<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/NCT03265782</url>
  </required_header>
  <id_info>
    <org_study_id>43214321</org_study_id>
    <nct_id>NCT03265782</nct_id>
  </id_info>
  <brief_title>Paracetamol Versus Ibuprofen for PDA Closure</brief_title>
  <official_title>Comparison Between the Effect of Oral Paracetamol Versus Oral Ibuprofen in the Treatment of Patent Ductus Arteriosus in Preterm and Low Birth Weight Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in&#xD;
      treatment of Patent Ductus Arteriosus (PDA) in premature infants&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A pilot study through which we have studied efficacy and safety of oral paracetamol and oral&#xD;
      ibuprofen in treatment of hemodyamically significant pda in preterm neonates. 30 preterm&#xD;
      neonates were included in the study 15 per each group. echo was done in the beginning and&#xD;
      during treatment with both drugs to follow up the closure of the duct.&#xD;
&#xD;
      Ibuprofen was given as 10 mg/kg/dose in the 1st day followed by 5 mg/kg/dose in the 2nd and&#xD;
      3rd days with follow up echo was done after finishing the course paracetamol was given as 15&#xD;
      mglkg/6 hrs for three days with follow up echo to check the ductal closure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 2015</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2017</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>closure of PDA</measure>
    <time_frame>6 days</time_frame>
    <description>Echo confirmed closure</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Patent Ductus Arteriosus</condition>
  <arm_group>
    <arm_group_label>ibuprofen group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treatment of pda with oral ibuprofen with a loading dose 10 mg/kg/ds in the first day followed by 5 mg/kg/ds in the second ant third days then a follow up echo is done</description>
  </arm_group>
  <arm_group>
    <arm_group_label>paracetamol group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treatment of pda with oral paracetamol with dose of 15 mg/kg/ds every 6 hours for 3 days then a follow up echo is done</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ibuprofen</intervention_name>
    <description>drug was adminstred with a loading dose 10 mg/kg/day followed by 5 mg/kg/day in 2 doses with 24 hrs apart for 3 days</description>
    <arm_group_label>ibuprofen group</arm_group_label>
    <other_name>brufen</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>paracetamol</intervention_name>
    <description>drug was administred for 3 consequetive days in a dosev 15 mg/kg/dose every 6 hrs and follow up echo was done after 3 days</description>
    <arm_group_label>paracetamol group</arm_group_label>
    <other_name>cetal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Gestational age ≤ 35 weeks&#xD;
&#xD;
          2. Aged 2-7 days with color Doppler echocardiographic evidence of PDA&#xD;
&#xD;
          3. Urine output more than 1 ml/kg/hr&#xD;
&#xD;
          4. Creatinine concentration level less than 1.8 mg/dl&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Neonates who have one or more of the following criteria were excluded from the study:&#xD;
&#xD;
          1. Congenital heart diseases of any type including&#xD;
&#xD;
               -  Pulmonary stenosis&#xD;
&#xD;
               -  Anomalus in pulmonary venous drainage&#xD;
&#xD;
               -  Ventricular septal defect&#xD;
&#xD;
          2. Major congenital anomalies as hydrops fetalis&#xD;
&#xD;
          3. Low platelets count (less than 60, 000/mm3)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>28 Weeks</minimum_age>
    <maximum_age>35 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>March 10, 2015</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Rania Ali El-Farrash</investigator_full_name>
    <investigator_title>pricipal investigator</investigator_title>
  </responsible_party>
  <keyword>efficacy</keyword>
  <keyword>safety</keyword>
  <keyword>paracetamol</keyword>
  <keyword>ibuprofen</keyword>
  <keyword>PDA</keyword>
  <keyword>preterms</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>
  <!-- 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/NCT03265782
org study id: 43214321
nct id: NCT03265782
lead sponsor: 
has dmc: Yes
Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in
      treatment of Patent Ductus Arteriosus (PDA) in premature infants
A pilot study through which we have studied efficacy and safety of oral paracetamol and oral
      ibuprofen in treatment of hemodyamically significant pda in preterm neonates. 30 preterm
      neonates were included in the study 15 per each group. echo was done in the beginning and
      during treatment with both drugs to follow up the closure of the duct.

      Ibuprofen was given as 10 mg/kg/dose in the 1st day followed by 5 mg/kg/dose in the 2nd and
      3rd days with follow up echo was done after finishing the course paracetamol was given as 15
      mglkg/6 hrs for three days with follow up echo to check the ductal closure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: closure of PDA
time frame: 6 days
description: Echo confirmed closure
arm group label: ibuprofen group
arm group type: Experimental
description: treatment of pda with oral ibuprofen with a loading dose 10 mg/kg/ds in the first day followed by 5 mg/kg/ds in the second ant third days then a follow up echo is done
arm group label: paracetamol group
arm group type: Experimental
description: treatment of pda with oral paracetamol with dose of 15 mg/kg/ds every 6 hours for 3 days then a follow up echo is done
intervention type: Drug
intervention name: ibuprofen
description: drug was adminstred with a loading dose 10 mg/kg/day followed by 5 mg/kg/day in 2 doses with 24 hrs apart for 3 days
arm group label: ibuprofen group
other name: brufen
intervention type: Drug
intervention name: paracetamol
description: drug was administred for 3 consequetive days in a dosev 15 mg/kg/dose every 6 hrs and follow up echo was done after 3 days
arm group label: paracetamol group
other name: cetal
criteria: 
gender: All
minimum age: 28 Weeks
maximum age: 35 Weeks
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Rania Ali El-Farrash
investigator title: pricipal investigator
mesh term: Ductus Arteriosus, Patent
mesh term: Acetaminophen
mesh term: Ibuprofen