<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/NCT03227302</url>
  </required_header>
  <id_info>
    <org_study_id>grades of doctor and neonaltal</org_study_id>
    <nct_id>NCT03227302</nct_id>
  </id_info>
  <brief_title>Associations of the Grades of Doctor and Neonatal Outcomes</brief_title>
  <official_title>Associations of the Grades of Doctor and Neonatal Outcomes: An Observational Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daping Hospital and the Research Institute of Surgery of the Third Military 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>
      In China, the standardized training system for residents was built last year, and the&#xD;
      associations of the grades of doctors and accoucheurs and neonatal outcomes remains unclear.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In China, the grades of doctors and accoucheurs are divided into four levels, and different&#xD;
      levels may induce differences of neonatal asphyxia and death. The standardized training&#xD;
      system for residents was built last year,the associations of the grades of doctors and&#xD;
      accoucheurs and neonatal asphyxia,neonatal death before and after the training systems need&#xD;
      to be assess.&#xD;
    </textblock>
  </detailed_description>
  <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">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2022</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>neonatal asphyxia</measure>
    <time_frame>within 28 days</time_frame>
    <description>neonatal asphyxia was defined according to manual of neonatal care</description>
  </primary_outcome>
  <primary_outcome>
    <measure>death</measure>
    <time_frame>within 28 days</time_frame>
    <description>neonatal death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bayley Scales of Infant Development</measure>
    <time_frame>at 2 months and 2 years old</time_frame>
    <description>to assess the development using Bayley Scales of Infant Development</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">20000</enrollment>
  <condition>Standardized Training System for Residents</condition>
  <condition>Neonatal Outcomes</condition>
  <arm_group>
    <arm_group_label>attending obstetrician</arm_group_label>
    <description>the low grade doctor who can do caesarean operation with no pregnant complications.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>associate chief obstetrician</arm_group_label>
    <description>The middle grade doctor who can do caesarean operation with no or mild or middle pregnant complications.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>chief obstetrician</arm_group_label>
    <description>the high doctor who can do all caesarean operation without limitations</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>attending obstetrician</intervention_name>
    <description>Attending obstetrician can do the caesarean operation without pregnant complications.</description>
    <arm_group_label>attending obstetrician</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>associate obstetrician</intervention_name>
    <description>Associate chief Obstetrician can do the caesarean operation without or mild or middle pregnant complications.</description>
    <arm_group_label>associate chief obstetrician</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>chief obstetrician</intervention_name>
    <description>Chief obstetrician can do all caesarean operation without limitations.</description>
    <arm_group_label>chief obstetrician</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All neonates with gestational age are from 26 weeks to 42 weeks&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age (GA) is from 26 to 42 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  major congenital malformations or complex congenital heart disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Minute</minimum_age>
    <maximum_age>100 Days</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Shi Yuan, PhD,MD</last_name>
    <role>Study Director</role>
    <affiliation>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ma Juan, MD</last_name>
    <phone>13883559467</phone>
    <email>476679422@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Pediatrics, Daping Hospital, Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400042</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Ma, physician</last_name>
      <phone>18680887330</phone>
      <email>zoe330@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>June 30, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>January 7, 2020</last_update_submitted>
  <last_update_submitted_qc>January 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</investigator_affiliation>
    <investigator_full_name>Ma Juan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03227302
org study id: grades of doctor and neonaltal
nct id: NCT03227302
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In China, the standardized training system for residents was built last year, and the
      associations of the grades of doctors and accoucheurs and neonatal outcomes remains unclear.
In China, the grades of doctors and accoucheurs are divided into four levels, and different
      levels may induce differences of neonatal asphyxia and death. The standardized training
      system for residents was built last year,the associations of the grades of doctors and
      accoucheurs and neonatal asphyxia,neonatal death before and after the training systems need
      to be assess.
observational model: Cohort
time perspective: Prospective
measure: neonatal asphyxia
time frame: within 28 days
description: neonatal asphyxia was defined according to manual of neonatal care
measure: death
time frame: within 28 days
description: neonatal death
measure: Bayley Scales of Infant Development
time frame: at 2 months and 2 years old
description: to assess the development using Bayley Scales of Infant Development
arm group label: attending obstetrician
description: the low grade doctor who can do caesarean operation with no pregnant complications.
arm group label: associate chief obstetrician
description: The middle grade doctor who can do caesarean operation with no or mild or middle pregnant complications.
arm group label: chief obstetrician
description: the high doctor who can do all caesarean operation without limitations
intervention type: Procedure
intervention name: attending obstetrician
description: Attending obstetrician can do the caesarean operation without pregnant complications.
arm group label: attending obstetrician
intervention type: Procedure
intervention name: associate obstetrician
description: Associate chief Obstetrician can do the caesarean operation without or mild or middle pregnant complications.
arm group label: associate chief obstetrician
intervention type: Procedure
intervention name: chief obstetrician
description: Chief obstetrician can do all caesarean operation without limitations.
arm group label: chief obstetrician
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Minute
maximum age: 100 Days
last name: Shi Yuan, PhD,MD
role: Study Director
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
last name: Ma Juan, MD
phone: 13883559467
email: 476679422@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
investigator full name: Ma Juan
investigator title: Principal Investigator