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/NCT06039618</url>
    </required_header>
    <id_info>
      <org_study_id>02-09/2-77/20</org_study_id>
      <nct_id>NCT06039618</nct_id>
    </id_info>
    <brief_title>Capabilities of Perinatal Healthcare Institutions in the Federation of Bosnia and Herzegovina</brief_title>
    <official_title>Capabilities of Perinatal Healthcare Institutions in Primary and Tertiary Care of Low Birth Weight Infants in the Federation of Bosnia and Herzegovina: A Cross-sectional Multicentric Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Evangelisches Krankenhaus Bethesda zu Duisburg</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Evangelisches Krankenhaus Bethesda zu Duisburg</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to assess the level of the perinatal healthcare institution (PHI)&#xD;
        where the newborns were delivered. We included newborns of both genders that were born in the&#xD;
        maternity wards in 10 cantons of the Federation of Bosnia and Herzegovina (FBiH). From the&#xD;
        PHI of the first and second level, 159 newborns were referred to the third level. Out of a&#xD;
        total of 159 LBWI referred from other PHI, only 19.5% LBWI were transported in less than 4&#xD;
        hours. In second level PHI, most LBWI died in the first 12 hours after birth.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2013</start_date>
    <completion_date type="Actual">December 31, 2017</completion_date>
    <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Referral to a centre of higher organizational level.</measure>
      <time_frame>Before birth and up to 4 hours or more after delivery.</time_frame>
      <description>Referring the neonate with low birth weight to a more specialized centre.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">22897</enrollment>
    <condition>Prenatal Care</condition>
    <arm_group>
      <arm_group_label>Referred to a Centre of Higher Level</arm_group_label>
      <description>Those are the newborns that were referred at the time of delivery or within one week after birth to centers of higher organizational level.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treated at the Centre of Admission</arm_group_label>
      <description>Those are the newborns that were not referred to other centers and were treated in the health facility were the birth took place, and hospitalized in the same center until discharge.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Referral to Centre of Higher Organizational Level</intervention_name>
      <description>Referral to Centre of Higher Organizational Level. This means referral from a primary neonatal care center to a secondary one, or from the secondary to the tertiary center.</description>
      <arm_group_label>Referred to a Centre of Higher Level</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Newborns that were born in the maternity wards of the Federation of Bosnia and Herzegovina&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Newborns of both genders that were born in the maternity wards in 10 cantons of the&#xD;
               FBiH&#xD;
  &#xD;
            -  A gestational age between 22 and 42 weeks, and a birth weight less than 2500g.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Infants younger than 22 weeks or older than 42 weeks.&#xD;
  &#xD;
            -  Infants whose mothers refused to give consent for participation in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Weeks</minimum_age>
      <maximum_age>42 Weeks</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anis Cerovac, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>General Hospital Tešanj</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>General Hospital Tešanj</name>
        <address>
          <city>Tešanj</city>
          <country>Bosnia and Herzegovina</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Bosnia and Herzegovina</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Evangelisches Krankenhaus Bethesda zu Duisburg</investigator_affiliation>
      <investigator_full_name>Antoine Naem</investigator_full_name>
      <investigator_title>Research Assistant</investigator_title>
    </responsible_party>
    <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/NCT06039618
  org study id: 02-09/2-77/20
  nct id: NCT06039618
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to assess the level of the perinatal healthcare institution (PHI)
        where the newborns were delivered. We included newborns of both genders that were born in the
        maternity wards in 10 cantons of the Federation of Bosnia and Herzegovina (FBiH). From the
        PHI of the first and second level, 159 newborns were referred to the third level. Out of a
        total of 159 LBWI referred from other PHI, only 19.5% LBWI were transported in less than 4
        hours. In second level PHI, most LBWI died in the first 12 hours after birth.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Referral to a centre of higher organizational level.
  time frame: Before birth and up to 4 hours or more after delivery.
  description: Referring the neonate with low birth weight to a more specialized centre.
  arm group label: Referred to a Centre of Higher Level
  description: Those are the newborns that were referred at the time of delivery or within one week after birth to centers of higher organizational level.
  arm group label: Treated at the Centre of Admission
  description: Those are the newborns that were not referred to other centers and were treated in the health facility were the birth took place, and hospitalized in the same center until discharge.
  intervention type: Other
  intervention name: Referral to Centre of Higher Organizational Level
  description: Referral to Centre of Higher Organizational Level. This means referral from a primary neonatal care center to a secondary one, or from the secondary to the tertiary center.
  arm group label: Referred to a Centre of Higher Level
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 22 Weeks
  maximum age: 42 Weeks
  healthy volunteers: Accepts Healthy Volunteers
  last name: Anis Cerovac, M.D.
  role: Principal Investigator
  affiliation: General Hospital Tešanj
  facility: 
  country: Bosnia and Herzegovina
  responsible party type: Principal Investigator
  investigator affiliation: Evangelisches Krankenhaus Bethesda zu Duisburg
  investigator full name: Antoine Naem
  investigator title: Research Assistant
  sharing ipd: No