<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/NCT03805165</url>
  </required_header>
  <id_info>
    <org_study_id>Guangdong WCH</org_study_id>
    <nct_id>NCT03805165</nct_id>
  </id_info>
  <brief_title>Hour-specific Transcutaneous Bilirubin in Healthy Term and Near-term Newborns of China</brief_title>
  <official_title>Hour-specific Transcutaneous Bilirubin in Healthy Term and Near-term Newborns of China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Women and Children Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Women and Children Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Make a neonatal jaundiced nomogram on Chinese jaundice data by joinning the major neonate&#xD;
      centers all around China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Jaundice in common amount Chinese newborn population. The neonatal jaundice guildline was&#xD;
      made base on the AAP. guideline. Chinese newborn have their jaundice follow up and treatment&#xD;
      plans make base on American neonatel jaundice data. Our group are now planning to have our&#xD;
      own neonatel jaundice data by joinning the major neonate centers all around China. A neonatal&#xD;
      jaundiced nomogram would be made base on Chinese neonatel jaundice data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hour-specific Transcutaneous Bilirubin Level</measure>
    <time_frame>1 year</time_frame>
    <description>make neonatal jaundiced nomogram base on the hour-specific transcutaneous bilirubin data</description>
  </primary_outcome>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Jaundice, Neonatal</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Term and near term newborns, whos gestational age was more than 35 weeks(≥35)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        gestational age more than 35 weeks(≥35) -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        all kinds of congenital diseases, infants with pathologic jaundice&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>7 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jie Yang</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>511442</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangdong Women and Children Hospital</investigator_affiliation>
    <investigator_full_name>yangjie</investigator_full_name>
    <investigator_title>Director of neonatology of GuangdongWCH</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>
  <!-- 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/NCT03805165
org study id: Guangdong WCH
nct id: NCT03805165
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Make a neonatal jaundiced nomogram on Chinese jaundice data by joinning the major neonate
      centers all around China.
Jaundice in common amount Chinese newborn population. The neonatal jaundice guildline was
      made base on the AAP. guideline. Chinese newborn have their jaundice follow up and treatment
      plans make base on American neonatel jaundice data. Our group are now planning to have our
      own neonatel jaundice data by joinning the major neonate centers all around China. A neonatal
      jaundiced nomogram would be made base on Chinese neonatel jaundice data.
observational model: Other
time perspective: Other
measure: Hour-specific Transcutaneous Bilirubin Level
time frame: 1 year
description: make neonatal jaundiced nomogram base on the hour-specific transcutaneous bilirubin data
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 7 Days
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangdong Women and Children Hospital
investigator full name: yangjie
investigator title: Director of neonatology of GuangdongWCH
mesh term: Jaundice, Neonatal
mesh term: Jaundice