Global Network Implementation of Helping Babies Breathe (HBB) (NCT01681017) | Clinical Trial Compass
CompletedNot Applicable
Global Network Implementation of Helping Babies Breathe (HBB)
India, Kenya70,704 participantsStarted 2012-09
Plain-language 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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Trial details
NCT IDNCT01681017
SponsorNICHD Global Network for Women's and Children's Health