<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/NCT03296059</url>
  </required_header>
  <id_info>
    <org_study_id>201732</org_study_id>
    <nct_id>NCT03296059</nct_id>
  </id_info>
  <brief_title>Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates</brief_title>
  <official_title>Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</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>
      Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.&#xD;
&#xD;
      The death rate is over 50%.There are no special treatments for acute respiratory distress&#xD;
      syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute respiratory distress syndrome (ARDS) is one of the serious complications in critically&#xD;
      ill neonates. It can result in severe hypoxemia refractory to mechanical ventilation. There&#xD;
      are few options for mechanical ventilation for such situations such as high frequency&#xD;
      oscillation ventilation and extracorporeal membrane oxygenation. The aim of the present study&#xD;
      is to determine whether transfusion of red blood cells can decrease the mortality in neonate&#xD;
      with ARDS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>death rate</measure>
    <time_frame>within 100 days</time_frame>
    <description>neonate died due to respiratory failure</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Red Blood Cells(RBC)</condition>
  <condition>Acute Respiratory Distress Syndrome (ARDS)</condition>
  <arm_group>
    <arm_group_label>RBC transfusion with conventional treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Besides conventional treatment,neonates diagnosed with ARDS is treated with RBC transfusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>neonates diagnosed with ARDS is treated with conventional treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional treatment with RBC transfusion</intervention_name>
    <description>Besides conventional treatment, neonates is given RBC transfusion.</description>
    <arm_group_label>RBC transfusion with conventional treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional treatment</intervention_name>
    <description>neonates is treated with conventional treatment.</description>
    <arm_group_label>conventional treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed with neonatal ARDS.&#xD;
&#xD;
          -  informed parental consent has been obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  major congenital malformations or complex congenital heart disease&#xD;
&#xD;
          -  transferred out of the neonatal intensive care unit without treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Minutes</minimum_age>
    <maximum_age>1 Month</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shi Yuan, PhD,MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ma Juan, MD</last_name>
    <phone>13508300283</phone>
    <email>476679422@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ma Juan, MD</last_name>
    <phone>1388559467</phone>
    <email>476679422@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400042</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shi Yuan, PhD,MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>October 23, 2022</last_update_submitted>
  <last_update_submitted_qc>October 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</investigator_affiliation>
    <investigator_full_name>Ma Juan</investigator_full_name>
    <investigator_title>director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03296059
org study id: 201732
nct id: NCT03296059
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.

      The death rate is over 50%.There are no special treatments for acute respiratory distress
      syndrome.
Acute respiratory distress syndrome (ARDS) is one of the serious complications in critically
      ill neonates. It can result in severe hypoxemia refractory to mechanical ventilation. There
      are few options for mechanical ventilation for such situations such as high frequency
      oscillation ventilation and extracorporeal membrane oxygenation. The aim of the present study
      is to determine whether transfusion of red blood cells can decrease the mortality in neonate
      with ARDS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: death rate
time frame: within 100 days
description: neonate died due to respiratory failure
arm group label: RBC transfusion with conventional treatment
arm group type: Experimental
description: Besides conventional treatment,neonates diagnosed with ARDS is treated with RBC transfusion.
arm group label: conventional treatment
arm group type: Active Comparator
description: neonates diagnosed with ARDS is treated with conventional treatment.
intervention type: Other
intervention name: conventional treatment with RBC transfusion
description: Besides conventional treatment, neonates is given RBC transfusion.
arm group label: RBC transfusion with conventional treatment
intervention type: Other
intervention name: conventional treatment
description: neonates is treated with conventional treatment.
arm group label: conventional treatment
criteria: 
gender: All
minimum age: 30 Minutes
maximum age: 1 Month
healthy volunteers: No
last name: Shi Yuan, PhD,MD
role: Principal Investigator
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
last name: Ma Juan, MD
phone: 13508300283
email: 476679422@qq.com
last name: Ma Juan, MD
phone: 1388559467
email: 476679422@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
investigator full name: Ma Juan
investigator title: director
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Syndrome
sharing ipd: No