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Global Network Implementation of Helping Babies Breathe (HBB)

Global Network for Women's and Children's Health Research Does Implementation of HELPING BABIES BREATHE (HBB) Save Lives?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01681017
Enrollment
70704
Registered
2012-09-07
Start date
2012-09-30
Completion date
2014-12-31
Last updated
2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal Mortality

Keywords

Perinatal Mortality, Asphyxia, Stillbirth, Neonatal Death, Resuscitation, Helping Babies Breathe, among births greater than one thousand five hundred grams

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.

Interventions

BEHAVIORALHBB/ENC Training and Equipment

See the detailed description section

OTHERHBB/ENC supplies

Staffs associated with participating facilities receive HBB/ENC training and use related equipment.

Sponsors

Laerdal Medical
CollaboratorINDUSTRY
Indiana University School of Medicine
CollaboratorOTHER
Christiana Care Health Services
CollaboratorOTHER
Massachusetts General Hospital
CollaboratorOTHER
Moi Univeristy
CollaboratorOTHER
Jawaharlal Nehru Medical College
CollaboratorOTHER
Lata Medical Research Foundation, Nagpur
CollaboratorOTHER
RTI International
CollaboratorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
NICHD Global Network for Women's and Children's Health
Lead SponsorNETWORK

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Perinatal MortalityPerinatal 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.

Secondary

MeasureTime frameDescription
Retention of resuscitation knowledge and skillsAssessments 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 resuscitationsResuscitation 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 scoreObservations conducted on a monthly basis.The difference in scores on delivery room checklist (in facilities with \> 100 deliveries/year)
Facility-based perinatal mortalityPerinatal 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.
Health seeking behaviorData 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 deliveriesData 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)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.
Asphyxia related perinatal mortalityPerinatal 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.

Countries

India, Kenya

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026