<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/NCT01665261</url>
  </required_header>
  <id_info>
    <org_study_id>KY2011-366-1</org_study_id>
    <nct_id>NCT01665261</nct_id>
  </id_info>
  <brief_title>Newborn Screening for Congenital Heart Disease</brief_title>
  <acronym>NSCHD</acronym>
  <official_title>Accuracy Assessment of 7 Clinical Indicators in Newborn Screening for Congenital Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital of Fudan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the accuracy of 7 indicators in screening congenital&#xD;
      heart defects (CHD) in all newborns (symptomatic or asymptomatic) to determine whether these&#xD;
      indicators could be applied in the nationwide newborn CHD screening. The investigator's&#xD;
      hypothesis is that 7 indicators are effective in neonate CHD screening with the acceptable&#xD;
      accuracy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Congenital heart defects (CHD) are among the most common major congenital anomalies, and they&#xD;
      occur worldwide with an incidence of about 8-12/1,000 live births , Most of these defects are&#xD;
      mild or moderate. They either do not need treatment or treatment is needed only after&#xD;
      infancy. Other defects are severe and require early treatment in infancy, which are the&#xD;
      primary objectives of screening, because they are at risk of adverse or irreversible outcomes&#xD;
      as a consequence of congenital heart defects. However, about half the neonates in the nursery&#xD;
      have no distinctive clinical signs (symptoms, abnormal murmurs or cyanosis).So it's necessary&#xD;
      to develop a screening strategy for neonatologist and pediatrician, especially physicians in&#xD;
      community. Screening strategy in our study consists of 7 indicators: Family history of CHD,&#xD;
      tachypnea, heart murmurs(≥ 2 grade), cyanosis, other non-cardiac malformations,special face&#xD;
      feature（relating to chromosomal or non-chromosomal syndromes）, subnormal Pulse Oximetry&#xD;
      reading (Oxygen saturation of less than 95% in either limb or more than 3% difference）。The&#xD;
      newborn babies with any of these 7 indicators positive will be considered positive-screened&#xD;
      and echocardiography will performed.&#xD;
&#xD;
      The whole study (screening for CHDs with 7 indicators and performing the echocardiography for&#xD;
      diagnosis) will be conducted by one single investigator (Quming Zhao from Children's Hospital&#xD;
      of Fudan University). The new generation Pulse Oximetry has been proved to have low&#xD;
      intraobserver and interobserver variability, but the interobserver variability in clinical&#xD;
      evaluation (especially murmurs and cyanosis) remain unknown, the investigator will also&#xD;
      assess the interobserver variability by comparing Quming Zhao and other two pediatricians&#xD;
      (from the participating Hospital)(blind to each other).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy of the 7 indicators for detection of all CHDs and major CHDs</measure>
    <time_frame>The goldstandard for CHD diagnosis is the echocardiography performed within 1 hour from the screening completed.</time_frame>
    <description>Sensitivity, specificity, negative and positive predictive value, negative and positive likelihood ratio of 7 indicators for the detection of all CHDs and major CHDs as gold standard the echocardiography.</description>
  </primary_outcome>
  <enrollment type="Actual">6730</enrollment>
  <condition>Congenital Heart Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive neonates including pre-mature neonates and symptomatic neonates) will be&#xD;
        recruited prospectively from two collaboration hospitals of the ongoing projects- &quot;Key&#xD;
        Clinical Research Project Sponsored by Ministry of Health Screening, evaluation and&#xD;
        intervention of congenital heart disease in newborn infants(2010-239)&quot;&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all consecutive live newborn infants&#xD;
&#xD;
          -  between 6-72hours of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  declining the screening;&#xD;
&#xD;
          -  early discharge before the screening;&#xD;
&#xD;
          -  missing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Hours</minimum_age>
    <maximum_age>72 Hours</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huang G Ying, MD PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Children's Hospital of Fudan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Songjiang District Central Hospital</name>
      <address>
        <city>ShangHai</city>
        <state>Shanghai</state>
        <zip>201620</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Songjiang Maternal and Child Health Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>201620</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>de-Wahl Granelli A, Wennergren M, Sandberg K, Mellander M, Bejlum C, Inganas L, Eriksson M, Segerdahl N, Agren A, Ekman-Joelsson BM, Sunnegardh J, Verdicchio M, Ostman-Smith I. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009 Jan 8;338:a3037. doi: 10.1136/bmj.a3037.</citation>
    <PMID>19131383</PMID>
  </reference>
  <reference>
    <citation>Ewer AK, Furmston AT, Middleton LJ, Deeks JJ, Daniels JP, Pattison HM, Powell R, Roberts TE, Barton P, Auguste P, Bhoyar A, Thangaratinam S, Tonks AM, Satodia P, Deshpande S, Kumararatne B, Sivakumar S, Mupanemunda R, Khan KS. Pulse oximetry as a screening test for congenital heart defects in newborn infants: a test accuracy study with evaluation of acceptability and cost-effectiveness. Health Technol Assess. 2012;16(2):v-xiii, 1-184. doi: 10.3310/hta16020.</citation>
    <PMID>22284744</PMID>
  </reference>
  <reference>
    <citation>Mahle WT, Newburger JW, Matherne GP, Smith FC, Hoke TR, Koppel R, Gidding SS, Beekman RH 3rd, Grosse SD; American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, and Interdisciplinary Council on Quality of Care and Outcomes Research; American Academy of Pediatrics Section on Cardiology and Cardiac Surgery, and Committee on Fetus and Newborn. Role of pulse oximetry in examining newborns for congenital heart disease: a scientific statement from the American Heart Association and American Academy of Pediatrics. Circulation. 2009 Aug 4;120(5):447-58. doi: 10.1161/CIRCULATIONAHA.109.192576. Epub 2009 Jul 6.</citation>
    <PMID>19581492</PMID>
  </reference>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>March 10, 2015</last_update_submitted>
  <last_update_submitted_qc>March 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Guoying huang</investigator_full_name>
    <investigator_title>President of Children's Hospital of Fudan University</investigator_title>
  </responsible_party>
  <keyword>Congenital heart disease</keyword>
  <keyword>Newborn</keyword>
  <keyword>Pulse oximetry</keyword>
  <keyword>Screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</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/NCT01665261
org study id: KY2011-366-1
nct id: NCT01665261
lead sponsor: 
has dmc: Yes
The purpose of this study is to test the accuracy of 7 indicators in screening congenital
      heart defects (CHD) in all newborns (symptomatic or asymptomatic) to determine whether these
      indicators could be applied in the nationwide newborn CHD screening. The investigator's
      hypothesis is that 7 indicators are effective in neonate CHD screening with the acceptable
      accuracy.
Congenital heart defects (CHD) are among the most common major congenital anomalies, and they
      occur worldwide with an incidence of about 8-12/1,000 live births , Most of these defects are
      mild or moderate. They either do not need treatment or treatment is needed only after
      infancy. Other defects are severe and require early treatment in infancy, which are the
      primary objectives of screening, because they are at risk of adverse or irreversible outcomes
      as a consequence of congenital heart defects. However, about half the neonates in the nursery
      have no distinctive clinical signs (symptoms, abnormal murmurs or cyanosis).So it's necessary
      to develop a screening strategy for neonatologist and pediatrician, especially physicians in
      community. Screening strategy in our study consists of 7 indicators: Family history of CHD,
      tachypnea, heart murmurs(≥ 2 grade), cyanosis, other non-cardiac malformations,special face
      feature（relating to chromosomal or non-chromosomal syndromes）, subnormal Pulse Oximetry
      reading (Oxygen saturation of less than 95% in either limb or more than 3% difference）。The
      newborn babies with any of these 7 indicators positive will be considered positive-screened
      and echocardiography will performed.

      The whole study (screening for CHDs with 7 indicators and performing the echocardiography for
      diagnosis) will be conducted by one single investigator (Quming Zhao from Children's Hospital
      of Fudan University). The new generation Pulse Oximetry has been proved to have low
      intraobserver and interobserver variability, but the interobserver variability in clinical
      evaluation (especially murmurs and cyanosis) remain unknown, the investigator will also
      assess the interobserver variability by comparing Quming Zhao and other two pediatricians
      (from the participating Hospital)(blind to each other).
observational model: Cohort
time perspective: Prospective
measure: Diagnostic accuracy of the 7 indicators for detection of all CHDs and major CHDs
time frame: The goldstandard for CHD diagnosis is the echocardiography performed within 1 hour from the screening completed.
description: Sensitivity, specificity, negative and positive predictive value, negative and positive likelihood ratio of 7 indicators for the detection of all CHDs and major CHDs as gold standard the echocardiography.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Hours
maximum age: 72 Hours
healthy volunteers: No
last name: Huang G Ying, MD PHD
role: Study Chair
affiliation: Children's Hospital of Fudan University
facility: 
facility: 
country: China
citation: de-Wahl Granelli A, Wennergren M, Sandberg K, Mellander M, Bejlum C, Inganas L, Eriksson M, Segerdahl N, Agren A, Ekman-Joelsson BM, Sunnegardh J, Verdicchio M, Ostman-Smith I. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009 Jan 8;338:a3037. doi: 10.1136/bmj.a3037.
PMID: 19131383
citation: Ewer AK, Furmston AT, Middleton LJ, Deeks JJ, Daniels JP, Pattison HM, Powell R, Roberts TE, Barton P, Auguste P, Bhoyar A, Thangaratinam S, Tonks AM, Satodia P, Deshpande S, Kumararatne B, Sivakumar S, Mupanemunda R, Khan KS. Pulse oximetry as a screening test for congenital heart defects in newborn infants: a test accuracy study with evaluation of acceptability and cost-effectiveness. Health Technol Assess. 2012;16(2):v-xiii, 1-184. doi: 10.3310/hta16020.
PMID: 22284744
citation: Mahle WT, Newburger JW, Matherne GP, Smith FC, Hoke TR, Koppel R, Gidding SS, Beekman RH 3rd, Grosse SD; American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, and Interdisciplinary Council on Quality of Care and Outcomes Research; American Academy of Pediatrics Section on Cardiology and Cardiac Surgery, and Committee on Fetus and Newborn. Role of pulse oximetry in examining newborns for congenital heart disease: a scientific statement from the American Heart Association and American Academy of Pediatrics. Circulation. 2009 Aug 4;120(5):447-58. doi: 10.1161/CIRCULATIONAHA.109.192576. Epub 2009 Jul 6.
PMID: 19581492
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Guoying huang
investigator title: President of Children's Hospital of Fudan University
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital