<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/NCT03235661</url>
  </required_header>
  <id_info>
    <org_study_id>twins with BiPAP</org_study_id>
    <nct_id>NCT03235661</nct_id>
  </id_info>
  <brief_title>Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins Infants</brief_title>
  <official_title>Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins:A Randomized Controlled Trials</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>
      The investigators compared advantages and disadvantages of two forms of noninvasive&#xD;
      respiratory support -bi-level positive airway pressure(BiPAP) or nasal continuous positive&#xD;
      airway pressure (nCPAP) -as a primary mode of ventilation in preterm twins infants with&#xD;
      respiratory distress syndrome&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Invasive ventilation is related to development of adverse pulmonary and nonpulmonary outcomes&#xD;
      in ventilated infants. Various modes of noninvasive respiratory support are being&#xD;
      increasingly used to minimize the incidence of bronchopulmonary dysplasia (BPD). The aim of&#xD;
      this trial to compare the effects of bi-level positive airway pressure(BiPAP) and nasal&#xD;
      continuous positive airway pressure (NCPAP) in preterm twins infants as the primary mode.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Anticipated">December 15, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>BiPAP and nCPAP are used as primary mode of ventilation in preterm twins infants with RDS</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intubation rate</measure>
    <time_frame>within 7 days</time_frame>
    <description>the baby was intubated</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>nCPAP</condition>
  <condition>BiPAP</condition>
  <condition>Respiratory Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>BiPAP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BiPAP as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nCPAP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BiPAP</intervention_name>
    <description>BiPAP is used as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome</description>
    <arm_group_label>BiPAP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>nCPAP</intervention_name>
    <description>nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome</description>
    <arm_group_label>nCPAP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Gestational age (GA) is from 26 to 37 weeks;&#xD;
&#xD;
          -  2. Diagnosis of respiratory distress syndrome. The diagnosis of respiratory distress&#xD;
             syndrome will be based on clinical manifestations (tachypnea, nasal flaring and or&#xD;
             grunting) and chest X-ray findings;&#xD;
&#xD;
          -  3. Respiratory distress syndrome Silverman score &gt;5;&#xD;
&#xD;
          -  4. Informed parental consent has been obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Severe respiratory distress syndrome requiring early intubation according to the&#xD;
             American Academy of Pediatrics guidelines for neonatal resuscitation;&#xD;
&#xD;
          -  2. Major congenital malformations or complex congenital heart disease;&#xD;
&#xD;
          -  3. Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary&#xD;
             hemorrhage;&#xD;
&#xD;
          -  4. Cardiopulmonary arrest needing prolonged resuscitation;&#xD;
&#xD;
          -  5. transferred out of the neonatal intensive care unit without treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Minutes</minimum_age>
    <maximum_age>6 Hours</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </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>
    <phone_ext>86</phone_ext>
    <email>476679422@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ma Juan, MD</last_name>
    <phone>1388.559467</phone>
    <phone_ext>86</phone_ext>
    <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>February 2021</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>February 14, 2021</last_update_submitted>
  <last_update_submitted_qc>February 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2021</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>Syndrome</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/NCT03235661
org study id: twins with BiPAP
nct id: NCT03235661
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators compared advantages and disadvantages of two forms of noninvasive
      respiratory support -bi-level positive airway pressure(BiPAP) or nasal continuous positive
      airway pressure (nCPAP) -as a primary mode of ventilation in preterm twins infants with
      respiratory distress syndrome
Invasive ventilation is related to development of adverse pulmonary and nonpulmonary outcomes
      in ventilated infants. Various modes of noninvasive respiratory support are being
      increasingly used to minimize the incidence of bronchopulmonary dysplasia (BPD). The aim of
      this trial to compare the effects of bi-level positive airway pressure(BiPAP) and nasal
      continuous positive airway pressure (NCPAP) in preterm twins infants as the primary mode.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: BiPAP and nCPAP are used as primary mode of ventilation in preterm twins infants with RDS
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: intubation rate
time frame: within 7 days
description: the baby was intubated
arm group label: BiPAP
arm group type: Experimental
description: BiPAP as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome
arm group label: nCPAP
arm group type: Active Comparator
description: nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome
intervention type: Device
intervention name: BiPAP
description: BiPAP is used as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome
arm group label: BiPAP
intervention type: Device
intervention name: nCPAP
description: nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome
arm group label: nCPAP
criteria: 
gender: All
minimum age: 5 Minutes
maximum age: 6 Hours
healthy volunteers: No
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
phone ext: 86
email: 476679422@qq.com
last name: Ma Juan, MD
phone: 1388.559467
phone ext: 86
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: Syndrome
sharing ipd: Undecided