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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681017
• Other study ID #: GN HBB Study
• Status: Completed
• Phase: N/A
• First received: September 4, 2012
• Last updated: October 13, 2015
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: NICHD Global Network for Women's and Children's Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70704
• Est. completion date: December 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

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

Intervention

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.

Locations

Country	Name	City	State
India	Jawaharlal Nehru Medical College	Belgaum
India	Lata Medical Research Foundation	Nagpur
Kenya	Moi University School of Medicine	Eldoret

Sponsors (10)

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

Countries where clinical trial is conducted

India,  Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perinatal Mortality	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.	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.	No
Secondary	Facility-based perinatal mortality	The difference in the rate of facility-based perinatal mortality, among births =1500g pre versus post implementation of HBB/ENC training and equipment.	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.	No
Secondary	Retention of resuscitation knowledge and skills	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.	Assessments completed at initial training and refresher training.	No
Secondary	Number of neonatal resuscitations	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.	Resuscitation data collected at 6 weeks post-delivery.	No
Secondary	Delivery room checklist score	The difference in scores on delivery room checklist (in facilities with > 100 deliveries/year)	Observations conducted on a monthly basis.	No
Secondary	Asphyxia related perinatal mortality	The difference in the rate of asphyxia related perinatal mortality, among births =1500g pre versus post HBB/ENC training.	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.	No
Secondary	Health seeking behavior	The difference in the proportion of health seeking behavior pre versus post HBB/ENC training.	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.	No
Secondary	Facility deliveries	The difference in the proportion of facility deliveries pre versus post HBB/ENC training.	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.	No
Secondary	Very early newborn death (within 1 day of birth)	The difference in very early newborn death (within 1 day of birth) pre versus post HBB/ENC training.	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.	No