<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/NCT03227289</url>
  </required_header>
  <id_info>
    <org_study_id>ARDS</org_study_id>
    <nct_id>NCT03227289</nct_id>
  </id_info>
  <brief_title>Acute Respiratory Distress Syndrome(ARDS) in Neonates</brief_title>
  <official_title>Pregnancy Risk Factors Promote Conversion From Neonatal Respiratory Distress Syndrome(NRDS) to Acute Respiratory Distress Syndrome(ARDS) : a Observational Cohort 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>
      Acute respiratory distress syndrome in neonates has been defined in 2015. Earlier&#xD;
      identification and successful intervention into the potential pregnancy associated risk&#xD;
      factors for the conversion from NRDS to ARDS is one of the most important components of ARDS&#xD;
      prevention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pregnancy risk factors (PRF), such as intrahepatic cholestasis during pregnancy(ICP),&#xD;
      hypertensive disorder complicating pregnancy(HDCP) and gestational diabetes mellitus(GDM),&#xD;
      are related to NRDS, ARDS and subsequent death. Meantime, it has also been proven that the&#xD;
      prevention of PRF reduces the risk of NRDS and ARDS. However, few study reported the&#xD;
      relations between PRF and the conversion from NRDS to ARDS, and it also remains unknown&#xD;
      whether treating PRF can reduce the progression from NRDS to ARDS.&#xD;
&#xD;
      We have found that PRF were related to the increase and deterioration of NRDS in a Chinese&#xD;
      cohort. The aims of the present study were: 1). to report the effects of PRF on the&#xD;
      conversion from NRDS to ARDS. 2). to clarify whether PRF treatment could prevention from&#xD;
      conversion from NRDS to ARDS in a Chinese population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2015</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</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>the effects of Pregnancy risk factors (PRF) on the conversion from NRDS to ARDS</measure>
    <time_frame>within 28 days</time_frame>
    <description>the effects of Pregnancy risk factors (PRF) on the conversion from NRDS to ARDS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>clarify whether PRF treatment could prevention from conversion from NRDS to ARDS</measure>
    <time_frame>within 28 days</time_frame>
    <description>clarify whether PRF treatment could prevention from conversion from NRDS to ARDS</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>ARDS</condition>
  <condition>NRDS</condition>
  <arm_group>
    <arm_group_label>Stayed in NRDS</arm_group_label>
    <description>The neonates with NRDS are stayed in NRDS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Converted to ARDS</arm_group_label>
    <description>The neonates with NRDS are converted to ARDS</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stayed in NRDS</intervention_name>
    <description>The neonates with NRDS are stayed in NRDS.</description>
    <arm_group_label>Stayed in NRDS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Converted to ARDS</intervention_name>
    <description>The neonates with NRDS are converted to ARDS.</description>
    <arm_group_label>Converted to ARDS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The gestational age was less than 37 weeks;&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The gestational age was less than 37 weeks;&#xD;
&#xD;
          2. These neonates were diagnosed with NRDS; The diagnosis of NRDS was based on clinical&#xD;
             manifestations and chest X-ray findings. The clinical signs and symptoms of NRDS were&#xD;
             respiratory distress, tachypnea, nasal flaring, groan, and cyanosis after birth. The&#xD;
             typical X-ray picture of RDS showed a grain shadow, air bronchogram or white lung.&#xD;
&#xD;
          3. informed parental consent has been obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. parents' decision not to participate;&#xD;
&#xD;
          2. major congenital anomalies;&#xD;
&#xD;
          3. died or left the neonatal intensive care unit(NICU) within 24 hour.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Minutes</minimum_age>
    <maximum_age>28 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>13508300283</phone>
    <email>476679422@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ma Juan, MD</last_name>
    <phone>1388.559467</phone>
    <email>476679422@qq.com</email>
  </overall_contact_backup>
  <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>October 2022</verification_date>
  <study_first_submitted>July 12, 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>October 23, 2022</last_update_submitted>
  <last_update_submitted_qc>October 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03227289
org study id: ARDS
nct id: NCT03227289
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Acute respiratory distress syndrome in neonates has been defined in 2015. Earlier
      identification and successful intervention into the potential pregnancy associated risk
      factors for the conversion from NRDS to ARDS is one of the most important components of ARDS
      prevention.
Pregnancy risk factors (PRF), such as intrahepatic cholestasis during pregnancy(ICP),
      hypertensive disorder complicating pregnancy(HDCP) and gestational diabetes mellitus(GDM),
      are related to NRDS, ARDS and subsequent death. Meantime, it has also been proven that the
      prevention of PRF reduces the risk of NRDS and ARDS. However, few study reported the
      relations between PRF and the conversion from NRDS to ARDS, and it also remains unknown
      whether treating PRF can reduce the progression from NRDS to ARDS.

      We have found that PRF were related to the increase and deterioration of NRDS in a Chinese
      cohort. The aims of the present study were: 1). to report the effects of PRF on the
      conversion from NRDS to ARDS. 2). to clarify whether PRF treatment could prevention from
      conversion from NRDS to ARDS in a Chinese population.
observational model: Cohort
time perspective: Prospective
measure: the effects of Pregnancy risk factors (PRF) on the conversion from NRDS to ARDS
time frame: within 28 days
description: the effects of Pregnancy risk factors (PRF) on the conversion from NRDS to ARDS
measure: clarify whether PRF treatment could prevention from conversion from NRDS to ARDS
time frame: within 28 days
description: clarify whether PRF treatment could prevention from conversion from NRDS to ARDS
arm group label: Stayed in NRDS
description: The neonates with NRDS are stayed in NRDS
arm group label: Converted to ARDS
description: The neonates with NRDS are converted to ARDS
intervention type: Other
intervention name: Stayed in NRDS
description: The neonates with NRDS are stayed in NRDS.
arm group label: Stayed in NRDS
intervention type: Other
intervention name: Converted to ARDS
description: The neonates with NRDS are converted to ARDS.
arm group label: Converted to ARDS
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 5 Minutes
maximum age: 28 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: 13508300283
email: 476679422@qq.com
last name: Ma Juan, MD
phone: 1388.559467
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
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
sharing ipd: Undecided