<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/NCT03008876</url>
  </required_header>
  <id_info>
    <org_study_id>4683</org_study_id>
    <nct_id>NCT03008876</nct_id>
  </id_info>
  <brief_title>IV Acetaminophen and Patent Ductus Arteriosus</brief_title>
  <official_title>The Efficacy of IV Acetaminophen on Patent Ductus Arteriosus Closure in Preterm Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albany Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Albany Medical College</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV&#xD;
      ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm&#xD;
      infants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of PDA Closure</measure>
    <time_frame>3 days</time_frame>
    <description>PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in PDA size</measure>
    <time_frame>3 days</time_frame>
    <description>Size of PDA will be measured by echocardiography to determine if the size has changed after treatment is complete</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Patent Ductus Arteriosus</condition>
  <arm_group>
    <arm_group_label>acetaminophen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group of patients randomized to receive acetaminophen to treat their PDA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ibuprofen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group of patients randomized to receive ibuprofen to treat their PDA</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>infants receive acetaminophen for treatment of their PDA</description>
    <arm_group_label>acetaminophen</arm_group_label>
    <other_name>tylenol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <description>infants receive ibuprofen, standard of care in our unit, for treatment of a PDA</description>
    <arm_group_label>ibuprofen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  preterm infants 23-30 weeks gestation,&#xD;
&#xD;
          -  PDA requiring treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infection,&#xD;
&#xD;
          -  congenital heart disease,&#xD;
&#xD;
          -  genetic syndrome,&#xD;
&#xD;
          -  NEC,&#xD;
&#xD;
          -  pulmonary hypertension,&#xD;
&#xD;
          -  hydrops,&#xD;
&#xD;
          -  intestinal perforation,&#xD;
&#xD;
          -  grade 3 or 4 IVH,&#xD;
&#xD;
          -  serum creatinine &gt;1.5,&#xD;
&#xD;
          -  previous treatment with a COX inhibitor.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Minute</minimum_age>
    <maximum_age>2 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Albany Medical Center Neonatal Intesive Care Unit</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>July 5, 2019</last_update_submitted>
  <last_update_submitted_qc>July 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Albany Medical College</investigator_affiliation>
    <investigator_full_name>Kate Tauber</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>neonate</keyword>
  <keyword>acetaminophen</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ductus Arteriosus, Patent</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Ibuprofen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 2, 2023</submitted>
    <returned>March 27, 2023</returned>
  </pending_results>
  <!-- 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/NCT03008876
org study id: 4683
nct id: NCT03008876
lead sponsor: 
has dmc: No
This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV
      ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm
      infants.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of PDA Closure
time frame: 3 days
description: PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.
measure: Change in PDA size
time frame: 3 days
description: Size of PDA will be measured by echocardiography to determine if the size has changed after treatment is complete
arm group label: acetaminophen
arm group type: Experimental
description: Group of patients randomized to receive acetaminophen to treat their PDA
arm group label: ibuprofen
arm group type: Active Comparator
description: Group of patients randomized to receive ibuprofen to treat their PDA
intervention type: Drug
intervention name: Acetaminophen
description: infants receive acetaminophen for treatment of their PDA
arm group label: acetaminophen
other name: tylenol
intervention type: Drug
intervention name: Ibuprofen
description: infants receive ibuprofen, standard of care in our unit, for treatment of a PDA
arm group label: ibuprofen
criteria: 
gender: All
minimum age: 1 Minute
maximum age: 2 Weeks
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Albany Medical College
investigator full name: Kate Tauber
investigator title: Assistant Professor
mesh term: Ductus Arteriosus, Patent
mesh term: Acetaminophen
mesh term: Ibuprofen
sharing ipd: No
submitted: March 2, 2023
returned: March 27, 2023