Perinatal MortalityNCT01681017
Global Network Implementation of Helping Babies Breathe (HBB)
A study testing HBB/ENC Training and Equipment and HBB/ENC supplies in people with Perinatal Mortality, run by NICHD Global Network for Women's and Children's Health at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Perinatal Mortality
- What is being tested?
- HBB/ENC Training and Equipment and HBB/ENC supplies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70,704 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- If a facility, master trainer, facilitator, or learner does not meet the above inclusion criteria they are excluded from the study.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
India2 sites
Jawaharlal Nehru Medical College
Belagavi, 590 010
Lata Medical Research Foundation
Nagpur, 440013
About this study
Official title: Global Network for Women's and Children's Health Research Does Implementation of HELPING BABIES BREATHE (HBB) Save Lives?
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.
Read the 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:
- 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.
- Conditions
- Perinatal Mortality
- Being tested
- HBB/ENC Training and Equipment, HBB/ENC supplies
- Keywords
- Perinatal Mortality, Asphyxia, Stillbirth, Neonatal Death, Resuscitation, Helping Babies Breathe, among births greater than one thousand five hundred grams
- Medical subject headings
- Perinatal Death, Asphyxia, Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBB/ENC Training and EquipmentBehavioural
See the detailed description section
HBB/ENC suppliesOther
Staffs associated with participating facilities receive HBB/ENC training and use related equipment.
| Study group | Role | What they receive |
|---|---|---|
| Facilities | Other | Have appropriate staff trained in HBB and have HBB equipment provided Receives: Other: HBB/ENC supplies |
| Master Trainers | Other | Receive appropriate HBB training Receives: Behavioral: HBB/ENC Training and Equipment |
| Facilitators | Other | Receive appropriate HBB training Receives: Behavioral: HBB/ENC Training and Equipment |
| Learners | Other | Receive appropriate HBB training Receives: Behavioral: HBB/ENC Training and Equipment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (8)
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.
Measured: 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.
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.
Measured: Assessments completed at initial training and refresher training.
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.
Measured: Resuscitation data collected at 6 weeks post-delivery.
Delivery room checklist score
The difference in scores on delivery room checklist (in facilities with > 100 deliveries/year)
Measured: Observations conducted on a monthly basis.
Asphyxia related perinatal mortality
The difference in the rate of asphyxia related perinatal mortality, among births ≥1500g pre versus post HBB/ENC training.
Measured: 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.
Health seeking behavior
The difference in the proportion of health seeking behavior pre versus post HBB/ENC training.
Measured: 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.
Facility deliveries
The difference in the proportion of facility deliveries pre versus post HBB/ENC training.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Perinatal MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70,704 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Collaborators
- Laerdal Medical, Indiana University, Christiana Care Health Services, Massachusetts General Hospital, Moi Univeristy, Jawaharlal Nehru Medical College, Lata Medical Research Foundation, Nagpur, RTI International, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Linda L. Wright, MD, Study director, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681017
- Sponsor's protocol ID
- GN HBB Study
- Status last verified
- Oct 2015
- First submitted
- 4 Sep 2012
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31484498Bang 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.
PubMed 27875999Bellad 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.
PubMed 27527831Bang 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.
PubMed 24670013
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Network for Women's and Children's Health Research Does Implementation of HELPING BABIES BREATHE (HBB) Save Lives?
- ClinicalTrials.gov ID
- NCT01681017
- Acronym / sponsor ID
- GN HBB Study
- Conditions
- Perinatal Mortality
- Keywords
- Perinatal Mortality, Asphyxia, Stillbirth, Neonatal Death, Resuscitation, Helping Babies Breathe, among births greater than one thousand five hundred grams
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70,704 participants (actual)
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Collaborators
- Laerdal Medical, Indiana University, Christiana Care Health Services, Massachusetts General Hospital, Moi Univeristy, Jawaharlal Nehru Medical College, Lata Medical Research Foundation, Nagpur, RTI International, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Sep 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Facilities | Other | Other: HBB/ENC suppliesHave appropriate staff trained in HBB and have HBB equipment provided |
| Master Trainers | Other | Behavioral: HBB/ENC Training and EquipmentReceive appropriate HBB training |
| Facilitators | Other | Behavioral: HBB/ENC Training and EquipmentReceive appropriate HBB training |
| Learners | Other | Behavioral: HBB/ENC Training and EquipmentReceive appropriate HBB training |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Facilities:
- Master Trainers (MT)
- Experienced teachers and content experts in neonatal resuscitation
- Trained and/or experienced in education
- Dedication to learner-focused education
Key exclusion criteria (1 listed)
- If a facility, master trainer, facilitator, or learner does not meet the above inclusion criteria they are excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBB/ENC Training and EquipmentSee the detailed description section | Behavioural | Facilitators, Learners, Master Trainers |
| HBB/ENC suppliesStaffs associated with participating facilities receive HBB/ENC training and use related equipment. | Other | Facilities |
Primary outcome
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.
8 secondary outcomes
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.
Retention of resuscitation knowledge and skills
Time frame: Assessments completed at initial training and refresher training.
Number of neonatal resuscitations
Time frame: Resuscitation data collected at 6 weeks post-delivery.
Delivery room checklist score
Time frame: Observations conducted on a monthly basis.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Derived from this study: PubMed 31484498Patel 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.
- Derived from this study: PubMed 27875999Bang 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.
- Derived from this study: PubMed 27527831Bellad 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.
- Derived from this study: PubMed 24670013Bang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda L. Wright, MD study director
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBB/ENC Training and Equipment and HBB/ENC supplies in people with Perinatal Mortality, run by NICHD Global Network for Women's and Children's Health at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India, Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01681017, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.