Clinical trial NCT01681017: Global Network Implementation of Helping Babies Breathe (HBB)
Official title: Global Network for Women's and Children's Health Research Does Implementation of HELPING BABIES BREATHE (HBB) Save Lives?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Mortality
Keywords: Perinatal Mortality
Asphyxia
Stillbirth
Neonatal Death
Resuscitation
Helping Babies Breathe
among births greater than one thousand five hundred grams
Lead sponsor: NICHD Global Network for Women's and Children's Health
Sponsor class: NETWORK
Collaborators: name: Laerdal Medical
name: Indiana University School of Medicine
name: Christiana Care Health Services
name: Massachusetts General Hospital
name: Moi Univeristy
name: Jawaharlal Nehru Medical College
name: Lata Medical Research Foundation, Nagpur
name: RTI International
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2012-09-07
Enrollment: 70704
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: Perinatal Mortality
timeFrame: 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.
Secondary outcomes:
measure: Facility-based perinatal mortality
timeFrame: 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.
measure: Retention of resuscitation knowledge and skills
timeFrame: Assessments completed at initial training and refresher training.
measure: Number of neonatal resuscitations
timeFrame: Resuscitation data collected at 6 weeks post-delivery.
measure: Delivery room checklist score
timeFrame: Observations conducted on a monthly basis.
measure: Asphyxia related perinatal mortality
timeFrame: 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.
measure: Health seeking behavior
timeFrame: 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.
measure: Facility deliveries
timeFrame: 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.
measure: Very early newborn death (within 1 day of birth)
timeFrame: 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.
Other outcomes:
Locations:
city: Belgaum
country: India
facility: Jawaharlal Nehru Medical College
city: Nagpur
country: India
facility: Lata Medical Research Foundation
city: Eldoret
country: Kenya
facility: Moi University School of Medicine
Study officials:
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Linda L. Wright, MD
role: STUDY_DIRECTOR
References:
citation: Patel A, Bang A, Kurhe K, Bhargav S, Prakash A, Arramraj S, Hibberd PL. Comparison of perinatal outcomes in facilities before and after Global Network's Helping Babies Breathe Implementation Study in Nagpur, India. BMC Pregnancy Childbirth. 2019 Sep 4;19(1):324. doi: 10.1186/s12884-019-2480-7.
citation: Bang A, Patel A, Bellad R, Gisore P, Goudar SS, Esamai F, Liechty EA, Meleth S, Goco N, Niermeyer S, Keenan W, Kamath-Rayne BD, Little GA, Clarke SB, Flanagan VA, Bucher S, Jain M, Mujawar N, Jain V, Rukunga J, Mahantshetti N, Dhaded S, Bhandankar M, McClure EM, Carlo WA, Wright LL, Hibberd PL. Helping Babies Breathe (HBB) training: What happens to knowledge and skills over time? BMC Pregnancy Childbirth. 2016 Nov 22;16(1):364. doi: 10.1186/s12884-016-1141-3.
citation: Bellad RM, Bang A, Carlo WA, McClure EM, Meleth S, Goco N, Goudar SS, Derman RJ, Hibberd PL, Patel A, Esamai F, Bucher S, Gisore P, Wright LL; HBB Study Group. A pre-post study of a multi-country scale up of resuscitation training of facility birth attendants: does Helping Babies Breathe training save lives? BMC Pregnancy Childbirth. 2016 Aug 15;16(1):222. doi: 10.1186/s12884-016-0997-6.
citation: Bang A, Bellad R, Gisore P, Hibberd P, Patel A, Goudar S, Esamai F, Goco N, Meleth S, Derman RJ, Liechty EA, McClure E, Carlo WA, Wright LL. Implementation and evaluation of the Helping Babies Breathe curriculum in three resource limited settings: does Helping Babies Breathe save lives? A study protocol. BMC Pregnancy Childbirth. 2014 Mar 26;14:116. doi: 10.1186/1471-2393-14-116.