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/NCT05985174</url>
    </required_header>
    <id_info>
      <org_study_id>Soh-Med-23-07-13MS</org_study_id>
      <nct_id>NCT05985174</nct_id>
    </id_info>
    <brief_title>Role of Neutrophil CD64 and Monocyte HLA-DR Markers in the Dignosis of Neonatal Sepsis</brief_title>
    <official_title>Role of Neutrophil CD64 and Monocyte HLA-DR Markers in the Dignosis of Neonatal Sepsis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag University</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>
        Neonatal septicemia remains one of the main causes of neonatal morbidity and mortality .&#xD;
        Sepsis which is caused by a dysregulated host response to an infectious trigger leading to a&#xD;
        life threatening organ dysfunction was declared by the World Health Organization (WHO) on May&#xD;
        2017 as a global health priority that requires resolution for its prevention , dignosis , and&#xD;
        management (Monneret et al., 2019). Despite the advances in perinatal and neonatal sepsis&#xD;
        remains high and the outcome is still sever (Chirio et al.,2011) .&#xD;
  &#xD;
        HLA-DR is on the surface of monocyte \ macrophages , dendritic cells, and B cells and plays a&#xD;
        crucial role in adaptive immune response , More than 30 years ago , researches proved an&#xD;
        association between the low level of HLA-DR and the development of sepsis (Cheadle at al&#xD;
        .,1991) . A decreased expression of mHLA-DR molecules has been associated with&#xD;
        immunoparalysis , which is an inflammatory immune responce that occurs in sepsis .(Pradhan et&#xD;
        al.,2016).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>CD64 from a peripheral blood sample measued by FlowCytometry device .</measure>
      <time_frame>12 months</time_frame>
      <description>A cluster of differentiation 64 is a type of intergral membrane glycoprotein , when activated , it increases the neutrophil, potential for phagocytosis and bacterial killing .</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Neonatal Sepsis</condition>
    <arm_group>
      <arm_group_label>cases</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Neonates of both sexes included in this study with any suspected case of neonatal sepsis with maternal risk factors , e.g., prolonged labor , premature rupture of membrane (PROM) , maternal intrapartum fever and chorioamnionitis , and neonates with sepsis-related clinical signs :temparature instability , apnea , need for supplemental oxygen , bradycardia , tachycardia , hypotension , hypo&#xD;
  perfusion , feeding intolerance , and abdominal distension .</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>CD64 , HLA-DR</intervention_name>
      <description>CD64 is atype of integral membrane glycoprotein , when activated , it increases the neutrophils' potential for phagocytosis and bacterial killing .&#xD;
  HLA-DR is on the surface of monocyte\macrophages , dendritic cells and plays a crucial role in adaptive immune response</description>
      <arm_group_label>cases</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Neonates of both sexes included in this study with any suspected case of neonatal&#xD;
               sepsis with maternal risk factors for sepsis , e.g., prolonged labor , premature&#xD;
               rupture of membrane (PROM) , maternal intrapartum fever and chorioamnionitis , and&#xD;
               neonates with sepsis-related clinical signs: temperature instability, apnea , need for&#xD;
               supplemental oxygen ,bradycardia , tachycardia , hypotension , hypoperfusion , feeding&#xD;
               intolerance and abdominal distension ,&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  are the adminstration of antibiotic therapy prior to admission , birth asphyxia ,&#xD;
               laboratory finding suggestive of inborn error of metabolism , and congenital anomalies&#xD;
               including congenital heart diseases .&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Day</minimum_age>
      <maximum_age>28 Days</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Aya G Mostafa, Resident</last_name>
      <phone>01009389427</phone>
      <email>ayagamal@med.sohag.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Laila M Yousef, Professor</last_name>
      <phone>01002976973</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sohag University hospitals</name>
        <address>
          <city>Sohag</city>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Magdy M Amin, Professor</last_name>
        <phone>0934602963</phone>
        <email>portal@med.sohag.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Chirico G, Loda C. Laboratory aid to the diagnosis and therapy of infection in the neonate. Pediatr Rep. 2011 Feb 24;3(1):e1. doi: 10.4081/pr.2011.e1.</citation>
      <PMID>21647274</PMID>
    </reference>
    <reference>
      <citation>Ng PC, Lam HS. Diagnostic markers for neonatal sepsis. Curr Opin Pediatr. 2006 Apr;18(2):125-31. doi: 10.1097/01.mop.0000193293.87022.4c.</citation>
      <PMID>16601490</PMID>
    </reference>
    <reference>
      <citation>Vazquez Rodriguez S, Arriaga Pizano LA, Laresgoiti Servitje E, Mancilla Ramirez J, Peralta Mendez OL, Villalobos Alcazar G, Granados Cepeda ML, Hernandez Pelaez MG, Cordero Gonzalez G, Arizmendi Villanueva R, Cruz Ramirez JL, Isibasi A, Lopez Macias C, Flores Romo L, Jimenez Zamudio LA, Cerbulo-Vazquez A. Multiparameter flow cytometry analysis of leukocyte markers for diagnosis in preterm neonatal sepsis. J Matern Fetal Neonatal Med. 2021 Jul;34(14):2323-2333. doi: 10.1080/14767058.2019.1666100. Epub 2019 Sep 19.</citation>
      <PMID>31537145</PMID>
    </reference>
    <reference>
      <citation>Aydin M, Barut S, Akbulut HH, Ucar S, Orman A. Application of Flow Cytometry in the Early Diagnosis of Neonatal Sepsis. Ann Clin Lab Sci. 2017 Mar;47(2):184-190.</citation>
      <PMID>28442521</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Aya Gamal Mostafa</investigator_full_name>
      <investigator_title>Resident of clinical and chemical pathology department, Sohag university hospital</investigator_title>
    </responsible_party>
    <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>
  
  
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/NCT05985174
  org study id: Soh-Med-23-07-13MS
  nct id: NCT05985174
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Neonatal septicemia remains one of the main causes of neonatal morbidity and mortality .
        Sepsis which is caused by a dysregulated host response to an infectious trigger leading to a
        life threatening organ dysfunction was declared by the World Health Organization (WHO) on May
        2017 as a global health priority that requires resolution for its prevention , dignosis , and
        management (Monneret et al., 2019). Despite the advances in perinatal and neonatal sepsis
        remains high and the outcome is still sever (Chirio et al.,2011) .
  
        HLA-DR is on the surface of monocyte \ macrophages , dendritic cells, and B cells and plays a
        crucial role in adaptive immune response , More than 30 years ago , researches proved an
        association between the low level of HLA-DR and the development of sepsis (Cheadle at al
        .,1991) . A decreased expression of mHLA-DR molecules has been associated with
        immunoparalysis , which is an inflammatory immune responce that occurs in sepsis .(Pradhan et
        al.,2016).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: CD64 from a peripheral blood sample measued by FlowCytometry device .
  time frame: 12 months
  description: A cluster of differentiation 64 is a type of intergral membrane glycoprotein , when activated , it increases the neutrophil, potential for phagocytosis and bacterial killing .
  arm group label: cases
  arm group type: Experimental
  description: Neonates of both sexes included in this study with any suspected case of neonatal sepsis with maternal risk factors , e.g., prolonged labor , premature rupture of membrane (PROM) , maternal intrapartum fever and chorioamnionitis , and neonates with sepsis-related clinical signs :temparature instability , apnea , need for supplemental oxygen , bradycardia , tachycardia , hypotension , hypo
  perfusion , feeding intolerance , and abdominal distension .
  intervention type: Diagnostic Test
  intervention name: CD64 , HLA-DR
  description: CD64 is atype of integral membrane glycoprotein , when activated , it increases the neutrophils' potential for phagocytosis and bacterial killing .
  HLA-DR is on the surface of monocyte\macrophages , dendritic cells and plays a crucial role in adaptive immune response
  arm group label: cases
  criteria: 
  gender: All
  minimum age: 1 Day
  maximum age: 28 Days
  healthy volunteers: No
  last name: Aya G Mostafa, Resident
  phone: 01009389427
  email: ayagamal@med.sohag.edu.eg
  last name: Laila M Yousef, Professor
  phone: 01002976973
  facility: 
  contact: 
  country: Egypt
  citation: Chirico G, Loda C. Laboratory aid to the diagnosis and therapy of infection in the neonate. Pediatr Rep. 2011 Feb 24;3(1):e1. doi: 10.4081/pr.2011.e1.
  PMID: 21647274
  citation: Ng PC, Lam HS. Diagnostic markers for neonatal sepsis. Curr Opin Pediatr. 2006 Apr;18(2):125-31. doi: 10.1097/01.mop.0000193293.87022.4c.
  PMID: 16601490
  citation: Vazquez Rodriguez S, Arriaga Pizano LA, Laresgoiti Servitje E, Mancilla Ramirez J, Peralta Mendez OL, Villalobos Alcazar G, Granados Cepeda ML, Hernandez Pelaez MG, Cordero Gonzalez G, Arizmendi Villanueva R, Cruz Ramirez JL, Isibasi A, Lopez Macias C, Flores Romo L, Jimenez Zamudio LA, Cerbulo-Vazquez A. Multiparameter flow cytometry analysis of leukocyte markers for diagnosis in preterm neonatal sepsis. J Matern Fetal Neonatal Med. 2021 Jul;34(14):2323-2333. doi: 10.1080/14767058.2019.1666100. Epub 2019 Sep 19.
  PMID: 31537145
  citation: Aydin M, Barut S, Akbulut HH, Ucar S, Orman A. Application of Flow Cytometry in the Early Diagnosis of Neonatal Sepsis. Ann Clin Lab Sci. 2017 Mar;47(2):184-190.
  PMID: 28442521
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Aya Gamal Mostafa
  investigator title: Resident of clinical and chemical pathology department, Sohag university hospital
  mesh term: Sepsis
  mesh term: Toxemia
  mesh term: Neonatal Sepsis
  sharing ipd: Undecided