<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/NCT01664832</url>
  </required_header>
  <id_info>
    <org_study_id>ULMN_SIMV</org_study_id>
    <nct_id>NCT01664832</nct_id>
  </id_info>
  <brief_title>Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?</brief_title>
  <acronym>N_SIMV</acronym>
  <official_title>Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. Helmut Hummler</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Ulm</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is the examination of the hypothesis that synchronized nasal IMV as&#xD;
      compared to non-synchronized nasal IMV will decrease breathing effort in preterm infants&#xD;
      immediately after extubation when recovering from Respiratory distress syndrome (RDS).&#xD;
&#xD;
      Another objective is to examine the effects for synchronized non-invasive mechanical&#xD;
      ventilation on gas exchange and cerebral oxygen saturation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study the investigators plan to test the hypothesis that synchronized nasal IMV&#xD;
      (S-NIMV) as compared to non-synchronized nasal IMV (NIMV) will decrease breathing effort in&#xD;
      preterm infants immediately after extubation when recovery from RDS, as measured by phasic&#xD;
      esophageal pressure deflection.&#xD;
&#xD;
      Furthermore, the investigators plan to evaluate the effects of synchronized NIMV on gas&#xD;
      exchange and brain oxygenation, and to evaluate the reliability of a newly developed&#xD;
      abdominal pressure sensor device for the S-NIMV mode in a newly designed commercially&#xD;
      available ventilator device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <primary_completion_date type="Anticipated">September 2013</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>Crossover Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>phasic esophageal pressure deflection</measure>
    <time_frame>4 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cerebral oxygen saturation</measure>
    <time_frame>4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial oxygen saturation</measure>
    <time_frame>4 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Respiratory Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>S-nIMV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>nIMV synchronized using abdominal pressure capsule sensor device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nIMV</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>non-synchronized nasal intermittent mandatory ventilation group</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>S-nIMV</intervention_name>
    <description>Synchronization of nasal breaths to infant's own respiratory effort</description>
    <arm_group_label>S-nIMV</arm_group_label>
    <arm_group_label>nIMV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Preterm infants recovering from respiratory failure with the following criteria were&#xD;
        eligible for this study.&#xD;
&#xD;
          -  Gestational age &lt;32 wks, those who are on invasive mechanical ventilation, recovering&#xD;
             from RDS, and ready for extubation as judged by the clinical team.&#xD;
&#xD;
          -  Informed consent available.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Infants with major congenital anomalies involving the CNS, lung (i.e. lung hypoplasia,&#xD;
        active air leaks) or the heart (ASD, VSD allowed), or known neuromuscular disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hummler Helmut, Prof. Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ulm</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Helmut Hummle, Prof. Dr.</last_name>
    <phone>0731-500-57168</phone>
    <email>helmut.hummler@uniklinik-ulm.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Li Huang, Master</last_name>
    <phone>015776891592</phone>
    <email>hhuangli@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Children's Hospital University of Ulm</name>
      <address>
        <city>Ulm</city>
        <state>Baden-Wüttemberg</state>
        <zip>89075</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Helmut Hummler, Prof. Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>June 26, 2013</last_update_submitted>
  <last_update_submitted_qc>June 26, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 27, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Ulm</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Helmut Hummler</investigator_full_name>
    <investigator_title>Prof. Dr. Helmut Hummler</investigator_title>
  </responsible_party>
  <keyword>Premature Infants</keyword>
  <keyword>snychronized ventilation</keyword>
  <keyword>non-invasive ventilation</keyword>
  <keyword>RDS</keyword>
  <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>
  </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/NCT01664832
org study id: ULMN_SIMV
nct id: NCT01664832
lead sponsor: 
has dmc: No
The purpose of this study is the examination of the hypothesis that synchronized nasal IMV as
      compared to non-synchronized nasal IMV will decrease breathing effort in preterm infants
      immediately after extubation when recovering from Respiratory distress syndrome (RDS).

      Another objective is to examine the effects for synchronized non-invasive mechanical
      ventilation on gas exchange and cerebral oxygen saturation.
In this study the investigators plan to test the hypothesis that synchronized nasal IMV
      (S-NIMV) as compared to non-synchronized nasal IMV (NIMV) will decrease breathing effort in
      preterm infants immediately after extubation when recovery from RDS, as measured by phasic
      esophageal pressure deflection.

      Furthermore, the investigators plan to evaluate the effects of synchronized NIMV on gas
      exchange and brain oxygenation, and to evaluate the reliability of a newly developed
      abdominal pressure sensor device for the S-NIMV mode in a newly designed commercially
      available ventilator device.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: phasic esophageal pressure deflection
time frame: 4 hours
measure: Cerebral oxygen saturation
time frame: 4 hours
measure: Arterial oxygen saturation
time frame: 4 hours
arm group label: S-nIMV
arm group type: Experimental
description: nIMV synchronized using abdominal pressure capsule sensor device
arm group label: nIMV
arm group type: Placebo Comparator
description: non-synchronized nasal intermittent mandatory ventilation group
intervention type: Device
intervention name: S-nIMV
description: Synchronization of nasal breaths to infant's own respiratory effort
arm group label: S-nIMV
arm group label: nIMV
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Hummler Helmut, Prof. Dr
role: Principal Investigator
affiliation: University of Ulm
last name: Helmut Hummle, Prof. Dr.
phone: 0731-500-57168
email: helmut.hummler@uniklinik-ulm.de
last name: Li Huang, Master
phone: 015776891592
email: hhuangli@hotmail.com
facility: 
status: Recruiting
investigator: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: University of Ulm
investigator full name: Prof. Dr. Helmut Hummler
investigator title: Prof. Dr. Helmut Hummler
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn