Global Network Implementation of Helping Babies Breathe (HBB)

This study is ongoing, but not recruiting participants.
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
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier:
NCT01681017
First received: September 4, 2012
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Perinatal Mortality
Behavioral: HBB/ENC Training and Equipment
Other: HBB/ENC supplies

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Global Network for Women's and Children's Health Research Does Implementation of HELPING BABIES BREATHE (HBB) Save Lives?

Resource links provided by NLM:


Further study details as provided by NICHD Global Network for Women's and Children's Health:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    The difference in very early newborn death (within 1 day of birth) pre versus post HBB/ENC training.


Estimated Enrollment: 30000
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Facilities
Have appropriate staff trained in HBB and have HBB equipment provided
Other: HBB/ENC supplies
Staffs associated with participating facilities receive HBB/ENC training and use related equipment.
Master Trainers
Receive appropriate HBB training
Behavioral: HBB/ENC Training and Equipment
See the detailed description section
Facilitators
Receive appropriate HBB training
Behavioral: HBB/ENC Training and Equipment
See the detailed description section
Learners
Receive appropriate HBB training
Behavioral: HBB/ENC Training and Equipment
See the detailed description section

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681017

Locations
India
Jawaharlal Nehru Medical College
Belgaum, India, 590 010
Lata Medical Research Foundation
Nagpur, India, 440013
Kenya
Moi University School of Medicine
Eldoret, Kenya, 30100
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
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
Investigators
Study Director: Linda L. Wright, MD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

No publications provided by NICHD Global Network for Women's and Children's Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT01681017     History of Changes
Other Study ID Numbers: GN HBB Study
Study First Received: September 4, 2012
Last Updated: January 15, 2014
Health Authority: United States: Federal Government

Keywords provided by NICHD Global Network for Women's and Children's Health:
Perinatal Mortality
Asphyxia
Stillbirth
Neonatal Death
Resuscitation
Helping Babies Breathe
among births greater than one thousand five hundred grams

ClinicalTrials.gov processed this record on October 30, 2014