<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/NCT03243266</url>
  </required_header>
  <id_info>
    <org_study_id>B90590</org_study_id>
    <nct_id>NCT03243266</nct_id>
  </id_info>
  <brief_title>DxH520 Pediatric Reference Interval Verification</brief_title>
  <official_title>DxH520 Pediatric Reference Interval Verification</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beckman Coulter, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beckman Coulter, Inc.</source>
  <brief_summary>
    <textblock>
      Results from this study will be used to verify that the published pediatric reference&#xD;
      intervals are met on the DxH 520 Hematology Analyzer for the pediatric age ranges.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pediatric specimens from each age range will be tested from apparently healthy children. Ten&#xD;
      male and Ten female are required for each age range. The values will be assessed against&#xD;
      published reference ranges to verify that the values obtained fall within the expected&#xD;
      reference interval for the age ranges listed below:&#xD;
&#xD;
        1. Neonate: 0 to 30 days&#xD;
&#xD;
        2. Infant: &gt; 30 days to 2 years&#xD;
&#xD;
        3. Child: 3 years to 12 years&#xD;
&#xD;
        4. Adolescent: 13 years to 21 years&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2017</start_date>
  <completion_date type="Actual">May 2, 2018</completion_date>
  <primary_completion_date type="Actual">May 2, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pediatric Reference Interval Verification of Hematology CBC/Diff parameters</measure>
    <time_frame>1 day</time_frame>
    <description>Verify Reference Intervals of Hematology CBC/Diff parameters in pediatric age groups. The blood cell count test parameters to be verified are:&#xD;
White Blood Cells (x10^3/µL), Red Blood Cells (x10^6/µL), Hemoglobin (g/dL), Hematocrit %, Mean Corpuscular Hemoglobin (pg), Mean Corpuscular Hemoglobin Concentration (g/dL), Mean Corpuscular Volume (fL), Red Cell Distribution Width-CV (%) Red cell Distribution Width-SD (fL), Platelets (x10^3/µL), Mean Platelet Volume (fL), Neutrophil %, Neutrophil Count (x10^3/µL), Lymphocyte %, Lymphocyte Count (x10^3/µL), Monocyte %, Monocyte Count (x10^3/µL), Eosinophil %, Eosinophil Count (x10^3/µL), Basophil %, Basophil Count (x10^3/µL). Study results will be analyzed following CLSI guideline EP28-A3c.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">290</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>CBC/Diff Reference Interval</arm_group_label>
    <description>Hematology routine diagnostic test</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CBC/Diff Reference Interval</intervention_name>
    <description>Results will not be used to manage patients</description>
    <arm_group_label>CBC/Diff Reference Interval</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric specimens from apparently healthy children&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All subject genders, race and ethnicity will be included in the study. Pediatric&#xD;
             samples will be targeted for this study within the specified age ranges.&#xD;
&#xD;
          -  Specimens should be from apparently healthy individuals.&#xD;
&#xD;
          -  Samples from inpatient and ED visits maybe included if they are confirmed to be the&#xD;
             final CBC before discharge and the patient had a non-hematological diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Samples originating from a hematology/oncology clinic (both inpatient and outpatient)&#xD;
&#xD;
          -  Samples originating from a patient with a hematological disorder or diagnosis&#xD;
&#xD;
          -  Samples from the Neonatal Intensive Care Unit that are not the last specimens&#xD;
             collected prior to discharge&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Male, Female</gender_description>
    <minimum_age>1 Minute</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Khosrow Adeli, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Meer-Taher Shabani-Rad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alberta Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alberta Children's Hospital</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>July 11, 2018</last_update_submitted>
  <last_update_submitted_qc>July 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03243266
org study id: B90590
nct id: NCT03243266
lead sponsor: 
Results from this study will be used to verify that the published pediatric reference
      intervals are met on the DxH 520 Hematology Analyzer for the pediatric age ranges.
Pediatric specimens from each age range will be tested from apparently healthy children. Ten
      male and Ten female are required for each age range. The values will be assessed against
      published reference ranges to verify that the values obtained fall within the expected
      reference interval for the age ranges listed below:

        1. Neonate: 0 to 30 days

        2. Infant: > 30 days to 2 years

        3. Child: 3 years to 12 years

        4. Adolescent: 13 years to 21 years
observational model: Cohort
time perspective: Cross-Sectional
measure: Pediatric Reference Interval Verification of Hematology CBC/Diff parameters
time frame: 1 day
description: Verify Reference Intervals of Hematology CBC/Diff parameters in pediatric age groups. The blood cell count test parameters to be verified are:
White Blood Cells (x10^3/µL), Red Blood Cells (x10^6/µL), Hemoglobin (g/dL), Hematocrit %, Mean Corpuscular Hemoglobin (pg), Mean Corpuscular Hemoglobin Concentration (g/dL), Mean Corpuscular Volume (fL), Red Cell Distribution Width-CV (%) Red cell Distribution Width-SD (fL), Platelets (x10^3/µL), Mean Platelet Volume (fL), Neutrophil %, Neutrophil Count (x10^3/µL), Lymphocyte %, Lymphocyte Count (x10^3/µL), Monocyte %, Monocyte Count (x10^3/µL), Eosinophil %, Eosinophil Count (x10^3/µL), Basophil %, Basophil Count (x10^3/µL). Study results will be analyzed following CLSI guideline EP28-A3c.
arm group label: CBC/Diff Reference Interval
description: Hematology routine diagnostic test
intervention type: Diagnostic Test
intervention name: CBC/Diff Reference Interval
description: Results will not be used to manage patients
arm group label: CBC/Diff Reference Interval
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: Male, Female
minimum age: 1 Minute
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Khosrow Adeli, Ph.D
role: Principal Investigator
affiliation: The Hospital for Sick Children
last name: Meer-Taher Shabani-Rad, MD
role: Principal Investigator
affiliation: Alberta Children's Hospital
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor