Global Network Implementation of Helping Babies Breathe (HBB)

NICHD Global Network for Women's and Children's Health

Status: Completed

Conditions: Perinatal Mortality

Treatments: Other: HBB/ENC supplies; Behavioral: HBB/ENC Training and Equipment

Study type: Interventional

Funder types: Other; NETWORK; Industry; NIH

Identifiers

NCT01681017

GN HBB Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70,704 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70,704 participants in 4 patient groups

Facilities

Other group

Description:

Have appropriate staff trained in HBB and have HBB equipment provided

Treatment:

Other: HBB/ENC supplies

Master Trainers

Other group

Description:

Receive appropriate HBB training

Treatment:

Behavioral: HBB/ENC Training and Equipment

Facilitators

Other group

Description:

Receive appropriate HBB training

Treatment:

Behavioral: HBB/ENC Training and Equipment

Learners

Other group

Description:

Receive appropriate HBB training

Treatment:

Behavioral: HBB/ENC Training and Equipment