<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/NCT01681017</url>
  </required_header>
  <id_info>
    <org_study_id>GN HBB Study</org_study_id>
    <nct_id>NCT01681017</nct_id>
  </id_info>
  <brief_title>Global Network Implementation of Helping Babies Breathe (HBB)</brief_title>
  <official_title>Global Network for Women's and Children's Health Research Does Implementation of HELPING BABIES BREATHE (HBB) Save Lives?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NICHD Global Network for Women's and Children's Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laerdal Medical</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Indiana University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Christiana Care Health Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Moi Univeristy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jawaharlal Nehru Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lata Medical Research Foundation, Nagpur</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RTI International</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>NICHD Global Network for Women's and Children's Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this pre-post evaluation is to test the impact on perinatal mortality&#xD;
      (fresh stillbirths or early neonatal deaths) among births &gt; 1500g of training birth&#xD;
      attendants at health facilities in the Helping Babies Breathe (HBB) and Essential Newborn&#xD;
      Care (ENC) curricula. These facilities are located within clusters in the Global Network for&#xD;
      Women's and Children's Health Research sites in Belgaum and Nagpur, India, and Eldoret,&#xD;
      Kenya.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Helping Babies Breathe (HBB) is a training program designed to resuscitate neonates&#xD;
      regardless of where they were born. HBB was developed by the American Academy of Pediatrics&#xD;
      (AAP), the NICHD's Global Network for Women's and Children's Health (GN), the Laerdal&#xD;
      Foundation and their global partners. The HBB program was developed based upon the experience&#xD;
      and results of an earlier Neonatal Resuscitation Program and the GN's FIRST BREATH randomized&#xD;
      control trial.&#xD;
&#xD;
      The goal of the study is to test the impact of training birth attendants at selected health&#xD;
      facilities in the Helping Babies Breathe (HBB) and Essential Newborn Care (ENC) curricula&#xD;
      upon perinatal mortality (fresh stillbirths and early neonatal deaths), among births of&#xD;
      ≥1500g. The training will take place in three GN sites, Kenya, and Nagpur and Belgaum, India.&#xD;
      The study facilities serve the population in identified study clusters, defined geographic&#xD;
      areas which participate in the GN's Maternal Newborn Health (MNH) Registry. In addition to&#xD;
      measuring perinatal mortality rate pre and post training, the study will also assess&#xD;
      resuscitation skills among the birth attendants as a result of the training. Quality&#xD;
      Improvement activities are planned to ensure the integrity of the training, maintenance and&#xD;
      availability of resuscitation equipment and skills maintenance.&#xD;
&#xD;
      The GN MNH Registry (NCT 01073475) was established in 2008 and includes all pregnancies and&#xD;
      neonatal outcomes in defined geographic clusters. The primary outcome for the pre-post HBB&#xD;
      evaluation study will be calculated using all delivery data from the GN MNH Registry for&#xD;
      participating clusters during the defined study period.&#xD;
&#xD;
      The pre-post HBB evaluation will include the following key activities:&#xD;
&#xD;
        1. Selection of Master Trainers, Facilitators, and Learners&#xD;
&#xD;
        2. Country-level training of Master Trainers in the HBB and ENC curricula&#xD;
&#xD;
        3. Facility-level training of birth attendants in the HBB and ENC curricula&#xD;
&#xD;
        4. Periodic re-training of birth attendants in the HBB and ENC curricula&#xD;
&#xD;
        5. Quality improvement activities:&#xD;
&#xD;
             -  Regular observation of deliveries in participating study health facilities&#xD;
&#xD;
             -  Unannounced observation of deliveries (or HBB skills using a neonatal simulator if&#xD;
                no deliveries are available)&#xD;
&#xD;
             -  Resuscitation debriefings&#xD;
&#xD;
             -  Perinatal Death audits&#xD;
&#xD;
             -  Daily bag and mask ventilation practice&#xD;
&#xD;
             -  Drills to practice emergency drills&#xD;
&#xD;
             -  Daily check of cleanliness and availability of resuscitation equipment.&#xD;
&#xD;
      The HBB Master Trainers (MT), Facilitators, and Learners will be evaluated at several points&#xD;
      during the implementation of the training program and quality improvement activities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perinatal Mortality</measure>
    <time_frame>Perinatal mortality data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months.</time_frame>
    <description>The difference in the rate of perinatal mortality (fresh stillbirth or neonatal death prior to 7 days) among births ≥1500g, pre versus post implementation of an integrated package of HBB and ENC training and equipment (referred to as HBB/ENC training and equipment). This measure will be calculated using delivery data from the Global Network's Maternal Newborn Health Registry for participating clusters.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Facility-based perinatal mortality</measure>
    <time_frame>Perinatal mortality data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months.</time_frame>
    <description>The difference in the rate of facility-based perinatal mortality, among births ≥1500g pre versus post implementation of HBB/ENC training and equipment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retention of resuscitation knowledge and skills</measure>
    <time_frame>Assessments completed at initial training and refresher training.</time_frame>
    <description>The difference pre versus post intervention in mean scores on a multiple choice test of resuscitation knowledge, observed skills in bag and mask ventilation (BMV), and OSCE A and OSCE B scenarios.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of neonatal resuscitations</measure>
    <time_frame>Resuscitation data collected at 6 weeks post-delivery.</time_frame>
    <description>The difference in the number of neonatal resuscitations, among births ≥1500g with bag and mask in participating facilities pre versus post HBB/ENC training and equipment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delivery room checklist score</measure>
    <time_frame>Observations conducted on a monthly basis.</time_frame>
    <description>The difference in scores on delivery room checklist (in facilities with &gt; 100 deliveries/year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asphyxia related perinatal mortality</measure>
    <time_frame>Perinatal mortality data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months.</time_frame>
    <description>The difference in the rate of asphyxia related perinatal mortality, among births ≥1500g pre versus post HBB/ENC training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health seeking behavior</measure>
    <time_frame>Data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months.</time_frame>
    <description>The difference in the proportion of health seeking behavior pre versus post HBB/ENC training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Facility deliveries</measure>
    <time_frame>Data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months.</time_frame>
    <description>The difference in the proportion of facility deliveries pre versus post HBB/ENC training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Very early newborn death (within 1 day of birth)</measure>
    <time_frame>Data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months.</time_frame>
    <description>The difference in very early newborn death (within 1 day of birth) pre versus post HBB/ENC training.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">70704</enrollment>
  <condition>Perinatal Mortality</condition>
  <arm_group>
    <arm_group_label>Facilities</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Have appropriate staff trained in HBB and have HBB equipment provided</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Master Trainers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Receive appropriate HBB training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Facilitators</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Receive appropriate HBB training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Learners</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Receive appropriate HBB training</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HBB/ENC Training and Equipment</intervention_name>
    <description>See the detailed description section</description>
    <arm_group_label>Facilitators</arm_group_label>
    <arm_group_label>Learners</arm_group_label>
    <arm_group_label>Master Trainers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HBB/ENC supplies</intervention_name>
    <description>Staffs associated with participating facilities receive HBB/ENC training and use related equipment.</description>
    <arm_group_label>Facilities</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Facilities:&#xD;
&#xD;
               -  at least 60 deliveries per year;&#xD;
&#xD;
               -  ability to provide 24-hour coverage, 7 days per week in the delivery ward; and&#xD;
&#xD;
               -  minimum perinatal mortality rate of 30 per 1000 deliveries in the reference&#xD;
                  period.&#xD;
&#xD;
        Master Trainers (MT)&#xD;
&#xD;
          -  Experienced teachers and content experts in neonatal resuscitation&#xD;
&#xD;
          -  Trained and/or experienced in education&#xD;
&#xD;
          -  Dedication to learner-focused education&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
        Facilitators&#xD;
&#xD;
          -  Experienced in teaching Learners in small groups&#xD;
&#xD;
          -  Experienced in care of newborns&#xD;
&#xD;
          -  Demonstrated understanding of course content&#xD;
&#xD;
          -  Aptitude for teaching&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
        Learners&#xD;
&#xD;
          -  Skilled birth attendants with clearly defined responsibilities for attending&#xD;
             deliveries at participating facilities&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If a facility, master trainer, facilitator, or learner does not meet the above&#xD;
             inclusion criteria they are excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linda L. Wright, MD</last_name>
    <role>Study Director</role>
    <affiliation>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jawaharlal Nehru Medical College</name>
      <address>
        <city>Belgaum</city>
        <zip>590 010</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lata Medical Research Foundation</name>
      <address>
        <city>Nagpur</city>
        <zip>440013</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moi University School of Medicine</name>
      <address>
        <city>Eldoret</city>
        <zip>30100</zip>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
    <country>Kenya</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>October 13, 2015</last_update_submitted>
  <last_update_submitted_qc>October 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Perinatal Mortality</keyword>
  <keyword>Asphyxia</keyword>
  <keyword>Stillbirth</keyword>
  <keyword>Neonatal Death</keyword>
  <keyword>Resuscitation</keyword>
  <keyword>Helping Babies Breathe</keyword>
  <keyword>among births greater than one thousand five hundred grams</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Perinatal Death</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01681017
org study id: GN HBB Study
nct id: NCT01681017
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The primary purpose of this pre-post evaluation is to test the impact on perinatal mortality
      (fresh stillbirths or early neonatal deaths) among births > 1500g of training birth
      attendants at health facilities in the Helping Babies Breathe (HBB) and Essential Newborn
      Care (ENC) curricula. These facilities are located within clusters in the Global Network for
      Women's and Children's Health Research sites in Belgaum and Nagpur, India, and Eldoret,
      Kenya.
Helping Babies Breathe (HBB) is a training program designed to resuscitate neonates
      regardless of where they were born. HBB was developed by the American Academy of Pediatrics
      (AAP), the NICHD's Global Network for Women's and Children's Health (GN), the Laerdal
      Foundation and their global partners. The HBB program was developed based upon the experience
      and results of an earlier Neonatal Resuscitation Program and the GN's FIRST BREATH randomized
      control trial.

      The goal of the study is to test the impact of training birth attendants at selected health
      facilities in the Helping Babies Breathe (HBB) and Essential Newborn Care (ENC) curricula
      upon perinatal mortality (fresh stillbirths and early neonatal deaths), among births of
      ≥1500g. The training will take place in three GN sites, Kenya, and Nagpur and Belgaum, India.
      The study facilities serve the population in identified study clusters, defined geographic
      areas which participate in the GN's Maternal Newborn Health (MNH) Registry. In addition to
      measuring perinatal mortality rate pre and post training, the study will also assess
      resuscitation skills among the birth attendants as a result of the training. Quality
      Improvement activities are planned to ensure the integrity of the training, maintenance and
      availability of resuscitation equipment and skills maintenance.

      The GN MNH Registry (NCT 01073475) was established in 2008 and includes all pregnancies and
      neonatal outcomes in defined geographic clusters. The primary outcome for the pre-post HBB
      evaluation study will be calculated using all delivery data from the GN MNH Registry for
      participating clusters during the defined study period.

      The pre-post HBB evaluation will include the following key activities:

        1. Selection of Master Trainers, Facilitators, and Learners

        2. Country-level training of Master Trainers in the HBB and ENC curricula

        3. Facility-level training of birth attendants in the HBB and ENC curricula

        4. Periodic re-training of birth attendants in the HBB and ENC curricula

        5. Quality improvement activities:

             -  Regular observation of deliveries in participating study health facilities

             -  Unannounced observation of deliveries (or HBB skills using a neonatal simulator if
                no deliveries are available)

             -  Resuscitation debriefings

             -  Perinatal Death audits

             -  Daily bag and mask ventilation practice

             -  Drills to practice emergency drills

             -  Daily check of cleanliness and availability of resuscitation equipment.

      The HBB Master Trainers (MT), Facilitators, and Learners will be evaluated at several points
      during the implementation of the training program and quality improvement activities.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Perinatal Mortality
time frame: Perinatal mortality data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months.
description: The difference in the rate of perinatal mortality (fresh stillbirth or neonatal death prior to 7 days) among births ≥1500g, pre versus post implementation of an integrated package of HBB and ENC training and equipment (referred to as HBB/ENC training and equipment). This measure will be calculated using delivery data from the Global Network's Maternal Newborn Health Registry for participating clusters.
measure: Facility-based perinatal mortality
time frame: Perinatal mortality data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months.
description: The difference in the rate of facility-based perinatal mortality, among births ≥1500g pre versus post implementation of HBB/ENC training and equipment.
measure: Retention of resuscitation knowledge and skills
time frame: Assessments completed at initial training and refresher training.
description: The difference pre versus post intervention in mean scores on a multiple choice test of resuscitation knowledge, observed skills in bag and mask ventilation (BMV), and OSCE A and OSCE B scenarios.
measure: Number of neonatal resuscitations
time frame: Resuscitation data collected at 6 weeks post-delivery.
description: The difference in the number of neonatal resuscitations, among births ≥1500g with bag and mask in participating facilities pre versus post HBB/ENC training and equipment.
measure: Delivery room checklist score
time frame: Observations conducted on a monthly basis.
description: The difference in scores on delivery room checklist (in facilities with > 100 deliveries/year)
measure: Asphyxia related perinatal mortality
time frame: Perinatal mortality data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months.
description: The difference in the rate of asphyxia related perinatal mortality, among births ≥1500g pre versus post HBB/ENC training.
measure: Health seeking behavior
time frame: Data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months.
description: The difference in the proportion of health seeking behavior pre versus post HBB/ENC training.
measure: Facility deliveries
time frame: Data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months.
description: The difference in the proportion of facility deliveries pre versus post HBB/ENC training.
measure: Very early newborn death (within 1 day of birth)
time frame: Data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months.
description: The difference in very early newborn death (within 1 day of birth) pre versus post HBB/ENC training.
arm group label: Facilities
arm group type: Other
description: Have appropriate staff trained in HBB and have HBB equipment provided
arm group label: Master Trainers
arm group type: Other
description: Receive appropriate HBB training
arm group label: Facilitators
arm group type: Other
description: Receive appropriate HBB training
arm group label: Learners
arm group type: Other
description: Receive appropriate HBB training
intervention type: Behavioral
intervention name: HBB/ENC Training and Equipment
description: See the detailed description section
arm group label: Facilitators
arm group label: Learners
arm group label: Master Trainers
intervention type: Other
intervention name: HBB/ENC supplies
description: Staffs associated with participating facilities receive HBB/ENC training and use related equipment.
arm group label: Facilities
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Linda L. Wright, MD
role: Study Director
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
facility: 
facility: 
facility: 
country: India
country: Kenya
responsible party type: Sponsor
mesh term: Perinatal Death