<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/NCT03237715</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT03237715</nct_id>
  </id_info>
  <brief_title>Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants</brief_title>
  <official_title>Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rutgers University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Specific Aim 1: To determine total serum bilirubin (TSB) and unbound bilirubin (Bf) levels in&#xD;
      term and late preterm infants during the first week of life.&#xD;
&#xD;
      Specific Aim 2: Measure Bf levels in breast fed and formula fed infants and examine their&#xD;
      relationship to unbound fatty acid (FFAu) levels.&#xD;
&#xD;
      Specific Aim 3: To demonstrate that phototherapy results in different changes in TSB and Bf.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Unbound bilirubin levels in term and late preterm infants</measure>
    <time_frame>Two years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Unbound bilirubin levels in breast-fed versus formula-fed term and late preterm infants</measure>
    <time_frame>Two years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of phototherapy on unbound bilirubin levels</measure>
    <time_frame>Two years</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Neonatal Jaundice</condition>
  <arm_group>
    <arm_group_label>Breast fed cohort</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Formula fed cohort</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assessment of unbound bilirubin levels</intervention_name>
    <description>Collection of residual blood for measurement of unbound bilirubin</description>
    <arm_group_label>Breast fed cohort</arm_group_label>
    <arm_group_label>Formula fed cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Term and late preterm infants admitted to regular care nursery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Term and late-preterm infants admitted to the regular care nursery of Robert Wood&#xD;
             Johnson University Hospital will be eligible for the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants suffering from genetic, chromosomal or surgical conditions will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Hours</minimum_age>
    <maximum_age>7 Days</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Robert Wood Johnson University Hospital</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Hegyi, MD</last_name>
      <phone>732-235-8958</phone>
      <email>hegyith@rwjms.rutgers.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>July 31, 2017</last_update_submitted>
  <last_update_submitted_qc>July 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rutgers University</investigator_affiliation>
    <investigator_full_name>Thomas Hegyi</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bilirubin</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/NCT03237715
org study id: 1
nct id: NCT03237715
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Specific Aim 1: To determine total serum bilirubin (TSB) and unbound bilirubin (Bf) levels in
      term and late preterm infants during the first week of life.

      Specific Aim 2: Measure Bf levels in breast fed and formula fed infants and examine their
      relationship to unbound fatty acid (FFAu) levels.

      Specific Aim 3: To demonstrate that phototherapy results in different changes in TSB and Bf.
observational model: Case-Control
time perspective: Prospective
measure: Unbound bilirubin levels in term and late preterm infants
time frame: Two years
measure: Unbound bilirubin levels in breast-fed versus formula-fed term and late preterm infants
time frame: Two years
measure: Effect of phototherapy on unbound bilirubin levels
time frame: Two years
arm group label: Breast fed cohort
arm group label: Formula fed cohort
intervention type: Other
intervention name: Assessment of unbound bilirubin levels
description: Collection of residual blood for measurement of unbound bilirubin
arm group label: Breast fed cohort
arm group label: Formula fed cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Hours
maximum age: 7 Days
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rutgers University
investigator full name: Thomas Hegyi
investigator title: Professor
mesh term: Jaundice, Neonatal
mesh term: Jaundice
mesh term: Bilirubin
sharing ipd: No