Global Network Implementation of Helping Babies Breathe (HBB)

Perinatal Mortality Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Perinatal Mortality

• NCT number: NCT01681017
• Study type: Interventional
• Source: NICHD Global Network for Women's and Children's Health
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Completion date: December 2014