<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/NCT03824990</url>
  </required_header>
  <id_info>
    <org_study_id>NMU-FY2018-72</org_study_id>
    <nct_id>NCT03824990</nct_id>
  </id_info>
  <brief_title>Multi-center Clinical Study on Neonatal Hyperbilirubinemia</brief_title>
  <official_title>Multi-center Clinical Study on Early Screening and Treatment of Hyperbilirubinemia of Term and Late-preterm Neonates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>JiLin Women and Children Health Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shandong Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shan Dong Qian Fo Shan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shan Dong Liao Cheng Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangxi Maternal and Child Health Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northwest Women's and Children's Hospital, Xi'an, Shaanxi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yin Chuan Maternity and Child Health Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nanjing Medical University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Eight hospitals in China will participate in the study, which aims to decrease the incidence&#xD;
      of severe hyperbilirubinemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Through a prospective cohort study of healthy term and near-term infants, the study tries to&#xD;
      truly reflect the epidemiology, intervention status, and outcomes of neonatal&#xD;
      hyperbilirubinemia and the cost. Hopefully, by improving the quality of management of&#xD;
      neonatal jaundice,we can explore and obtain a healthy term and near-term jaundice management&#xD;
      model suitable for China's national condition, which can eventually reduce the incidence rate&#xD;
      of neonatal severe hyperbilirubinemia and bilirubin encephalopathy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">October 15, 2021</completion_date>
  <primary_completion_date type="Actual">August 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of bilirubin encephalopathy</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of severe hyperbilirubinemia</measure>
    <time_frame>18 months</time_frame>
    <description>Severe hyperbilirubinemia:total serum bilirubin more than 20mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of lost to follow-up</measure>
    <time_frame>18 months</time_frame>
    <description>The rate of lost to follow-up for jaundice after discharge from well-baby nursery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of adverse neurological outcomes in patients with severe hyperbilirubinemia</measure>
    <time_frame>42 months</time_frame>
    <description>Patients with severe hyperbilirubinemia from 11 hospitals will be followed to investigate their neurological outcomes until 24 months after birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical costs in patients with severe hyperbilirubinemia</measure>
    <time_frame>18 months</time_frame>
    <description>To compare the medical costs in patients with severe hyperbilirubinemia from 3 phases of quality improvement.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20000</enrollment>
  <condition>Quality Improvement</condition>
  <condition>Hyperbilirubinemia, Neonatal</condition>
  <arm_group>
    <arm_group_label>Before-intervention phase</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All the healthy infants who were admitted from March 2018 to August 2018 to the Well Baby nurse of different hospitals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention phase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All the healthy infants who were admitted from September 2018 to February 2019 to the Well Baby nurse of different hospitals.During this phase,multiple intervention bundles of quality improvement will be implemented.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sustainability intervention phase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All the healthy infants who were admitted from March 2019 to August 2019 to the Well Baby nurse of different hospitals.In the Sustainability intervention phase,multiple intervention bundles of quality improvement will be continuous implemented.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Quality improvement of management of neonatal jaundice</intervention_name>
    <description>During the Intervention phase and Sustainability phase ,The hospitals will receive training of multiple evidence based quality improvement methods.</description>
    <arm_group_label>Intervention phase</arm_group_label>
    <arm_group_label>Sustainability intervention phase</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        term or near-term neonates with gestational age ≥35w and birth weight ≥2000g.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Infants admitted to a higher level of intervention before discharge.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shuping Han, PHD</last_name>
    <role>Study Director</role>
    <affiliation>Nanjing Maternity and Child Health Care Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhangbin Yu, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nanjing Maternity and Child Health Care Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhiyong Sun, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>JiLin Women and Children Health Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Haiyan Cai, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qinhuangdao Maternal and Child Health Care Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yonghui Yu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shandong Provincial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xin Yuan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shan Dong Qian Fo Shan Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jin Qian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shan Dong Liao Cheng Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jimei Wang, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Obstetrics &amp; Gynecology Hospital of Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wenyan Tang, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jiangxi Maternal and Child Health Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Qiufen Wei, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangxi Maternal and Child Health Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhankui Li, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwest Women's and Children's Hospital, Xi'an, Shaanxi</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jie Gu, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yin Chuan Maternity and Child Health Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nanjing Maternity and Child Health Care Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>October 29, 2021</last_update_submitted>
  <last_update_submitted_qc>October 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Zhangbin Yu</investigator_full_name>
    <investigator_title>Nan Jing Maternity and Child Health Care Hospital</investigator_title>
  </responsible_party>
  <keyword>Quality improvement</keyword>
  <keyword>Hyperbilirubinemia</keyword>
  <keyword>screening</keyword>
  <keyword>follow-up</keyword>
  <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>
  <!-- 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/NCT03824990
org study id: NMU-FY2018-72
nct id: NCT03824990
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Eight hospitals in China will participate in the study, which aims to decrease the incidence
      of severe hyperbilirubinemia.
Through a prospective cohort study of healthy term and near-term infants, the study tries to
      truly reflect the epidemiology, intervention status, and outcomes of neonatal
      hyperbilirubinemia and the cost. Hopefully, by improving the quality of management of
      neonatal jaundice,we can explore and obtain a healthy term and near-term jaundice management
      model suitable for China's national condition, which can eventually reduce the incidence rate
      of neonatal severe hyperbilirubinemia and bilirubin encephalopathy.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: The incidence of bilirubin encephalopathy
time frame: 18 months
measure: The incidence of severe hyperbilirubinemia
time frame: 18 months
description: Severe hyperbilirubinemia:total serum bilirubin more than 20mg/dL
measure: The rate of lost to follow-up
time frame: 18 months
description: The rate of lost to follow-up for jaundice after discharge from well-baby nursery
measure: The incidence of adverse neurological outcomes in patients with severe hyperbilirubinemia
time frame: 42 months
description: Patients with severe hyperbilirubinemia from 11 hospitals will be followed to investigate their neurological outcomes until 24 months after birth
measure: Medical costs in patients with severe hyperbilirubinemia
time frame: 18 months
description: To compare the medical costs in patients with severe hyperbilirubinemia from 3 phases of quality improvement.
arm group label: Before-intervention phase
arm group type: No Intervention
description: All the healthy infants who were admitted from March 2018 to August 2018 to the Well Baby nurse of different hospitals.
arm group label: Intervention phase
arm group type: Experimental
description: All the healthy infants who were admitted from September 2018 to February 2019 to the Well Baby nurse of different hospitals.During this phase,multiple intervention bundles of quality improvement will be implemented.
arm group label: Sustainability intervention phase
arm group type: Experimental
description: All the healthy infants who were admitted from March 2019 to August 2019 to the Well Baby nurse of different hospitals.In the Sustainability intervention phase,multiple intervention bundles of quality improvement will be continuous implemented.
intervention type: Behavioral
intervention name: Quality improvement of management of neonatal jaundice
description: During the Intervention phase and Sustainability phase ,The hospitals will receive training of multiple evidence based quality improvement methods.
arm group label: Intervention phase
arm group label: Sustainability intervention phase
criteria: 
gender: All
minimum age: 1 Day
maximum age: 28 Days
healthy volunteers: No
last name: Shuping Han, PHD
role: Study Director
affiliation: Nanjing Maternity and Child Health Care Hospital
last name: Zhangbin Yu, PHD
role: Principal Investigator
affiliation: Nanjing Maternity and Child Health Care Hospital
last name: Zhiyong Sun, PHD
role: Principal Investigator
affiliation: JiLin Women and Children Health Hospital
last name: Haiyan Cai, PHD
role: Principal Investigator
affiliation: Qinhuangdao Maternal and Child Health Care Hospital
last name: Yonghui Yu, MD
role: Principal Investigator
affiliation: Shandong Provincial Hospital
last name: Xin Yuan, MD
role: Principal Investigator
affiliation: Shan Dong Qian Fo Shan Hospital
last name: Jin Qian, MD
role: Principal Investigator
affiliation: Shan Dong Liao Cheng Hospital
last name: Jimei Wang, PHD
role: Principal Investigator
affiliation: Obstetrics & Gynecology Hospital of Fudan University
last name: Wenyan Tang, PHD
role: Principal Investigator
affiliation: Jiangxi Maternal and Child Health Hospital
last name: Qiufen Wei, PHD
role: Principal Investigator
affiliation: Guangxi Maternal and Child Health Hospital
last name: Zhankui Li, PHD
role: Principal Investigator
affiliation: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
last name: Jie Gu, PHD
role: Principal Investigator
affiliation: Yin Chuan Maternity and Child Health Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanjing Medical University
investigator full name: Zhangbin Yu
investigator title: Nan Jing Maternity and Child Health Care Hospital
mesh term: Hyperbilirubinemia, Neonatal
mesh term: Hyperbilirubinemia