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Global Network Implementation of Helping Babies Breathe (HBB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01681017
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : October 14, 2015
Sponsor:
Collaborators:
Laerdal Medical
Indiana University School of Medicine
Christiana Care Health Services
Massachusetts General Hospital
Moi Univeristy
Jawaharlal Nehru Medical College
Lata Medical Research Foundation, Nagpur
RTI International
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health

Tracking Information
First Submitted Date  ICMJE September 4, 2012
First Posted Date  ICMJE September 7, 2012
Last Update Posted Date October 14, 2015
Study Start Date  ICMJE September 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
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. ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
Perinatal Mortality [ Time Frame: Study Duration ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2014)
  • 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. ]
    The difference in the rate of facility-based perinatal mortality, among births ≥1500g pre versus post implementation of HBB/ENC training and equipment.
  • Retention of resuscitation knowledge and skills [ Time Frame: Assessments completed at initial training and refresher training. ]
    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.
  • Number of neonatal resuscitations [ Time Frame: Resuscitation data collected at 6 weeks post-delivery. ]
    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.
  • Delivery room checklist score [ Time Frame: Observations conducted on a monthly basis. ]
    The difference in scores on delivery room checklist (in facilities with > 100 deliveries/year)
  • 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. ]
    The difference in the rate of asphyxia related perinatal mortality, among births ≥1500g pre versus post HBB/ENC training.
  • 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. ]
    The difference in the proportion of health seeking behavior pre versus post HBB/ENC training.
  • 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. ]
    The difference in the proportion of facility deliveries pre versus post HBB/ENC training.
  • 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. ]
    The difference in very early newborn death (within 1 day of birth) pre versus post HBB/ENC training.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
  • In participating facilities, the facility-based perinatal mortality [ Time Frame: Study Duration ]
    The difference in the rate of facility-based perinatal mortality, among births >1500g pre versus post implementation of HBB/ENC training and equipment.
  • In participating facilities, the impact on resuscitation [ Time Frame: Study Duration ]
    The difference in resuscitation knowledge and observed skills in bag and mask ventilation, among births >1500g pre versus post HBB/ENC training and equipment implementation
  • In participating facilities, the number of neonatal resuscitations [ Time Frame: Study Duration ]
    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.
  • In participating facilities, the delivery room checklist [ Time Frame: Study Duration ]
    The difference in scores on delivery room checklist, among births >1500g pre versus post HBB/ENC training and equipment.
  • Asphyxia related perinatal mortality [ Time Frame: Study Duration ]
    The difference in the rate of asphyxia related perinatal mortality, among births >1500g pre versus post HBB/ENC training.
  • Health seeking behavior [ Time Frame: Study Duration ]
    The difference in the proportion of health seeking behavior pre versus post HBB/ENC training.
  • Facility deliveries [ Time Frame: Study Duration ]
    The difference in the proportion of facility deliveries pre versus post HBB/ENC training.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Global Network Implementation of Helping Babies Breathe (HBB)
Official Title  ICMJE Global Network for Women's and Children's Health Research Does Implementation of HELPING BABIES BREATHE (HBB) Save Lives?
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Perinatal Mortality
Intervention  ICMJE
  • Behavioral: HBB/ENC Training and Equipment
    See the detailed description section
  • Other: HBB/ENC supplies
    Staffs associated with participating facilities receive HBB/ENC training and use related equipment.
Study Arms  ICMJE
  • Facilities
    Have appropriate staff trained in HBB and have HBB equipment provided
    Intervention: Other: HBB/ENC supplies
  • Master Trainers
    Receive appropriate HBB training
    Intervention: Behavioral: HBB/ENC Training and Equipment
  • Facilitators
    Receive appropriate HBB training
    Intervention: Behavioral: HBB/ENC Training and Equipment
  • Learners
    Receive appropriate HBB training
    Intervention: Behavioral: HBB/ENC Training and Equipment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2015)
70704
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2012)
30000
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Facilities:

    • at least 60 deliveries per year;
    • ability to provide 24-hour coverage, 7 days per week in the delivery ward; and
    • minimum perinatal mortality rate of 30 per 1000 deliveries in the reference period.

Master Trainers (MT)

  • Experienced teachers and content experts in neonatal resuscitation
  • Trained and/or experienced in education
  • Dedication to learner-focused education
  • Able to give informed consent

Facilitators

  • Experienced in teaching Learners in small groups
  • Experienced in care of newborns
  • Demonstrated understanding of course content
  • Aptitude for teaching
  • Able to give informed consent

Learners

  • Skilled birth attendants with clearly defined responsibilities for attending deliveries at participating facilities
  • Able to give informed consent

Exclusion Criteria:

  • If a facility, master trainer, facilitator, or learner does not meet the above inclusion criteria they are excluded from the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India,   Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01681017
Other Study ID Numbers  ICMJE GN HBB Study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NICHD Global Network for Women's and Children's Health
Study Sponsor  ICMJE NICHD Global Network for Women's and Children's Health
Collaborators  ICMJE
  • Laerdal Medical
  • Indiana University School of Medicine
  • Christiana Care Health Services
  • Massachusetts General Hospital
  • Moi Univeristy
  • Jawaharlal Nehru Medical College
  • Lata Medical Research Foundation, Nagpur
  • RTI International
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Study Director: Linda L. Wright, MD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
PRS Account NICHD Global Network for Women's and Children's Health
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP