Global Network for Women's and Children's Health Research Does Implementation of HELPING BABIES BREATHE (HBB) Save Lives?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70,704
- 试验地点
- 6
- 主要终点
- Perinatal Mortality
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Skilled birth attendants with clearly defined responsibilities for attending deliveries at participating facilities
- •Able to give informed consent
排除标准
- •If a facility, master trainer, facilitator, or learner does not meet the above inclusion criteria they are excluded from the study.
结局指标
主要结局
Perinatal Mortality
时间窗: 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.
次要结局
- Facility-based perinatal mortality(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.)
- Delivery room checklist score(Observations conducted on a monthly basis.)
- Facility deliveries(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(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(Assessments completed at initial training and refresher training.)
- Number of neonatal resuscitations(Resuscitation data collected at 6 weeks post-delivery.)
- Asphyxia related perinatal mortality(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.)
- Very early newborn death (within 1 day of birth)(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.)