<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/NCT01685697</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00033526</org_study_id>
    <nct_id>NCT01685697</nct_id>
  </id_info>
  <brief_title>Mask Ventilation With Different Face Masks During Neonatal Resuscitation</brief_title>
  <official_title>Comparison of Two Round Face Masks During Neonatal Resuscitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Most premature babies have difficulty breathing at birth and need help (what we call&#xD;
      resuscitation). The treatment for this is to gently inflate their lungs with a resuscitation&#xD;
      device and a facemask. The device commonly used is a T-Piece infant resuscitator (which we&#xD;
      call the T-Piece) and is used at The Royal Alexandra Hospital and all round the world.&#xD;
&#xD;
      To gentle inflate an infants lung the clinical team put a face mask around your baby's mouth&#xD;
      and nose. The clinical team tries to achieve a good seal between the face and the mask. A&#xD;
      problem of mask ventilation is that air can escape between the mask and the face (what we&#xD;
      call mask leak). Currently, two different types of facemasks (&quot;Laerdal mask&quot; or &quot;Fisher &amp;&#xD;
      Paykel mask&quot;) are routinely used in the delivery room at The Royal Alexandra Hospital.&#xD;
&#xD;
      The purpose of this study is to find out if one facemask is leaking less between the face and&#xD;
      the mask.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will use a Laerdal round mask (Laerdal, Stavanger, Norway) compared to a Fisher &amp; Paykel&#xD;
      (FP) (Fisher &amp; Paykel Healthcare, Auckland, New Zealand) 'round' neonatal resuscitation mask.&#xD;
      The two point top hold for Laerdal 'round' mask and the rim hold for the Fisher &amp; Paykel&#xD;
      mask.&#xD;
&#xD;
      A Respiratory Function Monitor will be placed between the face mask and the ventilation&#xD;
      device. It uses a small (dead space 1 mL) flow sensor to measure gas flow in and out of a&#xD;
      face mask. This signal is automatically integrated to provide inspired and expired tidal&#xD;
      volume. The difference equals the leak from the face mask. It also calculates respiratory&#xD;
      rate and minute ventilation, measures spontaneous inspirations and ventilation pressures. The&#xD;
      signals of airway flow, tidal volumes, airway pressure, inspired oxygen concentration,&#xD;
      temperature, blood pressure, oxygen saturation, heart rate will be digitised and recorded at&#xD;
      200Hz using the Spectra physiological recording program (a customised neonatal respiratory&#xD;
      physiology program).&#xD;
&#xD;
      We will compare the % of mask leak within the two face masks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in Percentage of Leak</measure>
    <time_frame>during mask ventilation in the first 5 minutes after birth</time_frame>
    <description>Primary outcome: Difference in percentage of Leak</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Respiration; Insufficient or Poor, Newborn</condition>
  <arm_group>
    <arm_group_label>Laerdal Mask</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mask ventilation with a Laerdal face mask</description>
  </arm_group>
  <arm_group>
    <arm_group_label>F&amp;P Mask</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mask ventilation with a F&amp;P face mask</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mask ventilation with a Laerdal face mask</intervention_name>
    <description>Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group.</description>
    <arm_group_label>Laerdal Mask</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mask ventilation with a F&amp;P face mask</intervention_name>
    <description>Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group.</description>
    <arm_group_label>F&amp;P Mask</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Preterm infants &lt;32 weeks gestation born at The Royal Alexandra Hospital who require&#xD;
             resuscitation in the delivery room will be recorded.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants will be excluded from final analysis if they have a congenital abnormality or&#xD;
             condition that might have an adverse effect on breathing or ventilation, including:&#xD;
             Congenital Diaphragmatic Hernia. Infants will also be excluded if their parents refuse&#xD;
             to give consent to this study.&#xD;
&#xD;
        Participants will be included in the first minutes after birth if they require mask&#xD;
        ventilation for poor respiratory effort. Data will be collected from the Hospital chart&#xD;
        until discharge at around 40 weeks gestation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>30 Minutes</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Georg Schmolzer, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Alexandra Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5H 3V9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Wood FE, Morley CJ, Dawson JA, Kamlin CO, Owen LS, Donath S, Davis PG. Improved techniques reduce face mask leak during simulated neonatal resuscitation: study 2. Arch Dis Child Fetal Neonatal Ed. 2008 May;93(3):F230-4. doi: 10.1136/adc.2007.117788. Epub 2007 Nov 26.</citation>
    <PMID>18039750</PMID>
  </reference>
  <reference>
    <citation>Chua C, Schmolzer GM, Davis PG. Airway manoeuvres to achieve upper airway patency during mask ventilation in newborn infants - An historical perspective. Resuscitation. 2012 Apr;83(4):411-6. doi: 10.1016/j.resuscitation.2011.11.007. Epub 2011 Nov 18.</citation>
    <PMID>22101203</PMID>
  </reference>
  <reference>
    <citation>Schmolzer GM, Morley CJ, Wong C, Dawson JA, Kamlin CO, Donath SM, Hooper SB, Davis PG. Respiratory function monitor guidance of mask ventilation in the delivery room: a feasibility study. J Pediatr. 2012 Mar;160(3):377-381.e2. doi: 10.1016/j.jpeds.2011.09.017. Epub 2011 Nov 5.</citation>
    <PMID>22056350</PMID>
  </reference>
  <reference>
    <citation>Schmolzer GM, Kamlin OC, O'Donnell CP, Dawson JA, Morley CJ, Davis PG. Assessment of tidal volume and gas leak during mask ventilation of preterm infants in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2010 Nov;95(6):F393-7. doi: 10.1136/adc.2009.174003. Epub 2010 Jun 14.</citation>
    <PMID>20547584</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <results_first_submitted>January 6, 2017</results_first_submitted>
  <results_first_submitted_qc>November 5, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 7, 2018</results_first_posted>
  <last_update_submitted>November 5, 2018</last_update_submitted>
  <last_update_submitted_qc>November 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <recruitment_details>March 2013 to September 2013</recruitment_details>
      <pre_assignment_details>The study used deferred consent approach. In this approach patient are randomized and asked to participant afterwards because of minimal risk to participation this study. Therefore there are a larger number of participant at the start date of the study and if they decline to participate a lower enrolled number.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Laerdal Mask</title>
          <description>Mask ventilation with a Laerdal face mask&#xD;
Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group.&#xD;
Mask ventilation with a F&amp;P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group.</description>
        </group>
        <group group_id="P2">
          <title>F&amp;P Mask</title>
          <description>Mask ventilation with a F&amp;P face mask&#xD;
Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group.&#xD;
Mask ventilation with a F&amp;P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Laerdal Mask</title>
          <description>Mask ventilation with a Laerdal face mask&#xD;
Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group.&#xD;
Mask ventilation with a F&amp;P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group.</description>
        </group>
        <group group_id="B2">
          <title>F&amp;P Mask</title>
          <description>Mask ventilation with a F&amp;P face mask&#xD;
Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group.&#xD;
Mask ventilation with a F&amp;P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="28"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="56"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Gestational age in weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28" spread="2"/>
                    <measurement group_id="B2" value="28" spread="3"/>
                    <measurement group_id="B3" value="28" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Difference in Percentage of Leak</title>
        <description>Primary outcome: Difference in percentage of Leak</description>
        <time_frame>during mask ventilation in the first 5 minutes after birth</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Laerdal Mask</title>
            <description>Potentially eligible infants were randomized immediately prior to delivery and then received PPV as clinically necessary with either the F&amp;P ∅35mm or ∅42mm F&amp;P mask.</description>
          </group>
          <group group_id="O2">
            <title>F&amp;P Mask</title>
            <description>Potentially eligible infants were randomized immediately prior to delivery and then received PPV as clinically necessary with either the F&amp;P ∅35mm or ∅42mm F&amp;P mask.</description>
          </group>
        </group_list>
        <measure>
          <title>Difference in Percentage of Leak</title>
          <description>Primary outcome: Difference in percentage of Leak</description>
          <units>% (percentage of mass leak)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35" lower_limit="24" upper_limit="46"/>
                    <measurement group_id="O2" value="30" lower_limit="25" upper_limit="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Laerdal Mask</title>
          <description>Mask ventilation with a Laerdal face mask&#xD;
Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group.&#xD;
Mask ventilation with a F&amp;P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group.</description>
        </group>
        <group group_id="E2">
          <title>F&amp;P Mask</title>
          <description>Mask ventilation with a F&amp;P face mask&#xD;
Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group.&#xD;
Mask ventilation with a F&amp;P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Death during Admissions</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Georg Schmolzer</name_or_title>
      <organization>Univeristy of Alberta</organization>
      <phone>7807354660</phone>
      <email>georg.schmoelzer@me.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01685697
org study id: Pro00033526
nct id: NCT01685697
lead sponsor: 
has dmc: Yes
Most premature babies have difficulty breathing at birth and need help (what we call
      resuscitation). The treatment for this is to gently inflate their lungs with a resuscitation
      device and a facemask. The device commonly used is a T-Piece infant resuscitator (which we
      call the T-Piece) and is used at The Royal Alexandra Hospital and all round the world.

      To gentle inflate an infants lung the clinical team put a face mask around your baby's mouth
      and nose. The clinical team tries to achieve a good seal between the face and the mask. A
      problem of mask ventilation is that air can escape between the mask and the face (what we
      call mask leak). Currently, two different types of facemasks ("Laerdal mask" or "Fisher &
      Paykel mask") are routinely used in the delivery room at The Royal Alexandra Hospital.

      The purpose of this study is to find out if one facemask is leaking less between the face and
      the mask.
We will use a Laerdal round mask (Laerdal, Stavanger, Norway) compared to a Fisher & Paykel
      (FP) (Fisher & Paykel Healthcare, Auckland, New Zealand) 'round' neonatal resuscitation mask.
      The two point top hold for Laerdal 'round' mask and the rim hold for the Fisher & Paykel
      mask.

      A Respiratory Function Monitor will be placed between the face mask and the ventilation
      device. It uses a small (dead space 1 mL) flow sensor to measure gas flow in and out of a
      face mask. This signal is automatically integrated to provide inspired and expired tidal
      volume. The difference equals the leak from the face mask. It also calculates respiratory
      rate and minute ventilation, measures spontaneous inspirations and ventilation pressures. The
      signals of airway flow, tidal volumes, airway pressure, inspired oxygen concentration,
      temperature, blood pressure, oxygen saturation, heart rate will be digitised and recorded at
      200Hz using the Spectra physiological recording program (a customised neonatal respiratory
      physiology program).

      We will compare the % of mask leak within the two face masks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Difference in Percentage of Leak
time frame: during mask ventilation in the first 5 minutes after birth
description: Primary outcome: Difference in percentage of Leak
arm group label: Laerdal Mask
arm group type: Active Comparator
description: Mask ventilation with a Laerdal face mask
arm group label: F&P Mask
arm group type: Experimental
description: Mask ventilation with a F&P face mask
intervention type: Procedure
intervention name: Mask ventilation with a Laerdal face mask
description: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group.
arm group label: Laerdal Mask
intervention type: Procedure
intervention name: Mask ventilation with a F&P face mask
description: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group.
arm group label: F&P Mask
criteria: 
gender: All
minimum age: N/A
maximum age: 30 Minutes
healthy volunteers: No
last name: Georg Schmolzer, MD,PhD
role: Principal Investigator
affiliation: University of Alberta
facility: 
country: Canada
citation: Wood FE, Morley CJ, Dawson JA, Kamlin CO, Owen LS, Donath S, Davis PG. Improved techniques reduce face mask leak during simulated neonatal resuscitation: study 2. Arch Dis Child Fetal Neonatal Ed. 2008 May;93(3):F230-4. doi: 10.1136/adc.2007.117788. Epub 2007 Nov 26.
PMID: 18039750
citation: Chua C, Schmolzer GM, Davis PG. Airway manoeuvres to achieve upper airway patency during mask ventilation in newborn infants - An historical perspective. Resuscitation. 2012 Apr;83(4):411-6. doi: 10.1016/j.resuscitation.2011.11.007. Epub 2011 Nov 18.
PMID: 22101203
citation: Schmolzer GM, Morley CJ, Wong C, Dawson JA, Kamlin CO, Donath SM, Hooper SB, Davis PG. Respiratory function monitor guidance of mask ventilation in the delivery room: a feasibility study. J Pediatr. 2012 Mar;160(3):377-381.e2. doi: 10.1016/j.jpeds.2011.09.017. Epub 2011 Nov 5.
PMID: 22056350
citation: Schmolzer GM, Kamlin OC, O'Donnell CP, Dawson JA, Morley CJ, Davis PG. Assessment of tidal volume and gas leak during mask ventilation of preterm infants in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2010 Nov;95(6):F393-7. doi: 10.1136/adc.2009.174003. Epub 2010 Jun 14.
PMID: 20547584
responsible party type: Sponsor
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