Global Network Implementation of Helping Babies Breathe (HBB)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01681017 |
Recruitment Status :
Completed
First Posted : September 7, 2012
Last Update Posted : October 14, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Perinatal Mortality | Behavioral: HBB/ENC Training and Equipment Other: HBB/ENC supplies | Not Applicable |
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:
- Selection of Master Trainers, Facilitators, and Learners
- Country-level training of Master Trainers in the HBB and ENC curricula
- Facility-level training of birth attendants in the HBB and ENC curricula
- Periodic re-training of birth attendants in the HBB and ENC curricula
-
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 70704 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Global Network for Women's and Children's Health Research Does Implementation of HELPING BABIES BREATHE (HBB) Save Lives? |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Facilities
Have appropriate staff trained in HBB and have HBB equipment provided
|
Other: HBB/ENC supplies
Staffs associated with participating facilities receive HBB/ENC training and use related equipment. |
Master Trainers
Receive appropriate HBB training
|
Behavioral: HBB/ENC Training and Equipment
See the detailed description section |
Facilitators
Receive appropriate HBB training
|
Behavioral: HBB/ENC Training and Equipment
See the detailed description section |
Learners
Receive appropriate HBB training
|
Behavioral: HBB/ENC Training and Equipment
See the detailed description section |
- Perinatal Mortality [ Time Frame: 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. ]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.
- Facility-based perinatal mortality [ Time Frame: 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. ]The difference in the rate of facility-based perinatal mortality, among births ≥1500g pre versus post implementation of HBB/ENC training and equipment.
- Retention of resuscitation knowledge and skills [ Time Frame: Assessments 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 resuscitations [ Time Frame: Resuscitation 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 score [ Time Frame: Observations conducted on a monthly basis. ]The difference in scores on delivery room checklist (in facilities with > 100 deliveries/year)
- Asphyxia related perinatal mortality [ Time Frame: 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. ]The difference in the rate of asphyxia related perinatal mortality, among births ≥1500g pre versus post HBB/ENC training.
- Health seeking behavior [ Time Frame: 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 proportion of health seeking behavior pre versus post HBB/ENC training.
- Facility deliveries [ Time Frame: 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 proportion of facility deliveries pre versus post HBB/ENC training.
- Very early newborn death (within 1 day of birth) [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681017
India | |
Jawaharlal Nehru Medical College | |
Belgaum, India, 590 010 | |
Lata Medical Research Foundation | |
Nagpur, India, 440013 | |
Kenya | |
Moi University School of Medicine | |
Eldoret, Kenya, 30100 |
Study Director: | Linda L. Wright, MD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Responsible Party: | NICHD Global Network for Women's and Children's Health |
ClinicalTrials.gov Identifier: | NCT01681017 |
Other Study ID Numbers: |
GN HBB Study |
First Posted: | September 7, 2012 Key Record Dates |
Last Update Posted: | October 14, 2015 |
Last Verified: | October 2015 |
Perinatal Mortality Asphyxia Stillbirth Neonatal Death |
Resuscitation Helping Babies Breathe among births greater than one thousand five hundred grams |
Perinatal Death Pregnancy Complications Death Pathologic Processes |