defined as laboratory-confirmed sepsis, NEC, high-grade ROP, high-grade IVH, BPD or death during NICU stay, and the effect of the intervention in high-risk infants using a negative binomial model, adjusted for the cumulative incidence of the same endpoints in the year before start of the trial.
  measure: Incidence of SSIs
  time frame: 12 months
  description: The study will explore the effect of the intervention among high-risk infants and all infants on cumulative incidences of SSIs, including superficial, deep or organ-space SSI, pneumonia (including VAP) and DAIs.
  measure: Prevalence of breastfeeding
  time frame: 12 months
  description: The study will compare prevalence of breastfeeding and mother's milk intake over time as well as human milk intake among high-risk infants and all infants in both groups.
  measure: Incremental cost-effectiveness ratio (ICER)
  time frame: 12 months
  description: The incremental cost-effectiveness ratio (ICER) of the intervention compared to the standard care using indicators from the trial outcomes will be calculated to estimate a range of ICERs, including the incremental cost per case of infection averted, cost per life-year gained, and cost per disability-adjusted life-years (DALYs) averted.
  measure: Budget impact of the intervention arm
  time frame: 12 months
  description: A sensitivity analysis to assess the robustness of cost-effectiveness analyses results to changes in assumptions or inputs will be performed. This may entail testing various scenarios or different assumptions about the costs or benefits of optimised KC. Further, the budget impact of scaling-up the intervention's coverage for the health systems of the countries included in the study will be estimated, if proved effective and cost-effective.
  arm group label: Intervention group
  arm group type: Experimental
  description: The sites randomised in this group will adapt the study intervention consisting of:
  Component 1: Skin-to-skin contact for optimised KC, describes the targeted level of skin-to-skin contact (StSC) considered to represent optimised KC in a high-technology neonatal unit environment in which KC is already offered as part of routine care.
  Component 2: Implementation Support aims to engage clinical staff in the neonatal unit who are involved in implementing StSC as part of optimised KC.
  arm group label: Control group
  arm group type: No Intervention
  description: The sites randomised in this group will follow the standard care, including KC and StSC sessions, treatment of severe infections/sepsis and infection prevention and control measures based on current routine local practice.
  intervention type: Behavioral
  intervention name: Optimising kangaroo care
  description: The intervention of optimised KC implementation consists of two components. Component 1 defines the targeted StSC for optimised KC, while component 2 is the implementation support to put in place a tailored implementation strategy.
  arm group label: Intervention group
  criteria: 
  gender: All
  minimum age: 28 Weeks
  maximum age: 32 Weeks
  healthy volunteers: No
  last name: Julia Bielicki, PhD
  role: Study Chair
  affiliation: St George's, University of London
  last name: Federica D'Ambrosio
  phone: +39 378 302 9089
  email: federica.dambrosio@pentafoundation.org
  url: https://neoipc.org/
  description: NeoDeco study is part of the NeoIPC project funded by the European Commission.
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Bacterial Infections
  sharing ipd: No