<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/NCT03266913</url>
  </required_header>
  <id_info>
    <org_study_id>4889</org_study_id>
    <nct_id>NCT03266913</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia</brief_title>
  <official_title>Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hormozgan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hormozgan University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neonatal Jaundice occurs in 60% of term infants and 80% of premature infants. Although it is&#xD;
      transient, it is associated with high rate of readmission of patients in the first week of&#xD;
      infancy. Neonatal jaundice can cause neurological complications and kernicterus. Considering&#xD;
      the fact that there have been a lot of studies on probiotic role in management of necrotizing&#xD;
      enterocolitis (NEC) and few studies on their role in neonatal jaundice, we carried out this&#xD;
      study to determine the efficacy and safety of probiotics in neonatal hyperbilirubinemia in&#xD;
      infants hospitalized in children hospital in Bandar Abbas.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">November 1, 2017</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2017</primary_completion_date>
  <phase>Phase 3</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of phototherapy</measure>
    <time_frame>6 days</time_frame>
    <description>Duration of phototherapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Discharge rate</measure>
    <time_frame>6 days</time_frame>
    <description>percentage of infants discharged from the hospital at 2nd, 3rd, 4th, and 5th days of admission</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">126</enrollment>
  <condition>Hyperbilirubinemia, Neonatal</condition>
  <arm_group>
    <arm_group_label>Probiotic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Routine phototherapy plus probiotic oral drops at the dose of 10 drops daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No probiotic</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Routine phototherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Probiotic</intervention_name>
    <description>Probiotics drop</description>
    <arm_group_label>Probiotic</arm_group_label>
    <other_name>PediLact</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 2 and 28 days old&#xD;
&#xD;
          -  Having jaundice&#xD;
&#xD;
          -  Gestational age between 35-42 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 2 days or more than 28 days old&#xD;
&#xD;
          -  Gestational age out of the range of 35-42 weeks&#xD;
&#xD;
          -  Infants whose parents refused to cooperate&#xD;
&#xD;
          -  Patients with sepsis and other comorbid conditions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Days</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rakhshaneh Goodarzi, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hormozgan University of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rakhshaneh Goodarzi, M.D</last_name>
    <phone>+989123004060</phone>
    <email>rakhshanehgoodarzi@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Children hospital</name>
      <address>
        <city>Bandar Abbas</city>
        <state>Hormozgan</state>
        <zip>763</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rakhshaneh Goodarzi</last_name>
      <phone>+989123004060</phone>
      <email>rakhshanehgoodarzi@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hormozgan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Hamidreza Mahboobi</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperbilirubinemia, Neonatal</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/NCT03266913
org study id: 4889
nct id: NCT03266913
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Neonatal Jaundice occurs in 60% of term infants and 80% of premature infants. Although it is
      transient, it is associated with high rate of readmission of patients in the first week of
      infancy. Neonatal jaundice can cause neurological complications and kernicterus. Considering
      the fact that there have been a lot of studies on probiotic role in management of necrotizing
      enterocolitis (NEC) and few studies on their role in neonatal jaundice, we carried out this
      study to determine the efficacy and safety of probiotics in neonatal hyperbilirubinemia in
      infants hospitalized in children hospital in Bandar Abbas.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Duration of phototherapy
time frame: 6 days
description: Duration of phototherapy
measure: Discharge rate
time frame: 6 days
description: percentage of infants discharged from the hospital at 2nd, 3rd, 4th, and 5th days of admission
arm group label: Probiotic
arm group type: Active Comparator
description: Routine phototherapy plus probiotic oral drops at the dose of 10 drops daily
arm group label: No probiotic
arm group type: No Intervention
description: Routine phototherapy
intervention type: Drug
intervention name: Probiotic
description: Probiotics drop
arm group label: Probiotic
other name: PediLact
criteria: 
gender: All
minimum age: 2 Days
maximum age: 28 Days
healthy volunteers: No
last name: Rakhshaneh Goodarzi, M.D
role: Principal Investigator
affiliation: Hormozgan University of Medical Sciences
last name: Rakhshaneh Goodarzi, M.D
phone: +989123004060
email: rakhshanehgoodarzi@yahoo.com
facility: 
status: Recruiting
contact: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Hormozgan University of Medical Sciences
investigator full name: Hamidreza Mahboobi
investigator title: Principle Investigator
mesh term: Hyperbilirubinemia, Neonatal
mesh term: Hyperbilirubinemia
sharing ipd: Undecided