<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/NCT04433923</url>
  </required_header>
  <id_info>
    <org_study_id>MansouraU004</org_study_id>
    <nct_id>NCT04433923</nct_id>
  </id_info>
  <brief_title>Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants</brief_title>
  <official_title>Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants: Randomised Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      prospective single center pilot randomized open label clinical trial, conducted at the&#xD;
      Neonatal care unit of Mansoura University Children's To assess the efficacy and safety of&#xD;
      aluminum foil use in combination with phototherapy compared with phototherapy alone for&#xD;
      pathological unconjugated hyperbilirubinaemia in full term newborn We enrolled 234 infants in&#xD;
      the study who fulfilled the inclusion criteria and were randomly assigned to treatment&#xD;
      groups, either conventional phototherapy with aluminum foil or conventional phototherapy&#xD;
      alone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 1, 2016</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <primary_purpose>Treatment</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Total serum bilirubin</measure>
    <time_frame>8 hours of treatment</time_frame>
    <description>measurement of Total serum bilirubin (mg/dl)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total serum bilirubin</measure>
    <time_frame>24 hours of treatment</time_frame>
    <description>measurement of Total serum bilirubin (mg/dl)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total serum bilirubin</measure>
    <time_frame>48 hours of treatment</time_frame>
    <description>measurement of Total serum bilirubin (mg/dl)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>duration of photo therapy</measure>
    <time_frame>average 48 hours</time_frame>
    <description>duration of photo therapy in hours</description>
  </secondary_outcome>
  <number_of_arms>2</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>Phototherapy with aluminum foil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GROUP2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Phototherapy without aluminum foil</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Phototherapy with aluminum foil</intervention_name>
    <arm_group_label>GROUP1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Phototherapy without aluminum foil</intervention_name>
    <arm_group_label>GROUP2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Appropriate for gestational age full-term infants with pathological unconjugated&#xD;
             hyperbilirubinaemia who are candidate for photo therapy according to American academy&#xD;
             guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preterm infants, newborn infant with congenital malformations, conjugated&#xD;
             hyperbilirubinamia, small for gestational age, in need of exchange transfusion, and&#xD;
             skin abrasions or infections&#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>June 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 13, 2020</last_update_submitted>
  <last_update_submitted_qc>June 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 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>
  <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>
  <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/NCT04433923
org study id: MansouraU004
nct id: NCT04433923
lead sponsor: 
is fda regulated drug: No
prospective single center pilot randomized open label clinical trial, conducted at the
      Neonatal care unit of Mansoura University Children's To assess the efficacy and safety of
      aluminum foil use in combination with phototherapy compared with phototherapy alone for
      pathological unconjugated hyperbilirubinaemia in full term newborn We enrolled 234 infants in
      the study who fulfilled the inclusion criteria and were randomly assigned to treatment
      groups, either conventional phototherapy with aluminum foil or conventional phototherapy
      alone.
primary purpose: Treatment
measure: Total serum bilirubin
time frame: 8 hours of treatment
description: measurement of Total serum bilirubin (mg/dl)
measure: Total serum bilirubin
time frame: 24 hours of treatment
description: measurement of Total serum bilirubin (mg/dl)
measure: Total serum bilirubin
time frame: 48 hours of treatment
description: measurement of Total serum bilirubin (mg/dl)
measure: duration of photo therapy
time frame: average 48 hours
description: duration of photo therapy in hours
arm group label: GROUP1
arm group type: Active Comparator
description: Phototherapy with aluminum foil
arm group label: GROUP2
arm group type: Placebo Comparator
description: Phototherapy without aluminum foil
intervention type: Device
intervention name: Phototherapy with aluminum foil
arm group label: GROUP1
intervention type: Device
intervention name: Phototherapy without aluminum foil
arm group label: GROUP2
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
sharing ipd: Undecided