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?
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01945931 -
Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia
|
N/A | |
Completed |
NCT03590483 -
Outcomes in Spontaneous and ART Twin Pregnancies
|
||
Completed |
NCT00133744 -
Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality
|
Phase 3 | |
Completed |
NCT01115478 -
Malaria in Pregnancy: Nutrition and Immunologic Effects
|
N/A | |
Completed |
NCT00640055 -
Verbal Autopsy to Assess Early Neonatal Death and Stillbirth
|
Phase 4 | |
Terminated |
NCT00536003 -
Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor
|
Phase 3 | |
Completed |
NCT03656237 -
Low-dose High-frequency Training of Facility Health Care Providers in Mali
|
N/A | |
Completed |
NCT00860470 -
Antenatal Micronutrient Supplementation and Infant Survival
|
Phase 3 | |
Completed |
NCT02189265 -
Assessing the Impact of Smoke-free Legislation on Perinatal Health in the Netherlands
|
N/A | |
Completed |
NCT04663620 -
Saving Babies Lives
|
N/A | |
Recruiting |
NCT03108404 -
Predictive Score for Neonatal Mortality for Women With Premature Rupture of Membranes Between 22 and 28 Weeks of Gestation
|
N/A | |
Not yet recruiting |
NCT03398551 -
Machine Learning From Fetal Flow Waveforms to Predict Adverse Perinatal Outcomes
|
N/A |