xml: <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/NCT05963516</url>
    </required_header>
    <id_info>
      <org_study_id>23-0267</org_study_id>
      <secondary_id>R33HD103058</secondary_id>
      <secondary_id>IGHID 12309</secondary_id>
      <nct_id>NCT05963516</nct_id>
    </id_info>
    <brief_title>Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study)</brief_title>
    <official_title>Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of North Carolina, Chapel Hill</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>Doris Duke Charitable Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Laerdal Global Health</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Kinshasa School of Public Health</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of North Carolina, Chapel Hill</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Purpose: To evaluate the effectiveness of newborn resuscitation feedback supported by a&#xD;
        mobile health application called LIVEBORN; secondarily, to evaluate the relative&#xD;
        effectiveness of real-time guidance vs debriefing.&#xD;
  &#xD;
        Participants: Newborns and Nurse midwives&#xD;
  &#xD;
        Procedures (methods): This is a pre-post interventional trial to evaluate the effectiveness&#xD;
        of LIVEBORN feedback. The investigators will use a randomized design to test the relative&#xD;
        effectiveness of two modes of feedback: real-time guidance versus debriefing. Given the&#xD;
        potential for feedback interventions to have spillover effects, the investigators will&#xD;
        randomize by cluster (i.e., facility) rather than by individual. The study will begin with an&#xD;
        approximately two-month pilot phase to establish systems for implementation of recommended&#xD;
        training and simulation practice and consistent use of LIVEBORN for observations. After these&#xD;
        systems have been successfully established, the investigators will initiate the pre-post&#xD;
        trial. The control phase will last six months followed by implementation of LIVEBORN feedback&#xD;
        in an intervention phase lasting 12 months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study Sites:&#xD;
  &#xD;
        the investigators will conduct this pre-post interventional trial in six health facilities in&#xD;
        Kinshasa, Democratic Republic of the Congo (DRC).&#xD;
  &#xD;
        Pilot Phase:&#xD;
  &#xD;
        The purpose of the pilot phase is to establish systems to ensure 1) implementation of&#xD;
        recommended training and simulation practice and 2) consistent use of LIVEBORN for&#xD;
        observations. The pilot phase will last approximately two months. Any facilities deemed&#xD;
        facile with LIVEBORN will be exempted from the pilot phase.&#xD;
  &#xD;
        Establishment of a System for Implementation of Recommended Training and Simulation Practice:&#xD;
        During the pilot phase, the investigators will work with each facility to ensure a system for&#xD;
        implementation of recommended resuscitation training and low-dose high-frequency (LDHF)&#xD;
        practice of bag-mask ventilation (BMV).&#xD;
  &#xD;
        Basic Resuscitation Training: The investigators will train all nurse midwives in basic&#xD;
        resuscitation using Helping Babies Breathe (HBB) 2.0 materials adapted to include the use of&#xD;
        NeoBeat, a battery-operated heart rate (HR) meter. In addition to reviewing the&#xD;
        evidence-based HBB resuscitation algorithm, research staff will orient nurse midwives to use&#xD;
        of NeoBeat. The training will also include how to use HR to accurately distinguish liveborn&#xD;
        from stillborn infants. The investigators will recommend that nurse midwives use NeoBeat for&#xD;
        high-risk pregnancies and newborns not crying by 30 seconds.&#xD;
  &#xD;
        Establishment of a System for Consistent Use of LIVEBORN for Observations: During the pilot&#xD;
        phase, the investigators will work with each facility to ensure a system for consistent use&#xD;
        of LIVEBORN for observations. This system will include placement of NeoBeat on newborns&#xD;
        requiring resuscitation.&#xD;
  &#xD;
        The investigators will use an established participatory research methodology called trials of&#xD;
        improved practices (TIPs) which the investigators successfully used in the R21 phase of this&#xD;
        work to design a strategy for consistent use of LIVEBORN for observations. At each facility,&#xD;
        the investigators will conduct a strategy development session with facility leadership such&#xD;
        as the head nurse midwife to develop an initial strategy for implementation of LIVEBORN. Each&#xD;
        health facility will implement the locally-developed initial strategy in a small-scale test&#xD;
        for approximately three weeks. Throughout the small-scale test, the investigators will&#xD;
        rapidly analyze data and identify barriers to implementation of the strategy as well as&#xD;
        potential solutions. The investigators will refine the strategy in additional cycles of TIPs&#xD;
        (strategy development, small-scale testing, rapid analysis) until the investigators have&#xD;
        identified a feasible strategy to move into the control phase.&#xD;
  &#xD;
        Control Phase:&#xD;
  &#xD;
        The purpose of the control phase is to gather detailed, prospective data on resuscitation&#xD;
        care and newborn outcomes while implementing recommended practice. During a six-month control&#xD;
        phase, midwives will implement HBB in their clinical practice with LDHF simulation practice&#xD;
        of BMV. LDHF practice will occur at regular intervals per the system set up during the pilot&#xD;
        phase. Nurse midwives will place NeoBeat on newborns that they anticipate resuscitating.&#xD;
  &#xD;
        Data Collection: Research staff will conduct medical record abstraction to document clinical&#xD;
        data for each eligible newborn including such elements as maternal parity and age, birth date&#xD;
        and time, infant gestational age, birth weight, mode of delivery, stillborn or liveborn,&#xD;
        alive or dead at discharge (including date of death). As in the pilot phase, trained&#xD;
        observers (research staff, midwives, and other designated observers per the strategy&#xD;
        developed in the pilot phase) will conduct observations of resuscitations for a convenience&#xD;
        sample of births using the LIVEBORN app. If NeoBeat is placed on the newborn, the&#xD;
        investigators will collect ECG data.&#xD;
  &#xD;
        Preparatory Activities for the Intervention Phase: While in the control phase, the&#xD;
        investigators will randomize facilities to either real-time guidance or debriefing with&#xD;
        LIVEBORN in preparation for the intervention phase. Prior to implementation of the&#xD;
        intervention and towards the end of the control phase, research staff will prepare nurse&#xD;
        midwives to implement LIVEBORN feedback per their cluster randomized assignment using&#xD;
        simulation.&#xD;
  &#xD;
        Intervention Phase:&#xD;
  &#xD;
        The purpose of the intervention phase is to gather prospective data on resuscitation care and&#xD;
        newborn outcomes during implementation of LIVEBORN feedback. During this 12-month phase,&#xD;
        nurse midwives will implement LIVEBORN feedback per their cluster-randomized assignment to&#xD;
        either real-time guidance or debriefing. Additionally, nurse midwives will continue all study&#xD;
        procedures from the control phase, including implementation of HBB with LDHF practice, use of&#xD;
        NeoBeat on newborns requiring resuscitation, and observation of births using LIVEBORN.&#xD;
  &#xD;
        Implementation of LIVEBORN Feedback: At facilities randomized to real-time guidance, midwives&#xD;
        will be supported by audio-visual feedback from LIVEBORN during the convenience sample of&#xD;
        resuscitations observed with LIVEBORN. At facilities randomized to debriefing, midwives will&#xD;
        debrief with LIVEBORN for at least 50% of the convenience sample of resuscitations observed&#xD;
        with LIVEBORN that involved a newborn not crying by 60 seconds after birth and/or the receipt&#xD;
        of BMV.&#xD;
  &#xD;
        Data Collection: As in the control phase, research staff will conduct medical record&#xD;
        abstraction to document clinical data for each enrolled. As in the pilot and control phases,&#xD;
        trained observers (research staff, midwives, and other designated observers per the strategy&#xD;
        developed in the pilot phase) will conduct observations of resuscitations for a convenience&#xD;
        sample of births using the LIVEBORN app. If NeoBeat is placed on the newborn, the&#xD;
        investigators will collect ECG data. At the end of the intervention, five midwives &amp; the head&#xD;
        nurse midwife from each facility will complete surveys consisting of 4-item quantitative&#xD;
        scales to evaluate feasibility and acceptability using the Feasibility of Intervention&#xD;
        Measure (FIM) and Acceptability of Intervention Measure (AIM).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 23, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2025</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mean Duration of Suctioning Among Newborns Not Crying By 30 Seconds</measure>
      <time_frame>First hour after birth</time_frame>
      <description>The investigators will measure duration of suctioning as a continuous variable among liveborn neonates who are not crying by 30 seconds. This variable will be collected via direct observation using the Liveborn application.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Median Duration of Suctioning Among Newborns Not Crying By 30 Seconds</measure>
      <time_frame>First hour after birth</time_frame>
      <description>The investigators will measure duration of suctioning as a continuous variable among liveborn neonates who are not crying by 30 seconds. This variable will be collected via direct observation using the Liveborn application.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Suctioned For &lt;30 Seconds Among Newborns Not Crying By 30 Seconds</measure>
      <time_frame>First hour after birth</time_frame>
      <description>The investigators will report the proportion of livebirths not crying by 30 seconds who are suctioned for less than 30 seconds. This variable will be collected via direct observation using the Liveborn application.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Time to Bag Mask Ventilation</measure>
      <time_frame>First hour after birth</time_frame>
      <description>The investigators will measure time to BMV as a continuous variable, defining time to BMV as the number of seconds between birth and the start of BMV. They will report time to BMV among all livebirths not crying by 30 seconds who receive BMV. This variable will be collected via direct observation using the Liveborn application.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Median Time to Bag Mask Ventilation</measure>
      <time_frame>First hour after birth</time_frame>
      <description>The investigators will measure time to BMV as a continuous variable, defining time to BMV as the number of seconds between birth and the start of BMV. They will report time to BMV among all livebirths not crying by 30 seconds who receive BMV. This variable will be collected via direct observation using the Liveborn application.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of Newborns Who Receive BMV within the Golden Minute Among All Livebirths Not Crying by 30 Seconds Who Receive BMV</measure>
      <time_frame>First hour after birth</time_frame>
      <description>In addition to time to BMV, a dichotomous variable of BMV initiation within 60 seconds after birth will be measured. This variable will be collected via direct observation using the Liveborn application.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of Livebirths Not Crying by 60 Seconds Who Receive BMV</measure>
      <time_frame>First hour after birth</time_frame>
      <description>The investigators will measure a dichotomous variable of receipt of BMV at any point during delivery room resuscitation among liveborn infants who do not cry by 60 seconds after birth. This variable will be collected via direct observation using the Liveborn application.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Time from Birth to Heart Rate ≥100 Beats Per Minute</measure>
      <time_frame>First hour after birth</time_frame>
      <description>The investigators will measure the time to HR≥100bpm as a continuous variable among livebirths who have not cried by 30 seconds after birth who have NeoBeat placed. This variable will be collected using NeoBeat.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Median Time from Birth to Heart Rate ≥100 Beats Per Minute</measure>
      <time_frame>First hour after birth</time_frame>
      <description>The investigators will measure the time to HR≥100bpm as a continuous variable among livebirths who have not cried by 30 seconds after birth who have NeoBeat placed. This variable will be collected using NeoBeat.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Time to First Cry among Livebirths Who Have Not Cried by 30 Seconds</measure>
      <time_frame>First hour after birth</time_frame>
      <description>The investigators will measure time from birth to first cry as a continuous variable among liveborn infants who have not cried by 30 seconds after birth. This variable will be collected via direct observation using the Liveborn application.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Median Time to First Cry among Livebirths Who Have Not Cried by 30 Seconds</measure>
      <time_frame>First hour after birth</time_frame>
      <description>The investigators will measure time from birth to first cry as a continuous variable among liveborn infants who have not cried by 30 seconds after birth. This variable will be collected via direct observation using the Liveborn application.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Duration of Suctioning Among Newborns Who Cry By 30 Seconds</measure>
      <time_frame>First hour after birth</time_frame>
      <description>The investigators will also look at the total duration of suctioning among all livebirths who cry by 30 seconds after birth. This variable will be collected via direct observation using the Liveborn application.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Median Duration of Suctioning Among Newborns Who Cry By 30 Seconds</measure>
      <time_frame>First hour after birth</time_frame>
      <description>The investigators will also look at the total duration of suctioning among all livebirths who cry by 30 seconds after birth. This variable will be collected via direct observation using the Liveborn application.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of Livebirths Crying by 30 Seconds Who Are Suctioned for Less than 30 Seconds</measure>
      <time_frame>First hour after birth</time_frame>
      <description>The investigators will also look at a dichotomous variable of the proportion of newborns who receive less than 30 seconds of total suctioning among liveborn infants who cry by 30 seconds after birth. This variable will be collected via direct observation using the Liveborn application.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of Livebirths Who Have Died by 24 Hours After Birth</measure>
      <time_frame>Between birth and 24 hours of age</time_frame>
      <description>The investigators will measure 24-hour newborn mortality as a dichotomous variable for all enrolled newborns. In the participating health facilities, typical length of stay following birth is more than 24 hours. In the rare instance when a newborn is discharged home prior to 24 hours after birth, the investigators will assume the newborn is alive at 24 hours. If the newborn is transferred prior to discharge, the investigators will contact the referral facility to determine 24-hour vital status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of Births Resulting in a Fresh Stillbirth or Neonatal Death in the First 24 hours</measure>
      <time_frame>Between birth and 24 hours of age</time_frame>
      <description>The investigators will define fresh stillbirths based on the provider's documentation in the medical record. The investigators will measure perinatal mortality as a dichotomous variable for all enrolled newborns.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of Stillbirths That Are Misclassified</measure>
      <time_frame>At birth</time_frame>
      <description>The investigators will review the subset of stillbirth cases with heart rate (HR) data from NeoBeat to determine whether the case is stillborn or liveborn based on HR. The investigators will define misclassification as cases identified by a provider as stillborn who have a HR per NeoBeat. The investigators will measure the dichotomous outcome of stillbirth misclassification.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">25150</enrollment>
    <condition>Respiratory Depression Neonatal</condition>
    <arm_group>
      <arm_group_label>Real-time Guidance</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The LIVEBORN app will provide audio-visual guidance to the birth attendant during a resuscitation based on the data inputted by an observer as well as heart rate data from NeoBeat (if used).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Debriefing</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The LIVEBORN app will support birth attendants in debriefing following a resuscitation based on the data inputted by an observer as well as heart rate data from NeoBeat (if used).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>LIVEBORN: A Mobile Health Application (app) for Newborn Resuscitation</intervention_name>
      <description>LIVEBORN is a mobile health application designed to help providers learn from their clinical practice during newborn resuscitation through real-time guidance and debriefing. Using LIVEBORN, an observer can document events during a resuscitation such as the actions of the provider and when the baby cries. A battery-operated heart rate meter, NeoBeat, measures and sends the newborn's heart rate to the LIVEBORN app via Bluetooth. LIVEBORN integrates data from the observer and NeoBeat to provide audio-visual real-time guidance to the provider during a resuscitation. Following the resuscitation, providers can also debrief using LIVEBORN. The app operates on the Android system and is functional off-line, except for the need for an internet connection to upload data to the cloud for research.</description>
      <arm_group_label>Debriefing</arm_group_label>
      <arm_group_label>Real-time Guidance</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>NeoBeat: Heart Rate Meter for Newborn Resuscitation</intervention_name>
      <description>NeoBeat is a low-cost device for the measurement of newborn heart rate (HR) that was developed by Laerdal Global Health for use in low-resource settings. It is applied by placing the device around the torso of the newborn. It detects HR accurately, quickly (&lt;5 sec), is reusable and can be easily disinfected. NeoBeat's dry electrodes detect HR which is digitally displayed and recorded. It uses an impedance system to sense skin contact and motion detection to validate signal quality. It does not require the use of buttons, adhesive, gel or cables and has no disposable parts. A single birth attendant can apply NeoBeat in 2-3 seconds.</description>
      <arm_group_label>Debriefing</arm_group_label>
      <arm_group_label>Real-time Guidance</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Newborns admitted to a participating health facility who meet the following criteria:&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            -  All in-born neonates, either liveborn or intrapartum (i.e., fresh) stillborn,&#xD;
               regardless of multiple gestation or maternal complication.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Less than 28 weeks completed gestation (or if gestational age is unknown, birth weight&#xD;
               &lt;1,000 grams),&#xD;
  &#xD;
            -  outborn,&#xD;
  &#xD;
            -  known congenital anomaly,&#xD;
  &#xD;
            -  antepartum (i.e., macerated) stillbirth.&#xD;
  &#xD;
          Nurse midwives employed at a participating health facility who meet the following criteria:&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            -  All midwives and nurses functioning in the role of a midwife who care for newborns at&#xD;
               the time of birth during the course of their regular employment.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Unwillingness to consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jackie Patterson, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of North Carolina, Chapel Hill</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jackie Patterson, MD, MPH</last_name>
      <phone>984-974-7855</phone>
      <email>jackie_patterson@med.unc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Binza</name>
        <address>
          <city>Kinshasa</city>
          <country>Congo, The Democratic Republic of the</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Godefroid Luyeye</last_name>
        <phone>(+243) 899319746</phone>
        <email>binzaadoratrice@yahoo.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Bondo</name>
        <address>
          <city>Kinshasa</city>
          <country>Congo, The Democratic Republic of the</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hélène Tambu</last_name>
        <phone>(+243) 85165890</phone>
        <email>helenetambu307@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Bumbu</name>
        <address>
          <city>Kinshasa</city>
          <country>Congo, The Democratic Republic of the</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alain Kabakele</last_name>
        <phone>(+243) 899122690</phone>
        <email>akabakele@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Kingasani</name>
        <address>
          <city>Kinshasa</city>
          <country>Congo, The Democratic Republic of the</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daba Clotilde</last_name>
        <phone>(+243) 813297398</phone>
        <email>dabaclotilde1@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ndjili</name>
        <address>
          <city>Kinshasa</city>
          <country>Congo, The Democratic Republic of the</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mago Magoga</last_name>
        <phone>(+243) 810621099</phone>
        <email>magomagoga1@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Saint Gabriel</name>
        <address>
          <city>Kinshasa</city>
          <country>Congo, The Democratic Republic of the</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gabriel Mabengo</last_name>
        <phone>(+243) 816897669</phone>
        <email>gmabengo@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Congo, The Democratic Republic of the</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Resuscitation</keyword>
    <keyword>Helping Babies Breathe</keyword>
    <keyword>Debriefing</keyword>
    <keyword>Real-Time Guidance</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Insufficiency</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>A de-identified dataset will be posted onto a suitable publicly available archive.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Data will be made indefinitely available no later than the acceptance for publication of the main findings from the final dataset.</ipd_time_frame>
      <ipd_access_criteria>In accordance with the selected public website criteria.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05963516
  org study id: 23-0267
  secondary id: R33HD103058
  secondary id: IGHID 12309
  nct id: NCT05963516
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Purpose: To evaluate the effectiveness of newborn resuscitation feedback supported by a
        mobile health application called LIVEBORN; secondarily, to evaluate the relative
        effectiveness of real-time guidance vs debriefing.
  
        Participants: Newborns and Nurse midwives
  
        Procedures (methods): This is a pre-post interventional trial to evaluate the effectiveness
        of LIVEBORN feedback. The investigators will use a randomized design to test the relative
        effectiveness of two modes of feedback: real-time guidance versus debriefing. Given the
        potential for feedback interventions to have spillover effects, the investigators will
        randomize by cluster (i.e., facility) rather than by individual. The study will begin with an
        approximately two-month pilot phase to establish systems for implementation of recommended
        training and simulation practice and consistent use of LIVEBORN for observations. After these
        systems have been successfully established, the investigators will initiate the pre-post
        trial. The control phase will last six months followed by implementation of LIVEBORN feedback
        in an intervention phase lasting 12 months.
  Study Sites:
  
        the investigators will conduct this pre-post interventional trial in six health facilities in
        Kinshasa, Democratic Republic of the Congo (DRC).
  
        Pilot Phase:
  
        The purpose of the pilot phase is to establish systems to ensure 1) implementation of
        recommended training and simulation practice and 2) consistent use of LIVEBORN for
        observations. The pilot phase will last approximately two months. Any facilities deemed
        facile with LIVEBORN will be exempted from the pilot phase.
  
        Establishment of a System for Implementation of Recommended Training and Simulation Practice:
        During the pilot phase, the investigators will work with each facility to ensure a system for
        implementation of recommended resuscitation training and low-dose high-frequency (LDHF)
        practice of bag-mask ventilation (BMV).
  
        Basic Resuscitation Training: The investigators will train all nurse midwives in basic
        resuscitation using Helping Babies Breathe (HBB) 2.0 materials adapted to include the use of
        NeoBeat, a battery-operated heart rate (HR) meter. In addition to reviewing the
        evidence-based HBB resuscitation algorithm, research staff will orient nurse midwives to use
        of NeoBeat. The training will also include how to use HR to accurately distinguish liveborn
        from stillborn infants. The investigators will recommend that nurse midwives use NeoBeat for
        high-risk pregnancies and newborns not crying by 30 seconds.
  
        Establishment of a System for Consistent Use of LIVEBORN for Observations: During the pilot
        phase, the investigators will work with each facility to ensure a system for consistent use
        of LIVEBORN for observations. This system will include placement of NeoBeat on newborns
        requiring resuscitation.
  
        The investigators will use an established participatory research methodology called trials of
        improved practices (TIPs) which the investigators successfully used in the R21 phase of this
        work to design a strategy for consistent use of LIVEBORN for observations. At each facility,
        the investigators will conduct a strategy development session with facility leadership such
        as the head nurse midwife to develop an initial strategy for implementation of LIVEBORN. Each
        health facility will implement the locally-developed initial strategy in a small-scale test
        for approximately three weeks. Throughout the small-scale test, the investigators will
        rapidly analyze data and identify barriers to implementation of the strategy as well as
        potential solutions. The investigators will refine the strategy in additional cycles of TIPs
        (strategy development, small-scale testing, rapid analysis) until the investigators have
        identified a feasible strategy to move into the control phase.
  
        Control Phase:
  
        The purpose of the control phase is to gather detailed, prospective data on resuscitation
        care and newborn outcomes while implementing recommended practice. During a six-month control
        phase, midwives will implement HBB in their clinical practice with LDHF simulation practice
        of BMV. LDHF practice will occur at regular intervals per the system set up during the pilot
        phase. Nurse midwives will place NeoBeat on newborns that they anticipate resuscitating.
  
        Data Collection: Research staff will conduct medical record abstraction to document clinical
        data for each eligible newborn including such elements as maternal parity and age, birth date
        and time, infant gestational age, birth weight, mode of delivery, stillborn or liveborn,
        alive or dead at discharge (including date of death). As in the pilot phase, trained
        observers (research staff, midwives, and other designated observers per the strategy
        developed in the pilot phase) will conduct observations of resuscitations for a convenience
        sample of births using the LIVEBORN app. If NeoBeat is placed on the newborn, the
        investigators will collect ECG data.
  
        Preparatory Activities for the Intervention Phase: While in the control phase, the
        investigators will randomize facilities to either real-time guidance or debriefing with
        LIVEBORN in preparation for the intervention phase. Prior to implementation of the
        intervention and towards the end of the control phase, research staff will prepare nurse
        midwives to implement LIVEBORN feedback per their cluster randomized assignment using
        simulation.
  
        Intervention Phase:
  
        The purpose of the intervention phase is to gather prospective data on resuscitation care and
        newborn outcomes during implementation of LIVEBORN feedback. During this 12-month phase,
        nurse midwives will implement LIVEBORN feedback per their cluster-randomized assignment to
        either real-time guidance or debriefing. Additionally, nurse midwives will continue all study
        procedures from the control phase, including implementation of HBB with LDHF practice, use of
        NeoBeat on newborns requiring resuscitation, and observation of births using LIVEBORN.
  
        Implementation of LIVEBORN Feedback: At facilities randomized to real-time guidance, midwives
        will be supported by audio-visual feedback from LIVEBORN during the convenience sample of
        resuscitations observed with LIVEBORN. At facilities randomized to debriefing, midwives will
        debrief with LIVEBORN for at least 50% of the convenience sample of resuscitations observed
        with LIVEBORN that involved a newborn not crying by 60 seconds after birth and/or the receipt
        of BMV.
  
        Data Collection: As in the control phase, research staff will conduct medical record
        abstraction to document clinical data for each enrolled. As in the pilot and control phases,
        trained observers (research staff, midwives, and other designated observers per the strategy
        developed in the pilot phase) will conduct observations of resuscitations for a convenience
        sample of births using the LIVEBORN app. If NeoBeat is placed on the newborn, the
        investigators will collect ECG data. At the end of the intervention, five midwives & the head
        nurse midwife from each facility will complete surveys consisting of 4-item quantitative
        scales to evaluate feasibility and acceptability using the Feasibility of Intervention
        Measure (FIM) and Acceptability of Intervention Measure (AIM).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Mean Duration of Suctioning Among Newborns Not Crying By 30 Seconds
  time frame: First hour after birth
  description: The investigators will measure duration of suctioning as a continuous variable among liveborn neonates who are not crying by 30 seconds. This variable will be collected via direct observation using the Liveborn application.
  measure: Median Duration of Suctioning Among Newborns Not Crying By 30 Seconds
  time frame: First hour after birth
  description: The investigators will measure duration of suctioning as a continuous variable among liveborn neonates who are not crying by 30 seconds. This variable will be collected via direct observation using the Liveborn application.
  measure: Suctioned For <30 Seconds Among Newborns Not Crying By 30 Seconds
  time frame: First hour after birth
  description: The investigators will report the proportion of livebirths not crying by 30 seconds who are suctioned for less than 30 seconds. This variable will be collected via direct observation using the Liveborn application.
  measure: Mean Time to Bag Mask Ventilation
  time frame: First hour after birth
  description: The investigators will measure time to BMV as a continuous variable, defining time to BMV as the number of seconds between birth and the start of BMV. They will report time to BMV among all livebirths not crying by 30 seconds who receive BMV. This variable will be collected via direct observation using the Liveborn application.
  measure: Median Time to Bag Mask Ventilation
  time frame: First hour after birth
  description: The investigators will measure time to BMV as a continuous variable, defining time to BMV as the number of seconds between birth and the start of BMV. They will report time to BMV among all livebirths not crying by 30 seconds who receive BMV. This variable will be collected via direct observation using the Liveborn application.
  measure: Proportion of Newborns Who Receive BMV within the Golden Minute Among All Livebirths Not Crying by 30 Seconds Who Receive BMV
  time frame: First hour after birth
  description: In addition to time to BMV, a dichotomous variable of BMV initiation within 60 seconds after birth will be measured. This variable will be collected via direct observation using the Liveborn application.
  measure: Proportion of Livebirths Not Crying by 60 Seconds Who Receive BMV
  time frame: First hour after birth
  description: The investigators will measure a dichotomous variable of receipt of BMV at any point during delivery room resuscitation among liveborn infants who do not cry by 60 seconds after birth. This variable will be collected via direct observation using the Liveborn application.
  measure: Mean Time from Birth to Heart Rate ≥100 Beats Per Minute
  time frame: First hour after birth
  description: The investigators will measure the time to HR≥100bpm as a continuous variable among livebirths who have not cried by 30 seconds after birth who have NeoBeat placed. This variable will be collected using NeoBeat.
  measure: Median Time from Birth to Heart Rate ≥100 Beats Per Minute
  time frame: First hour after birth
  description: The investigators will measure the time to HR≥100bpm as a continuous variable among livebirths who have not cried by 30 seconds after birth who have NeoBeat placed. This variable will be collected using NeoBeat.
  measure: Mean Time to First Cry among Livebirths Who Have Not Cried by 30 Seconds
  time frame: First hour after birth
  description: The investigators will measure time from birth to first cry as a continuous variable among liveborn infants who have not cried by 30 seconds after birth. This variable will be collected via direct observation using the Liveborn application.
  measure: Median Time to First Cry among Livebirths Who Have Not Cried by 30 Seconds
  time frame: First hour after birth
  description: The investigators will measure time from birth to first cry as a continuous variable among liveborn infants who have not cried by 30 seconds after birth. This variable will be collected via direct observation using the Liveborn application.
  measure: Mean Duration of Suctioning Among Newborns Who Cry By 30 Seconds
  time frame: First hour after birth
  description: The investigators will also look at the total duration of suctioning among all livebirths who cry by 30 seconds after birth. This variable will be collected via direct observation using the Liveborn application.
  measure: Median Duration of Suctioning Among Newborns Who Cry By 30 Seconds
  time frame: First hour after birth
  description: The investigators will also look at the total duration of suctioning among all livebirths who cry by 30 seconds after birth. This variable will be collected via direct observation using the Liveborn application.
  measure: Proportion of Livebirths Crying by 30 Seconds Who Are Suctioned for Less than 30 Seconds
  time frame: First hour after birth
  description: The investigators will also look at a dichotomous variable of the proportion of newborns who receive less than 30 seconds of total suctioning among liveborn infants who cry by 30 seconds after birth. This variable will be collected via direct observation using the Liveborn application.
  measure: Proportion of Livebirths Who Have Died by 24 Hours After Birth
  time frame: Between birth and 24 hours of age
  description: The investigators will measure 24-hour newborn mortality as a dichotomous variable for all enrolled newborns. In the participating health facilities, typical length of stay following birth is more than 24 hours. In the rare instance when a newborn is discharged home prior to 24 hours after birth, the investigators will assume the newborn is alive at 24 hours. If the newborn is transferred prior to discharge, the investigators will contact the referral facility to determine 24-hour vital status.
  measure: Proportion of Births Resulting in a Fresh Stillbirth or Neonatal Death in the First 24 hours
  time frame: Between birth and 24 hours of age
  description: The investigators will define fresh stillbirths based on the provider's documentation in the medical record. The investigators will measure perinatal mortality as a dichotomous variable for all enrolled newborns.
  measure: Proportion of Stillbirths That Are Misclassified
  time frame: At birth
  description: The investigators will review the subset of stillbirth cases with heart rate (HR) data from NeoBeat to determine whether the case is stillborn or liveborn based on HR. The investigators will define misclassification as cases identified by a provider as stillborn who have a HR per NeoBeat. The investigators will measure the dichotomous outcome of stillbirth misclassification.
  arm group label: Real-time Guidance
  arm group type: Active Comparator
  description: The LIVEBORN app will provide audio-visual guidance to the birth attendant during a resuscitation based on the data inputted by an observer as well as heart rate data from NeoBeat (if used).
  arm group label: Debriefing
  arm group type: Active Comparator
  description: The LIVEBORN app will support birth attendants in debriefing following a resuscitation based on the data inputted by an observer as well as heart rate data from NeoBeat (if used).
  intervention type: Other
  intervention name: LIVEBORN: A Mobile Health Application (app) for Newborn Resuscitation
  description: LIVEBORN is a mobile health application designed to help providers learn from their clinical practice during newborn resuscitation through real-time guidance and debriefing. Using LIVEBORN, an observer can document events during a resuscitation such as the actions of the provider and when the baby cries. A battery-operated heart rate meter, NeoBeat, measures and sends the newborn's heart rate to the LIVEBORN app via Bluetooth. LIVEBORN integrates data from the observer and NeoBeat to provide audio-visual real-time guidance to the provider during a resuscitation. Following the resuscitation, providers can also debrief using LIVEBORN. The app operates on the Android system and is functional off-line, except for the need for an internet connection to upload data to the cloud for research.
  arm group label: Debriefing
  arm group label: Real-time Guidance
  intervention type: Device
  intervention name: NeoBeat: Heart Rate Meter for Newborn Resuscitation
  description: NeoBeat is a low-cost device for the measurement of newborn heart rate (HR) that was developed by Laerdal Global Health for use in low-resource settings. It is applied by placing the device around the torso of the newborn. It detects HR accurately, quickly (<5 sec), is reusable and can be easily disinfected. NeoBeat's dry electrodes detect HR which is digitally displayed and recorded. It uses an impedance system to sense skin contact and motion detection to validate signal quality. It does not require the use of buttons, adhesive, gel or cables and has no disposable parts. A single birth attendant can apply NeoBeat in 2-3 seconds.
  arm group label: Debriefing
  arm group label: Real-time Guidance
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jackie Patterson, MD, MPH
  role: Principal Investigator
  affiliation: University of North Carolina, Chapel Hill
  last name: Jackie Patterson, MD, MPH
  phone: 984-974-7855
  email: jackie_patterson@med.unc.edu
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Congo, The Democratic Republic of the
  responsible party type: Sponsor
  mesh term: Respiratory Insufficiency
  sharing ipd: Yes
  ipd description: A de-identified dataset will be posted onto a suitable publicly available archive.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Data will be made indefinitely available no later than the acceptance for publication of the main findings from the final dataset.
  ipd access criteria: In accordance with the selected public website criteria.