| Primary | Mean Duration of Suctioning Among All Live Births | 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. | This outcome applies to live births directly observed. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Mean | Standard Deviation | seconds | | First hour after birth | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention | 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). | | OG003 | Debriefing Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG004 | Debriefing Intervention | 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). | | OG005 | Nurse Midwives | Midwives employed at the healthcare facility who participated in the study. |
| | Units | Counts |
|---|
| Participants | - OG0000
- OG0011031
- OG0021317
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00121.9± 37.9
- OG00215.7± 19.9
- OG00334.1± 39.0
- OG004
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Rate ratio | 0.74 | | | 2-Sided | 95 | 0.73 | 0.75 | | | Intervention phase compared to control phase (reference). Adjusted for birth weight, gestational age, multiplicity, sex, and mode of delivery. | | Superiority | | | | | |
|
| Primary | Median Duration of Suctioning Among All Live Births | 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. | This outcome applies to live births directly observed. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Median | Inter-Quartile Range | seconds | | First hour after birth | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention | 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). |
|
| Secondary | Mean Duration of Suctioning Among Live Births Not Crying By 30 Seconds | The investigators will measure duration of suctioning as a continuous variable among liveborn neonates not crying by 30 seconds. This variable will be collected via direct observation using the Liveborn application. | This outcome applies to live births directly observed who did not cry by 30 seconds after birth. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Mean | Standard Deviation | seconds | | First hour after birth | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention | 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). |
|
| Secondary | Median Duration of Suctioning Among Live Births Not Crying By 30 Seconds | The investigators will measure duration of suctioning as a continuous variable among liveborn neonates not crying by 30 seconds. This variable will be collected via direct observation using the Liveborn application. | This outcome applies to live births directly observed who did not cry by 30 seconds after birth. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Median | Inter-Quartile Range | seconds | | First hour after birth | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention | 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). |
|
| Secondary | Proportion Suctioned For <30 Seconds Among Live Births Not Crying By 30 Seconds | The investigators will report the proportion of live births not crying by 30 seconds who are suctioned for less than 30 seconds. This variable will be collected via direct observation using the Liveborn application. | This outcome applies to live births directly observed who did not cry by 30 seconds after birth. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Number | | proportion of neonates | | First hour after birth | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention | 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). |
|
| Secondary | Mean Time to Bag Mask Ventilation (BMV) Among Live Births Not Crying By 30 Seconds Who Receive BMV | The investigators will measure time to BMV as a continuous variable, defining time to BMV as the number of seconds between birth and the start of BMV. They will report time to BMV among all livebirths not crying by 30 seconds who receive BMV. This variable will be collected via direct observation using the Liveborn application. | This outcome applies to live births directly observed who did not cry by 30 seconds after birth and received bag mask ventilation. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Mean | Standard Deviation | seconds | | First hour after birth | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention |
|
| Secondary | Median Time to Bag Mask Ventilation (BMV) Among Live Births Not Crying By 30 Seconds Who Receive BMV | The investigators will measure time to BMV as a continuous variable, defining time to BMV as the number of seconds between birth and the start of BMV. They will report time to BMV among all livebirths not crying by 30 seconds who receive BMV. This variable will be collected via direct observation using the Liveborn application. | This outcome applies to live births directly observed who did not cry by 30 seconds after birth and received bag mask ventilation. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Median | Inter-Quartile Range | seconds | | First hour after birth | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention |
|
| Secondary | Proportion Who Receive Bag Mask Ventilation (BMV) Within 1 Minute Among Live Births Not Crying By 30 Seconds Who Receive BMV | The investigators will report a dichotomous variable of BMV initiation within 60 seconds after birth. This variable will be collected via direct observation using the Liveborn application. | This outcome applies to live births directly observed who did not cry by 30 seconds after birth and received bag mask ventilation. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Number | | proportion of neonates | | First hour after birth | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention | 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). |
|
| Secondary | Proportion Who Receive Bag Mask Ventilation (BMV) Within 2 Minutes Among Live Births Not Crying By 30 Seconds Who Receive BMV | The investigators will report a dichotomous variable of BMV initiation within 120 seconds after birth. This variable will be collected via direct observation using the Liveborn application. | This outcome applies to live births directly observed who did not cry by 30 seconds after birth and received bag mask ventilation. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Number | | proportion of neonates | | First hour after birth | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention | 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). |
|
| Secondary | Proportion Who Receive Bag Mask Ventilation (BMV) Among Live Births Not Crying By 60 Seconds | The investigators will measure a dichotomous variable of receipt of BMV at any point during delivery room resuscitation among liveborn infants who do not cry by 60 seconds after birth. This variable will be collected via direct observation using the Liveborn application. | This outcome applies to live births directly observed who did not cry by 60 seconds after birth. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Number | | proportion of neonates | | First hour after birth | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention | 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). |
|
| Secondary | Mean Duration of Suctioning Among Live Births Crying By 30 Seconds | The investigators will measure duration of suctioning as a continuous variable among liveborn neonates crying by 30 seconds. This variable will be collected via direct observation using the Liveborn application. | This outcome applies to live births directly observed who cried by 30 seconds after birth. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Mean | Standard Deviation | seconds | | First hour after birth | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention | 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). |
|
| Secondary | Median Duration of Suctioning Among Live Births Crying By 30 Seconds | The investigators will measure duration of suctioning as a continuous variable among liveborn neonates crying by 30 seconds. This variable will be collected via direct observation using the Liveborn application. | This outcome applies to live births directly observed who cried by 30 seconds after birth. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Median | Inter-Quartile Range | seconds | | First hour after birth | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention | 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). |
|
| Secondary | Proportion Suctioned Among Live Births Crying By 30 Seconds | The investigators will report the proportion of livebirths crying by 30 seconds who are suctioned. This variable will be collected via direct observation using the Liveborn application. | This outcome applies to live births directly observed who cried by 30 seconds after birth. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Number | | proportion of neonates | | First hour after birth | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention | 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). |
|
| Secondary | 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 | The investigators will measure the time to HR≥100bpm as a continuous variable among livebirths who have not cried by 30 seconds after birth who have NeoBeat placed. This variable will be collected using NeoBeat. | This outcome applies to live births directly observed who did not cry by 30 seconds after birth, had NeoBeat placed, and had first heart rate < 100 bpm. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Mean | Standard Deviation | seconds | | First hour after birth | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention | |
|
| Secondary | 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 | The investigators will measure the time to HR≥100bpm as a continuous variable among livebirths who have not cried by 30 seconds after birth who have NeoBeat placed. This variable will be collected using NeoBeat. | This outcome applies to live births directly observed who did not cry by 30 seconds after birth, had NeoBeat placed, and had first heart rate < 100 bpm. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Median | Inter-Quartile Range | seconds | | First hour after birth | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention | |
|
| Secondary | Mean Time to First Cry Among Live Births Not Crying By 30 Seconds | The investigators will measure time from birth to first cry as a continuous variable among liveborn infants who have not cried by 30 seconds after birth. This variable will be collected via direct observation using the Liveborn application. | This outcome applies to live births directly observed who did not cry by 30 seconds after birth with non-missing data for time to first cry. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Mean | Standard Deviation | seconds | | First hour after birth | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention | 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). |
|
| Secondary | Median Time to First Cry Among Live Births Not Crying By 30 Seconds | The investigators will measure time from birth to first cry as a continuous variable among liveborn infants who have not cried by 30 seconds after birth. This variable will be collected via direct observation using the Liveborn application. | This outcome applies to live births directly observed who did not cry by 30 seconds after birth with non-missing data for time to first cry. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Median | Inter-Quartile Range | seconds | | First hour after birth | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention | 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). |
|
| Secondary | Proportion of 24-Hour Newborn Mortality Among Live Births | The investigators will measure 24-hour newborn mortality as a dichotomous variable for all enrolled newborns. In the participating Health Facilities, typical length of stay following birth is more than 24 hours. In the rare instance when a newborn is discharged home prior to 24 hours after birth, the investigators will assume the newborn is alive at 24 hours. If the newborn is transferred prior to discharge, the investigators will contact the referral facility to determine 24-hour vital status. | This outcome applies to all live births. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Number | | proportion of neonates | | Between birth and 24 hours of age | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention |
|
| Secondary | Proportion of Perinatal Mortality Among All Births | The investigators will define fresh stillbirths based on the provider's documentation in the medical record. The investigators will measure perinatal mortality as a dichotomous variable for all enrolled newborns. | This outcome applies to all births. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Number | | proportion of neonates | | Between birth and 24 hours of age | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention | 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). |
|
| Secondary | Proportion of Stillborn Misclassification Among Stillbirths Directly Observed at Birth | The investigators will review the subset of stillbirth cases with heart rate (HR) data from NeoBeat to determine whether the case is stillborn or liveborn based on HR. The investigators will define misclassification as cases identified by a provider as stillborn who have a HR per NeoBeat. The investigators will measure the dichotomous outcome of stillbirth misclassification and report the proportion who were misclassified. | This outcome applies to stillbirths directly observed. Newborns with missing gestational age (GA) were excluded from analysis for all outcomes, because categorical GA was used as a fixed effect in the models. Data are reported only for neonates in the control and intervention phases, as this outcome does not apply to pilot neonates or nurse midwives. | Posted | | Number | | proportion of neonates | | At birth | | | | ID | Title | Description |
|---|
| OG000 | Pilot Neonates | During the pilot phase, nurse midwives developed and implemented a strategy for collecting data with the LIVEBORN app and using NeoBeat, the heart rate meter. | | OG001 | Real-time Guidance Control | Resuscitation per standard of care with use of heart rate meter called NeoBeat. | | OG002 | Real-time Guidance Intervention |
|