Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14,680
- 试验地点
- 8
- 主要终点
- Mean Duration of Suctioning Among Newborns Not Crying By 30 Seconds
研究概览
简要总结
Purpose: To evaluate the effectiveness of newborn resuscitation feedback supported by a mobile health application called LIVEBORN; secondarily, to evaluate the relative effectiveness of real-time guidance vs debriefing.
Participants: Newborns and Nurse midwives
Procedures (methods): This is a pre-post interventional trial to evaluate the effectiveness of LIVEBORN feedback. The investigators will use a randomized design to test the relative effectiveness of two modes of feedback: real-time guidance versus debriefing. Given the potential for feedback interventions to have spillover effects, the investigators will randomize by cluster (i.e., facility) rather than by individual. The study will begin with an approximately two-month pilot phase to establish systems for implementation of recommended training and simulation practice and consistent use of LIVEBORN for observations. After these systems have been successfully established, the investigators will initiate the pre-post trial. The control phase will last six months followed by implementation of LIVEBORN feedback in an intervention phase lasting 12 months.
详细描述
Study Sites:
the investigators will conduct this pre-post interventional trial in six health facilities in Kinshasa, Democratic Republic of the Congo (DRC).
Pilot Phase:
The purpose of the pilot phase is to establish systems to ensure 1) implementation of recommended training and simulation practice and 2) consistent use of LIVEBORN for observations. The pilot phase will last approximately two months. Any facilities deemed facile with LIVEBORN will be exempted from the pilot phase.
Establishment of a System for Implementation of Recommended Training and Simulation Practice: During the pilot phase, the investigators will work with each facility to ensure a system for implementation of recommended resuscitation training and low-dose high-frequency (LDHF) practice of bag-mask ventilation (BMV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborns admitted to a participating health facility who meet the following criteria:
- •Inclusion criteria:
- •All in-born neonates, either liveborn or intrapartum (i.e., fresh) stillborn, regardless of multiple gestation or maternal complication.
排除标准
- •Less than 28 weeks completed gestation (or if gestational age is unknown, birth weight <1,000 grams),
- •known congenital anomaly,
- •antepartum (i.e., macerated) stillbirth.
- •Nurse midwives employed at a participating health facility who meet the following criteria:
- •Inclusion criteria:
- •All midwives and nurses functioning in the role of a midwife who care for newborns at the time of birth during the course of their regular employment.
- •Exclusion criteria:
- •Unwillingness to consent
研究组 & 干预措施
Real-time Guidance
The LIVEBORN app will provide audio-visual guidance to the birth attendant during a resuscitation based on the data inputted by an observer as well as heart rate data from NeoBeat (if used).
干预措施: LIVEBORN: A Mobile Health Application (app) for Newborn Resuscitation (Other)
Real-time Guidance
The LIVEBORN app will provide audio-visual guidance to the birth attendant during a resuscitation based on the data inputted by an observer as well as heart rate data from NeoBeat (if used).
干预措施: NeoBeat: Heart Rate Meter for Newborn Resuscitation (Device)
Debriefing
The LIVEBORN app will support birth attendants in debriefing following a resuscitation based on the data inputted by an observer as well as heart rate data from NeoBeat (if used).
干预措施: LIVEBORN: A Mobile Health Application (app) for Newborn Resuscitation (Other)
Debriefing
The LIVEBORN app will support birth attendants in debriefing following a resuscitation based on the data inputted by an observer as well as heart rate data from NeoBeat (if used).
干预措施: NeoBeat: Heart Rate Meter for Newborn Resuscitation (Device)
结局指标
主要结局
Mean Duration of Suctioning Among Newborns Not Crying By 30 Seconds
时间窗: First hour after birth
The investigators will measure duration of suctioning as a continuous variable among liveborn neonates who are not crying by 30 seconds. This variable will be collected via direct observation using the Liveborn application.
Median Duration of Suctioning Among Newborns Not Crying By 30 Seconds
时间窗: First hour after birth
The investigators will measure duration of suctioning as a continuous variable among liveborn neonates who are not crying by 30 seconds. This variable will be collected via direct observation using the Liveborn application.
Mean Duration of Suctioning Among All Live Births
时间窗: First hour after birth
The investigators will measure duration of suctioning as a continuous variable among liveborn neonates. This variable will be collected via direct observation using the Liveborn application.
Median Duration of Suctioning Among All Live Births
时间窗: First hour after birth
The investigators will measure duration of suctioning as a continuous variable among liveborn neonates. This variable will be collected via direct observation using the Liveborn application.
次要结局
- Proportion of Livebirths Not Crying by 60 Seconds Who Receive BMV(First hour after birth)
- Mean Duration of Suctioning Among Newborns Who Cry By 30 Seconds(First hour after birth)
- Suctioned For <30 Seconds Among Newborns Not Crying By 30 Seconds(First hour after birth)
- Mean Time to Bag Mask Ventilation(First hour after birth)
- Median Time to Bag Mask Ventilation(First hour after birth)
- Proportion of Newborns Who Receive BMV within the Golden Minute Among All Livebirths Not Crying by 30 Seconds Who Receive BMV(First hour after birth)
- Median Time from Birth to Heart Rate ≥100 Beats Per Minute(First hour after birth)
- Mean Time to First Cry among Livebirths Who Have Not Cried by 30 Seconds(First hour after birth)
- Median Time to First Cry among Livebirths Who Have Not Cried by 30 Seconds(First hour after birth)
- Mean Time from Birth to Heart Rate ≥100 Beats Per Minute(First hour after birth)
- Median Duration of Suctioning Among Newborns Who Cry By 30 Seconds(First hour after birth)
- Proportion of Livebirths Crying by 30 Seconds Who Are Suctioned for Less than 30 Seconds(First hour after birth)
- Proportion of Livebirths Who Have Died by 24 Hours After Birth(Between birth and 24 hours of age)
- Proportion of Births Resulting in a Fresh Stillbirth or Neonatal Death in the First 24 hours(Between birth and 24 hours of age)
- Proportion of Stillbirths That Are Misclassified(At birth)
- Mean Duration of Suctioning Among Live Births Not Crying By 30 Seconds(First hour after birth)
- Median Duration of Suctioning Among Live Births Not Crying By 30 Seconds(First hour after birth)
- Proportion Suctioned For <30 Seconds Among Live Births Not Crying By 30 Seconds(First hour after birth)
- Mean Time to Bag Mask Ventilation (BMV) Among Live Births Not Crying By 30 Seconds Who Receive BMV(First hour after birth)
- Median Time to Bag Mask Ventilation (BMV) Among Live Births Not Crying By 30 Seconds Who Receive BMV(First hour after birth)
- Proportion Who Receive Bag Mask Ventilation (BMV) Within 1 Minute Among Live Births Not Crying By 30 Seconds Who Receive BMV(First hour after birth)
- Proportion Who Receive Bag Mask Ventilation (BMV) Within 2 Minutes Among Live Births Not Crying By 30 Seconds Who Receive BMV(First hour after birth)
- Proportion Who Receive Bag Mask Ventilation (BMV) Among Live Births Not Crying By 60 Seconds(First hour after birth)
- Mean Duration of Suctioning Among Live Births Crying By 30 Seconds(First hour after birth)
- Median Duration of Suctioning Among Live Births Crying By 30 Seconds(First hour after birth)
- Proportion Suctioned Among Live Births Crying By 30 Seconds(First hour after birth)
- Mean Time to Heart Rate ≥ 100 Beats Per Minute Among Live Births Not Crying By 30 Seconds Who Have NeoBeat Placed and First HR < 100 Bpm(First hour after birth)
- Median Time to Heart Rate ≥ 100 Beats Per Minute Among Live Births Not Crying By 30 Seconds Who Have NeoBeat Placed and First HR < 100 Bpm(First hour after birth)
- Mean Time to First Cry Among Live Births Not Crying By 30 Seconds(First hour after birth)
- Median Time to First Cry Among Live Births Not Crying By 30 Seconds(First hour after birth)
- Proportion of 24-Hour Newborn Mortality Among Live Births(Between birth and 24 hours of age)
- Proportion of Perinatal Mortality Among All Births(Between birth and 24 hours of age)
- Proportion of Stillborn Misclassification Among Stillbirths Directly Observed at Birth(At birth)