<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/NCT04415554</url>
  </required_header>
  <id_info>
    <org_study_id>CMC-19-0110-CTIL</org_study_id>
    <nct_id>NCT04415554</nct_id>
  </id_info>
  <brief_title>Aminoglycosides and Duct</brief_title>
  <official_title>The Effect of Aminoglycosides on Ductus in Preterm Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carmel Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carmel Medical Center</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 the study is to assess the effect of aminoglycoside treatment on ductal closure in&#xD;
      preterms&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2021</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ductal closure</measure>
    <time_frame>3 weeks</time_frame>
    <description>closure of ductus arteriosus</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Patent Ductus Arteriosus</condition>
  <arm_group>
    <arm_group_label>exposure to aminoglicosides</arm_group_label>
    <description>preterm receiving aminoglycosides</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non exposure to aminoglycosides</arm_group_label>
    <description>preterm not receiving aminoglycosides</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>echocardiography</intervention_name>
    <description>echocardiography exam of the infant</description>
    <arm_group_label>exposure to aminoglicosides</arm_group_label>
    <arm_group_label>non exposure to aminoglycosides</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        preterm infants hospitalized in NICU&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        infants born at or above 32 weeks of gestation&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infants who are unlikely to survive or have congenital heart defects&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Minutes</minimum_age>
    <maximum_age>3 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>February 7, 2021</last_update_submitted>
  <last_update_submitted_qc>February 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Carmel Medical Center</investigator_affiliation>
    <investigator_full_name>Ayala Gover</investigator_full_name>
    <investigator_title>Neonatologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ductus Arteriosus, Patent</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/NCT04415554
org study id: CMC-19-0110-CTIL
nct id: NCT04415554
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to assess the effect of aminoglycoside treatment on ductal closure in
      preterms
observational model: Case-Control
time perspective: Prospective
measure: ductal closure
time frame: 3 weeks
description: closure of ductus arteriosus
arm group label: exposure to aminoglicosides
description: preterm receiving aminoglycosides
arm group label: non exposure to aminoglycosides
description: preterm not receiving aminoglycosides
intervention type: Diagnostic Test
intervention name: echocardiography
description: echocardiography exam of the infant
arm group label: exposure to aminoglicosides
arm group label: non exposure to aminoglycosides
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Minutes
maximum age: 3 Weeks
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Carmel Medical Center
investigator full name: Ayala Gover
investigator title: Neonatologist
mesh term: Ductus Arteriosus, Patent