<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/NCT03799861</url>
  </required_header>
  <id_info>
    <org_study_id>7200AA18FA00010</org_study_id>
    <nct_id>NCT03799861</nct_id>
  </id_info>
  <brief_title>Newborn Heart Rate as a Catalyst for Improved Survival</brief_title>
  <official_title>Newborn Heart Rate as a Catalyst for Improved Survival (NeoBeat Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American Academy of Pediatrics</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kinshasa School of Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Laerdal Global Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RTI International</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Thrasher Research Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Saving Lives at Birth</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>American Academy of Pediatrics</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Heart rate (HR) is not routinely assessed during newborn resuscitations in low- and&#xD;
      lower-middle income countries (LMICs). Many non-breathing newborns classified as fresh&#xD;
      stillbirths have a heartbeat and are live born. The effect of a low-cost monitor for&#xD;
      measuring HR on the problem of misclassification of stillbirths in LMICs is unknown.&#xD;
&#xD;
      Knowledge of HR during newborn resuscitation might also result in timely administration of&#xD;
      appropriate interventions, and improvement in outcomes. Helping Babies Breathe (HBB), a&#xD;
      resuscitation algorithm developed by the American Academy of Pediatrics (AAP), is widely&#xD;
      accepted as the standard of care for newborn resuscitation in low-resource settings. In&#xD;
      keeping with the International Liaison Committee on Resuscitation (ILCOR) recommendations&#xD;
      that HR be measured during newborn resuscitation, HBB calls for HR assessment after 1 minute&#xD;
      of positive-pressure ventilation with good chest movement (or sooner if there is a helper who&#xD;
      can palpate/auscultate heart rate). However, given the frequent reality of a single provider&#xD;
      attending deliveries in LMICs, as well as the currently available methods for assessing HR&#xD;
      (i.e. palpitation or auscultation), assessment of HR is challenging to perform without&#xD;
      delaying or stopping the provision of other life-saving interventions such as bag and mask&#xD;
      ventilation. The effect of low-cost, continuous HR monitoring to guide resuscitation in these&#xD;
      settings is unknown.&#xD;
&#xD;
      NeoBeat is a low-cost, battery-operated device designed by Laerdal Global Health for the&#xD;
      measurement of newborn HR. The device can be placed rapidly on a newborn by a single&#xD;
      provider, and within 5 seconds, displays HR digitally. A preliminary trial of NeoBeat in 349&#xD;
      non-breathing newborns in Tanzania detected a HR in 67% of newborns classified as&#xD;
      stillbirths, suggesting up to two thirds of fresh stillbirths may be misclassified in similar&#xD;
      settings.&#xD;
&#xD;
      This trial will evaluate: 1) the effectiveness of HBB in combination with NeoBeat for vital&#xD;
      status detection on reduction of reported stillbirths, and 2) the effectiveness of HR-guided&#xD;
      HBB on effective breathing at 3 minutes.&#xD;
&#xD;
      The primary hypothesis is that implementation of HBB with measurement of HR using NeoBeat&#xD;
      will decrease the reported total stillbirth rate by 15% compared to standard care. The&#xD;
      secondary hypothesis is that implementation of HR-guided HBB will increase the proportion of&#xD;
      newborns not breathing well at birth who are effectively breathing at 3 minutes by 50%&#xD;
      compared to HBB with NeoBeat.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2018</start_date>
  <completion_date type="Actual">October 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Reported Total Stillbirth Rate</measure>
    <time_frame>At delivery</time_frame>
    <description>The total number of stillborn infants (both fresh and macerated) at the facility per 1,000 births, with stillbirth as classified by the delivery attendant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effective, Spontaneous Breathing at 3 Minutes</measure>
    <time_frame>At 3 minutes of life</time_frame>
    <description>Breathing without the assistance of stimulation or bag and mask ventilation at a respiratory rate ≥ 40 breaths per minute with a HR ≥ 100 beats per minute at 32 minutes of life.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fresh Stillbirth Rate</measure>
    <time_frame>At delivery</time_frame>
    <description>Total number of non-breathing newborns without a HR at the time of birth, and without signs of maceration, as determined by the delivery attendant, per 1,000 births.</description>
  </other_outcome>
  <other_outcome>
    <measure>Macerated Stillbirth Rate</measure>
    <time_frame>At delivery</time_frame>
    <description>Total number of non-breathing newborns without a HR at the time of birth, with signs of maceration, as determined by the delivery attendant, per 1,000 births.</description>
  </other_outcome>
  <other_outcome>
    <measure>Neonatal Death Prior to Discharge</measure>
    <time_frame>Up to 28 days of life</time_frame>
    <description>Death of a live born infant during the birth hospitalization, where death occurs prior to discharge or transfer from the facility of birth.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Providers Adhering to Resuscitation Algorithm</measure>
    <time_frame>At delivery</time_frame>
    <description>any number of provider actions to promote resuscitation of the non-breathing newborn such as suctioning, stimulation, bag and mask ventilation and corrective measures to improve bag and mask ventilation in response to newborn respiratory condition or HR as defined in the resuscitation algorithm.</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">24034</enrollment>
  <condition>Stillbirth</condition>
  <condition>Neonatal Respiratory Depression</condition>
  <condition>Neonatal Bradycardia</condition>
  <condition>Neonatal Resuscitation</condition>
  <arm_group>
    <arm_group_label>Epoch 1: Care prior to HBB training</arm_group_label>
    <description>A period of demographic and birth outcome data collection for a retrospective cohort of all infants born in the three study hospitals during the 18 months prior to the start of Epoch 2, reflecting care prior to HBB training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epoch 2: HBB with NeoBeat</arm_group_label>
    <description>Implementation of Helping Babies Breathe training in combination with NeoBeat for detection of HR in non-breathing newborns, after which demographic and birth outcome data will be abstracted from the medical record along with observational data on resuscitation for prospective cohort of all infants born in the three study hospitals for a 9-month period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epoch 3: HR-guided HBB</arm_group_label>
    <description>Implementation of HR-guided Helping Babies Breathe training with NeoBeat for measurement of HR throughout resuscitation of non-breathing newborns, after which demographic and birth outcome data will be abstracted from the medical record along with observational data on resuscitation for a prospective cohort of all infants born in the three study hospitals for a 9-month period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Epoch 2: HBB with NeoBeat</intervention_name>
    <description>At the beginning of Epoch 2, all birth attendants in each of the 3 maternity units will participate in a 2 day workshop in Kinshasa in French that will include instructions regarding use of NeoBeat and training in HBB 2.0. Participants will be introduced to NeoBeat, which will include practice with NeoBeat using the NeoNatalie newborn simulator. This training will be conducted in French using typical adapted training materials for this program that incorporate placement of NeoBeat at appropriate times in the algorithm, including a flipchart and NeoNatalie. Participants will complete the pre and post knowledge check questionnaire for the training as well as the Observed Standardized Clinical Exams (OSCEs) with the incorporation of use of NeoBeat into the OSCEs.</description>
    <arm_group_label>Epoch 2: HBB with NeoBeat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Epoch 3: HR-guided HBB</intervention_name>
    <description>At the beginning of Epoch 3, all birth attendants in each of the 3 maternity units will participate in a 1 day workshop in Kinshasa in French that will instruct them in an adapted, HR-guided HBB algorithm. This training will include simulation with NeoNatalie and NeoBeat. Participants will complete a pre and post knowledge check questionnaire for the training as well as the Observed Standardized Clinical Exams (OSCEs).</description>
    <arm_group_label>Epoch 3: HR-guided HBB</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All newborns delivered at any of the following 3 maternity units in Kinshasa, DRC over 3&#xD;
        years: Bumbu, Kingasani and Binza-Delvaux. The first 18 months of patients enrolled in the&#xD;
        study will be retrospective, while the subsequent 18 months will be prospective. The entire&#xD;
        study population will include non-observed and observed deliveries. Observed deliveries&#xD;
        will be a convenience sample of non-breathing newborns based on availability of study&#xD;
        nurses.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: all newborns delivered via vaginal, assisted or operative delivery at&#xD;
        any of 3 participating maternity units in Kinshasa, Democratic Republic of Congo (DRC),&#xD;
        during the study period will be enrolled. All newborns will be included, regardless of:&#xD;
&#xD;
          -  intrauterine fetal demise&#xD;
&#xD;
          -  birth weight&#xD;
&#xD;
          -  congenital anomalies&#xD;
&#xD;
          -  multiple gestation&#xD;
&#xD;
          -  any maternal complication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Newborns transferred to the maternity unit following delivery at a referral hospital&#xD;
             or in the community&#xD;
&#xD;
          -  Miscarriages, or previable newborns, defined as gestational age &lt;28 weeks (or if&#xD;
             gestational age is unavailable, birth weight &lt;1,000g) at the time of delivery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>28 Weeks</minimum_age>
    <maximum_age>45 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carl Bose, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <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_official>
    <last_name>Sara Berkelhamer, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University at Buffalo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nalini Singhal, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Binza-Delvaux Maternity Hospital</name>
      <address>
        <city>Kinshasa</city>
        <country>Congo, The Democratic Republic of the</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospital Kingasani</name>
      <address>
        <city>Kinshasa</city>
        <country>Congo, The Democratic Republic of the</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mother and Child Hospital Bumbu</name>
      <address>
        <city>Kinshasa</city>
        <country>Congo, The Democratic Republic of the</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Congo, The Democratic Republic of the</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 9, 2018</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neonatal Resuscitation</keyword>
  <keyword>Stillbirth</keyword>
  <keyword>Neonatal Respiratory Depression</keyword>
  <keyword>Neonatal Bradycardia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Stillbirth</mesh_term>
    <mesh_term>Bradycardia</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03799861
org study id: 7200AA18FA00010
nct id: NCT03799861
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Heart rate (HR) is not routinely assessed during newborn resuscitations in low- and
      lower-middle income countries (LMICs). Many non-breathing newborns classified as fresh
      stillbirths have a heartbeat and are live born. The effect of a low-cost monitor for
      measuring HR on the problem of misclassification of stillbirths in LMICs is unknown.

      Knowledge of HR during newborn resuscitation might also result in timely administration of
      appropriate interventions, and improvement in outcomes. Helping Babies Breathe (HBB), a
      resuscitation algorithm developed by the American Academy of Pediatrics (AAP), is widely
      accepted as the standard of care for newborn resuscitation in low-resource settings. In
      keeping with the International Liaison Committee on Resuscitation (ILCOR) recommendations
      that HR be measured during newborn resuscitation, HBB calls for HR assessment after 1 minute
      of positive-pressure ventilation with good chest movement (or sooner if there is a helper who
      can palpate/auscultate heart rate). However, given the frequent reality of a single provider
      attending deliveries in LMICs, as well as the currently available methods for assessing HR
      (i.e. palpitation or auscultation), assessment of HR is challenging to perform without
      delaying or stopping the provision of other life-saving interventions such as bag and mask
      ventilation. The effect of low-cost, continuous HR monitoring to guide resuscitation in these
      settings is unknown.

      NeoBeat is a low-cost, battery-operated device designed by Laerdal Global Health for the
      measurement of newborn HR. The device can be placed rapidly on a newborn by a single
      provider, and within 5 seconds, displays HR digitally. A preliminary trial of NeoBeat in 349
      non-breathing newborns in Tanzania detected a HR in 67% of newborns classified as
      stillbirths, suggesting up to two thirds of fresh stillbirths may be misclassified in similar
      settings.

      This trial will evaluate: 1) the effectiveness of HBB in combination with NeoBeat for vital
      status detection on reduction of reported stillbirths, and 2) the effectiveness of HR-guided
      HBB on effective breathing at 3 minutes.

      The primary hypothesis is that implementation of HBB with measurement of HR using NeoBeat
      will decrease the reported total stillbirth rate by 15% compared to standard care. The
      secondary hypothesis is that implementation of HR-guided HBB will increase the proportion of
      newborns not breathing well at birth who are effectively breathing at 3 minutes by 50%
      compared to HBB with NeoBeat.
observational model: Cohort
time perspective: Prospective
measure: Reported Total Stillbirth Rate
time frame: At delivery
description: The total number of stillborn infants (both fresh and macerated) at the facility per 1,000 births, with stillbirth as classified by the delivery attendant.
measure: Effective, Spontaneous Breathing at 3 Minutes
time frame: At 3 minutes of life
description: Breathing without the assistance of stimulation or bag and mask ventilation at a respiratory rate ≥ 40 breaths per minute with a HR ≥ 100 beats per minute at 32 minutes of life.
measure: Fresh Stillbirth Rate
time frame: At delivery
description: Total number of non-breathing newborns without a HR at the time of birth, and without signs of maceration, as determined by the delivery attendant, per 1,000 births.
measure: Macerated Stillbirth Rate
time frame: At delivery
description: Total number of non-breathing newborns without a HR at the time of birth, with signs of maceration, as determined by the delivery attendant, per 1,000 births.
measure: Neonatal Death Prior to Discharge
time frame: Up to 28 days of life
description: Death of a live born infant during the birth hospitalization, where death occurs prior to discharge or transfer from the facility of birth.
measure: Number of Providers Adhering to Resuscitation Algorithm
time frame: At delivery
description: any number of provider actions to promote resuscitation of the non-breathing newborn such as suctioning, stimulation, bag and mask ventilation and corrective measures to improve bag and mask ventilation in response to newborn respiratory condition or HR as defined in the resuscitation algorithm.
arm group label: Epoch 1: Care prior to HBB training
description: A period of demographic and birth outcome data collection for a retrospective cohort of all infants born in the three study hospitals during the 18 months prior to the start of Epoch 2, reflecting care prior to HBB training.
arm group label: Epoch 2: HBB with NeoBeat
description: Implementation of Helping Babies Breathe training in combination with NeoBeat for detection of HR in non-breathing newborns, after which demographic and birth outcome data will be abstracted from the medical record along with observational data on resuscitation for prospective cohort of all infants born in the three study hospitals for a 9-month period.
arm group label: Epoch 3: HR-guided HBB
description: Implementation of HR-guided Helping Babies Breathe training with NeoBeat for measurement of HR throughout resuscitation of non-breathing newborns, after which demographic and birth outcome data will be abstracted from the medical record along with observational data on resuscitation for a prospective cohort of all infants born in the three study hospitals for a 9-month period.
intervention type: Other
intervention name: Epoch 2: HBB with NeoBeat
description: At the beginning of Epoch 2, all birth attendants in each of the 3 maternity units will participate in a 2 day workshop in Kinshasa in French that will include instructions regarding use of NeoBeat and training in HBB 2.0. Participants will be introduced to NeoBeat, which will include practice with NeoBeat using the NeoNatalie newborn simulator. This training will be conducted in French using typical adapted training materials for this program that incorporate placement of NeoBeat at appropriate times in the algorithm, including a flipchart and NeoNatalie. Participants will complete the pre and post knowledge check questionnaire for the training as well as the Observed Standardized Clinical Exams (OSCEs) with the incorporation of use of NeoBeat into the OSCEs.
arm group label: Epoch 2: HBB with NeoBeat
intervention type: Other
intervention name: Epoch 3: HR-guided HBB
description: At the beginning of Epoch 3, all birth attendants in each of the 3 maternity units will participate in a 1 day workshop in Kinshasa in French that will instruct them in an adapted, HR-guided HBB algorithm. This training will include simulation with NeoNatalie and NeoBeat. Participants will complete a pre and post knowledge check questionnaire for the training as well as the Observed Standardized Clinical Exams (OSCEs).
arm group label: Epoch 3: HR-guided HBB
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 28 Weeks
maximum age: 45 Weeks
healthy volunteers: Accepts Healthy Volunteers
last name: Carl Bose, MD
role: Study Director
affiliation: University of North Carolina, Chapel Hill
last name: Jackie Patterson, MD, MPH
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
last name: Sara Berkelhamer, MD
role: Study Chair
affiliation: University at Buffalo
last name: Nalini Singhal, MD
role: Study Chair
affiliation: University of Calgary
facility: 
facility: 
facility: 
country: Congo, The Democratic Republic of the
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
mesh term: Stillbirth
mesh term: Bradycardia
mesh term: Depression
sharing ipd: Yes