<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/NCT04418180</url>
  </required_header>
  <id_info>
    <org_study_id>MansouraU003</org_study_id>
    <nct_id>NCT04418180</nct_id>
  </id_info>
  <brief_title>Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants</brief_title>
  <official_title>Fenofibrate as an Adjuvant to Phototherapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants: A Randomized Control Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <brief_summary>
    <textblock>
      Background: Despite widespread phototherapy usage, many newborn infants remain in need of&#xD;
      other lines of invasive therapy such as intravenous immunoglobulins and exchange&#xD;
      transfusions.&#xD;
&#xD;
      Objective: To assess the efficacy and the safety of adding fenofibrate to phototherapy for&#xD;
      treatment of pathological jaundice in full term infants.&#xD;
&#xD;
      Design/Methods: We conducted a double blinded randomized control study on 180 full-term&#xD;
      infants with pathological unconjugated hyperbilirubinemia admitted to the NICU of Mansoura&#xD;
      University Children's Hospital. They were randomly assigned to receive either oral&#xD;
      fenofibrate 10 mg /kg /day for one day or two days or placebo. Primary outcome was total&#xD;
      serum bilirubin values after 12, 24, 36, 48 hours from intervention. Secondary outcomes were&#xD;
      total duration of treatment, need for exchange transfusions and intravenous immunoglobulin,&#xD;
      exclusive breast-feeding on discharge, and adverse effects of fenofibrate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <primary_completion_date type="Actual">December 12, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Total serum bilirubin</measure>
    <time_frame>24 hours of treatment</time_frame>
    <description>measure level of serum total bilirubin (mg/dl)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total serum bilirubin</measure>
    <time_frame>48 hours of treatment</time_frame>
    <description>measure level of serum total bilirubin (mg/dl)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total serum bilirubin</measure>
    <time_frame>72 hours of treatment</time_frame>
    <description>measure level of serum total bilirubin (mg/dl)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>expected 3 days of treatment</time_frame>
    <description>Duration of hospital admission (days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of photo therapy</measure>
    <time_frame>expected 48 hours of treatment</time_frame>
    <description>duration of photo therapy (hours)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <condition>Neonatal Jaundice</condition>
  <arm_group>
    <arm_group_label>GROUP1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>group receiving single dose fenofibrate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GROUP2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>group receiving double dose fenofibrate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GROUP3</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>photo therapy only</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fenofibrate</intervention_name>
    <description>Patients were randomly assigned to receive oral fenofibrate 10 mg/kg/hr</description>
    <arm_group_label>GROUP1</arm_group_label>
    <arm_group_label>GROUP2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>oral distilled water</description>
    <arm_group_label>GROUP3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  we included appropriate for gestational age full-term infants with pathological&#xD;
             unconjugated hyperbilirubinemia who are candidate for phototherapy according to&#xD;
             American academy of pediatrics guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Full term infants with intrauterine growth restriction, congenital malformations,&#xD;
             conjugated hyperbilirubinemia, severe jaundice initially required exchange&#xD;
             transfusion, skin abrasions or infection, and preterm infants were excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>28 Days</maximum_age>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Abd Elazeez Attala Shabaan</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Fenofibrate, Neonatal hyperbilirubinemia, Phototherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Jaundice, Neonatal</mesh_term>
    <mesh_term>Jaundice</mesh_term>
    <mesh_term>Hyperbilirubinemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fenofibrate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04418180
org study id: MansouraU003
nct id: NCT04418180
lead sponsor: 
Background: Despite widespread phototherapy usage, many newborn infants remain in need of
      other lines of invasive therapy such as intravenous immunoglobulins and exchange
      transfusions.

      Objective: To assess the efficacy and the safety of adding fenofibrate to phototherapy for
      treatment of pathological jaundice in full term infants.

      Design/Methods: We conducted a double blinded randomized control study on 180 full-term
      infants with pathological unconjugated hyperbilirubinemia admitted to the NICU of Mansoura
      University Children's Hospital. They were randomly assigned to receive either oral
      fenofibrate 10 mg /kg /day for one day or two days or placebo. Primary outcome was total
      serum bilirubin values after 12, 24, 36, 48 hours from intervention. Secondary outcomes were
      total duration of treatment, need for exchange transfusions and intravenous immunoglobulin,
      exclusive breast-feeding on discharge, and adverse effects of fenofibrate.
measure: Total serum bilirubin
time frame: 24 hours of treatment
description: measure level of serum total bilirubin (mg/dl)
measure: Total serum bilirubin
time frame: 48 hours of treatment
description: measure level of serum total bilirubin (mg/dl)
measure: Total serum bilirubin
time frame: 72 hours of treatment
description: measure level of serum total bilirubin (mg/dl)
measure: length of hospital stay
time frame: expected 3 days of treatment
description: Duration of hospital admission (days)
measure: duration of photo therapy
time frame: expected 48 hours of treatment
description: duration of photo therapy (hours)
arm group label: GROUP1
arm group type: Active Comparator
description: group receiving single dose fenofibrate
arm group label: GROUP2
arm group type: Active Comparator
description: group receiving double dose fenofibrate
arm group label: GROUP3
arm group type: Placebo Comparator
description: photo therapy only
intervention type: Drug
intervention name: Fenofibrate
description: Patients were randomly assigned to receive oral fenofibrate 10 mg/kg/hr
arm group label: GROUP1
arm group label: GROUP2
intervention type: Drug
intervention name: Placebo
description: oral distilled water
arm group label: GROUP3
criteria: 
gender: All
minimum age: N/A
maximum age: 28 Days
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Abd Elazeez Attala Shabaan
investigator title: Professor
mesh term: Jaundice, Neonatal
mesh term: Jaundice
mesh term: Hyperbilirubinemia
mesh term: Fenofibrate
sharing ipd: Undecided