<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/NCT03767361</url>
  </required_header>
  <id_info>
    <org_study_id>MS2015</org_study_id>
    <nct_id>NCT03767361</nct_id>
  </id_info>
  <brief_title>Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates</brief_title>
  <official_title>Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rania Ali El-Farrash</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</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>
      Primary aim is to evaluate the effect of blood transfusion on oxidant-antioxidant status in&#xD;
      premature neonates. Secondary aim is to assess the effect of the age of transfused red blood&#xD;
      cells on the biological markers of oxidative stress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oxidant-antioxidant status will be assessed by measuring total antioxidant capacity (TAC) and&#xD;
      malondialdehyde (MDA), as well as antioxidant minerals, in 65 term and near-term neonates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2018</start_date>
  <completion_date type="Actual">February 26, 2020</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</primary_completion_date>
  <phase>Early Phase 1</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>Health Services Research</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>malondialdehyde</measure>
    <time_frame>2-3 hours posttransfusion</time_frame>
    <description>MDA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>total antioxidant capacity</measure>
    <time_frame>2-3 hours posttransfusion</time_frame>
    <description>TAC</description>
  </primary_outcome>
  <primary_outcome>
    <measure>serum Copper</measure>
    <time_frame>2-3 hours posttransfusion</time_frame>
    <description>s.Cu</description>
  </primary_outcome>
  <primary_outcome>
    <measure>serum Zinc</measure>
    <time_frame>2-3 hours posttransfusion</time_frame>
    <description>s.Zn</description>
  </primary_outcome>
  <primary_outcome>
    <measure>serum magnesium</measure>
    <time_frame>2-3 hours posttransfusion</time_frame>
    <description>s.Mg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>serum iron</measure>
    <time_frame>2-3 hours posttransfusion</time_frame>
    <description>s.Fe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>serum Calcium</measure>
    <time_frame>2-3 hours posttransfusion</time_frame>
    <description>s.Ca</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Blood Transfusion Complication</condition>
  <condition>Oxidative Stress</condition>
  <arm_group>
    <arm_group_label>Fresh PRBCs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Neonates will receive fresh packed red blood cells transfusion within 7 days of donation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Old PRBCs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Neonates will receive fresh packed red blood cells transfusion older than 7 days yet within the standard range accepted universally will be transfused to this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>packed red blood cells transfusion</intervention_name>
    <description>packed red blood cells transfusion</description>
    <arm_group_label>Fresh PRBCs</arm_group_label>
    <arm_group_label>Old PRBCs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Premature neonates ≤36 weeks in need for blood transfusion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Critically ill neonates.(perinatal asphaxia,on high setting mechanical&#xD;
             ventilation,different types of shock eg ;septic shock and major congenital anomalies)&#xD;
&#xD;
          -  Extremely low birth weight neonates(&lt;1000gm birth weight )&#xD;
&#xD;
          -  Recipient of blood transfusion before enrollment in the study.&#xD;
&#xD;
          -  Neonates planned for exchange transfusion .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Weeks</minimum_age>
    <maximum_age>37 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rania A. El-Farrash, M.D</last_name>
    <role>Study Director</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rania Farrash</name>
      <address>
        <city>Cairo</city>
        <zip>11381</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Rania Ali El-Farrash</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Transfusion Reaction</mesh_term>
  </condition_browse>
  <!-- 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/NCT03767361
org study id: MS2015
nct id: NCT03767361
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Primary aim is to evaluate the effect of blood transfusion on oxidant-antioxidant status in
      premature neonates. Secondary aim is to assess the effect of the age of transfused red blood
      cells on the biological markers of oxidative stress.
Oxidant-antioxidant status will be assessed by measuring total antioxidant capacity (TAC) and
      malondialdehyde (MDA), as well as antioxidant minerals, in 65 term and near-term neonates.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: malondialdehyde
time frame: 2-3 hours posttransfusion
description: MDA
measure: total antioxidant capacity
time frame: 2-3 hours posttransfusion
description: TAC
measure: serum Copper
time frame: 2-3 hours posttransfusion
description: s.Cu
measure: serum Zinc
time frame: 2-3 hours posttransfusion
description: s.Zn
measure: serum magnesium
time frame: 2-3 hours posttransfusion
description: s.Mg
measure: serum iron
time frame: 2-3 hours posttransfusion
description: s.Fe
measure: serum Calcium
time frame: 2-3 hours posttransfusion
description: s.Ca
arm group label: Fresh PRBCs
arm group type: Active Comparator
description: Neonates will receive fresh packed red blood cells transfusion within 7 days of donation
arm group label: Old PRBCs
arm group type: Active Comparator
description: Neonates will receive fresh packed red blood cells transfusion older than 7 days yet within the standard range accepted universally will be transfused to this group.
intervention type: Biological
intervention name: packed red blood cells transfusion
description: packed red blood cells transfusion
arm group label: Fresh PRBCs
arm group label: Old PRBCs
criteria: 
gender: All
minimum age: 35 Weeks
maximum age: 37 Weeks
healthy volunteers: No
last name: Rania A. El-Farrash, M.D
role: Study Director
affiliation: Ain Shams University
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Ain Shams University
investigator full name: Rania Ali El-Farrash
investigator title: Clinical Professor
mesh term: Transfusion Reaction