<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/NCT03289390</url>
  </required_header>
  <id_info>
    <org_study_id>4846</org_study_id>
    <nct_id>NCT03289390</nct_id>
  </id_info>
  <brief_title>Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications</brief_title>
  <official_title>Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the use of acetaminophen in preterm infants when a patent ductus&#xD;
      arteriosus (PDA) is of concern. We will perform two simultaneous prospective observational&#xD;
      studies over a 3 year period. The first will be of infants with clinically significant PDAs&#xD;
      beyond 14 days of life who are medically treated with acetaminophen as a means to avoid&#xD;
      surgical ligation, and the second will be of infants who received acetaminophen for a PDA&#xD;
      closure during the first 2 weeks of life as a result of ibuprofen, the current standard of&#xD;
      care in our NICU, contraindication due to medical status.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </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>
  <primary_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>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">11</enrollment>
  <condition>Patent Ductus Arteriosus</condition>
  <arm_group>
    <arm_group_label>Acetaminophen to close PDA</arm_group_label>
    <description>Infants with PDA treated with acetaminophen beyond 14 days of life or in whom acetaminophen is used due to contraindication to ibuprofen</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>Acetaminophen given at discretion of medical team for PDA treatment. Research team to evaluate pre and post laboratory values and echocardiograms.</description>
    <arm_group_label>Acetaminophen to close PDA</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Premature infants born between 23 0/7 weeks to 29 6/7 weeks gestational age.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants born at 23 0/7 to 29 6/7 weeks gestation, with PDA determined by medical team&#xD;
             to need treatment and infant is beyond 14 days of life.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Congenital heart disease Pneumonia Pulmonary hypertension Pulmonary hemorrhage ALT and&#xD;
             AST ≥ 2X the upper limit of normal (=AST&gt; 150 U/L, ALT&gt;90 U/L) Sepsis/meningitis&#xD;
             Abnormal chromosomes Hydrops Major congenital malformations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>23 Weeks</minimum_age>
    <maximum_age>30 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Albany Medical Center</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>
  <reference>
    <citation>El-Mashad AE, El-Mahdy H, El Amrousy D, Elgendy M. Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates. Eur J Pediatr. 2017 Feb;176(2):233-240. doi: 10.1007/s00431-016-2830-7. Epub 2016 Dec 21.</citation>
    <PMID>28004188</PMID>
  </reference>
  <reference>
    <citation>EL-Khuffash A, James AT, Cleary A, Semberova J, Franklin O, Miletin J. Late medical therapy of patent ductus arteriosus using intravenous paracetamol. Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F253-6. doi: 10.1136/archdischild-2014-307930. Epub 2015 Feb 4.</citation>
    <PMID>25653299</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>January 8, 2020</last_update_submitted>
  <last_update_submitted_qc>January 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Albany Medical College</investigator_affiliation>
    <investigator_full_name>Ronnelle King</investigator_full_name>
    <investigator_title>MD</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
  </intervention_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/NCT03289390
org study id: 4846
nct id: NCT03289390
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the use of acetaminophen in preterm infants when a patent ductus
      arteriosus (PDA) is of concern. We will perform two simultaneous prospective observational
      studies over a 3 year period. The first will be of infants with clinically significant PDAs
      beyond 14 days of life who are medically treated with acetaminophen as a means to avoid
      surgical ligation, and the second will be of infants who received acetaminophen for a PDA
      closure during the first 2 weeks of life as a result of ibuprofen, the current standard of
      care in our NICU, contraindication due to medical status.
observational model: Cohort
time perspective: Prospective
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 to close PDA
description: Infants with PDA treated with acetaminophen beyond 14 days of life or in whom acetaminophen is used due to contraindication to ibuprofen
intervention type: Drug
intervention name: Acetaminophen
description: Acetaminophen given at discretion of medical team for PDA treatment. Research team to evaluate pre and post laboratory values and echocardiograms.
arm group label: Acetaminophen to close PDA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 23 Weeks
maximum age: 30 Weeks
healthy volunteers: No
facility: 
country: United States
citation: El-Mashad AE, El-Mahdy H, El Amrousy D, Elgendy M. Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates. Eur J Pediatr. 2017 Feb;176(2):233-240. doi: 10.1007/s00431-016-2830-7. Epub 2016 Dec 21.
PMID: 28004188
citation: EL-Khuffash A, James AT, Cleary A, Semberova J, Franklin O, Miletin J. Late medical therapy of patent ductus arteriosus using intravenous paracetamol. Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F253-6. doi: 10.1136/archdischild-2014-307930. Epub 2015 Feb 4.
PMID: 25653299
responsible party type: Principal Investigator
investigator affiliation: Albany Medical College
investigator full name: Ronnelle King
investigator title: MD
mesh term: Ductus Arteriosus, Patent
mesh term: Acetaminophen
sharing ipd: No