Trial Outcomes & Findings for Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study) (NCT NCT05963516)
NCT ID: NCT05963516
Last Updated: 2026-05-20
Results Overview
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.
COMPLETED
NA
14680 participants
First hour after birth
2026-05-20
Participant Flow
Newborns and nurse midwives were recruited at six health facilities in Kinshasa, DRC. All neonates born at participating facilities were assessed for eligibility and enrolled under a waiver of informed consent. All nurse midwives employed at participating facilities were approached for informed consent at trial start, with newly employed midwives approached during the study. Facility participation across pilot and randomized phases is described in Pre-assignment Details.
Two facilities participated in the pilot phase only and were withdrawn prior to randomization due to prolonged healthcare worker strikes. Two facilities participated in both the pilot and control/intervention phases. Two facilities participated only in the control/intervention phases (excluded from the pilot due to prior LIVEBORN app piloting). The four facilities participating in the intervention phase were randomized 1:1 to real-time guidance or debriefing.
Unit of analysis: Health Facilities
Participant milestones
| Measure |
Pilot
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.
|
Real-time Guidance
During the control phase, nurse midwives performed resuscitation per standard of care with use of a heart rate meter called NeoBeat. During the intervention phase, the LIVEBORN app provided 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).
|
Debriefing
During the control phase, nurse midwives performed resuscitation per standard of care with use of a heart rate meter called NeoBeat. During the intervention phase, the LIVEBORN app supported 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).
|
|---|---|---|---|
|
Pilot Phase (2 Months)
STARTED
|
441 4
|
0 0
|
0 0
|
|
Pilot Phase (2 Months)
Nurse Midwives Started
|
40 4
|
0 0
|
0 0
|
|
Pilot Phase (2 Months)
Neonates Started
|
401 4
|
0 0
|
0 0
|
|
Pilot Phase (2 Months)
Nurse Midwives Completed
|
40 4
|
0 0
|
0 0
|
|
Pilot Phase (2 Months)
Neonates Completed
|
401 4
|
0 0
|
0 0
|
|
Pilot Phase (2 Months)
COMPLETED
|
441 4
|
0 0
|
0 0
|
|
Pilot Phase (2 Months)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Control Phase (6 Months)
STARTED
|
0 0
|
2178 2
|
2662 2
|
|
Control Phase (6 Months)
Nurse Midwives Started
|
0 0
|
24 2
|
30 2
|
|
Control Phase (6 Months)
Neonates Started
|
0 0
|
2154 2
|
2632 2
|
|
Control Phase (6 Months)
Nurse Midwives Completed
|
0 0
|
22 2
|
27 2
|
|
Control Phase (6 Months)
Neonates Completed
|
0 0
|
2154 2
|
2632 2
|
|
Control Phase (6 Months)
COMPLETED
|
0 0
|
2176 2
|
2659 2
|
|
Control Phase (6 Months)
NOT COMPLETED
|
0 0
|
2 0
|
3 0
|
|
Intervention Phase (12 Months)
STARTED
|
0 0
|
3729 2
|
5670 2
|
|
Intervention Phase (12 Months)
Nurse Midwives Started
|
0 0
|
0 0
|
2 2
|
|
Intervention Phase (12 Months)
Neonates Started
|
0 0
|
3729 2
|
5668 2
|
|
Intervention Phase (12 Months)
Nurse Midwives Completed
|
0 0
|
0 0
|
2 2
|
|
Intervention Phase (12 Months)
Neonates Completed
|
0 0
|
3729 2
|
5668 2
|
|
Intervention Phase (12 Months)
COMPLETED
|
0 0
|
3729 2
|
5670 2
|
|
Intervention Phase (12 Months)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sex was not collected for neonates in the Pilot Phase.
Baseline characteristics by cohort
| Measure |
Pilot Neonates
n=401 Participants
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.
|
Real-time Guidance Control Neonates
n=2154 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention Neonates
n=3729 Participants
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).
|
Debriefing Control Neonates
n=2632 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention Neonates
n=5668 Participants
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).
|
Pilot Nurse Midwives
n=40 Participants
Midwives employed at a pilot healthcare facility who participated in the study. There were two healthcare facilities that only participated in the pilot phase.
|
Real-time Guidance Nurse Midwives
n=24 Participants
Midwives employed at a real-time guidance healthcare facility who participated in the study. There were two healthcare facilities randomized to real-time guidance.
|
Debriefing Nurse Midwives
n=32 Participants
Midwives employed at a debriefing healthcare facility who participated in the study. There were two healthcare facilities randomized to debriefing.
|
Total
n=14680 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=401 Participants
|
0 Participants
n=2154 Participants
|
0 Participants
n=3729 Participants
|
0 Participants
n=2632 Participants
|
0 Participants
n=5668 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=14680 Participants
|
|
Sex: Female, Male
Female
|
—
|
1029 Participants
n=2154 Participants • Sex was not collected for neonates in the Pilot Phase.
|
1848 Participants
n=3729 Participants • Sex was not collected for neonates in the Pilot Phase.
|
1276 Participants
n=2632 Participants • Sex was not collected for neonates in the Pilot Phase.
|
2778 Participants
n=5668 Participants • Sex was not collected for neonates in the Pilot Phase.
|
40 Participants
n=40 Participants • Sex was not collected for neonates in the Pilot Phase.
|
24 Participants
n=24 Participants • Sex was not collected for neonates in the Pilot Phase.
|
32 Participants
n=32 Participants • Sex was not collected for neonates in the Pilot Phase.
|
7027 Participants
n=14279 Participants • Sex was not collected for neonates in the Pilot Phase.
|
|
Age, Continuous
|
—
|
—
|
—
|
—
|
—
|
51.0 years
n=40 Participants • Age is reported separately (in weeks) for infants.
|
50.5 years
n=24 Participants • Age is reported separately (in weeks) for infants.
|
41.0 years
n=32 Participants • Age is reported separately (in weeks) for infants.
|
45.0 years
n=96 Participants • Age is reported separately (in weeks) for infants.
|
|
Age, Customized
< 37 weeks
|
—
|
201 Participants
n=2154 Participants • Age is reported separately (in years) for Nurse Midwives. Gestational age was not collected for neonates in the Pilot Phase.
|
363 Participants
n=3729 Participants • Age is reported separately (in years) for Nurse Midwives. Gestational age was not collected for neonates in the Pilot Phase.
|
404 Participants
n=2632 Participants • Age is reported separately (in years) for Nurse Midwives. Gestational age was not collected for neonates in the Pilot Phase.
|
802 Participants
n=5668 Participants • Age is reported separately (in years) for Nurse Midwives. Gestational age was not collected for neonates in the Pilot Phase.
|
—
|
—
|
—
|
1770 Participants
n=14183 Participants • Age is reported separately (in years) for Nurse Midwives. Gestational age was not collected for neonates in the Pilot Phase.
|
|
Age, Customized
>/= 37 weeks
|
—
|
1953 Participants
n=2154 Participants • Age is reported separately (in years) for Nurse Midwives. Gestational age was not collected for neonates in the Pilot Phase.
|
3366 Participants
n=3729 Participants • Age is reported separately (in years) for Nurse Midwives. Gestational age was not collected for neonates in the Pilot Phase.
|
2218 Participants
n=2632 Participants • Age is reported separately (in years) for Nurse Midwives. Gestational age was not collected for neonates in the Pilot Phase.
|
4859 Participants
n=5668 Participants • Age is reported separately (in years) for Nurse Midwives. Gestational age was not collected for neonates in the Pilot Phase.
|
—
|
—
|
—
|
12396 Participants
n=14183 Participants • Age is reported separately (in years) for Nurse Midwives. Gestational age was not collected for neonates in the Pilot Phase.
|
|
Age, Customized
Unknown
|
—
|
0 Participants
n=2154 Participants • Age is reported separately (in years) for Nurse Midwives. Gestational age was not collected for neonates in the Pilot Phase.
|
0 Participants
n=3729 Participants • Age is reported separately (in years) for Nurse Midwives. Gestational age was not collected for neonates in the Pilot Phase.
|
10 Participants
n=2632 Participants • Age is reported separately (in years) for Nurse Midwives. Gestational age was not collected for neonates in the Pilot Phase.
|
7 Participants
n=5668 Participants • Age is reported separately (in years) for Nurse Midwives. Gestational age was not collected for neonates in the Pilot Phase.
|
—
|
—
|
—
|
17 Participants
n=14183 Participants • Age is reported separately (in years) for Nurse Midwives. Gestational age was not collected for neonates in the Pilot Phase.
|
|
Sex: Female, Male
Male
|
—
|
1125 Participants
n=2154 Participants • Sex was not collected for neonates in the Pilot Phase.
|
1881 Participants
n=3729 Participants • Sex was not collected for neonates in the Pilot Phase.
|
1356 Participants
n=2632 Participants • Sex was not collected for neonates in the Pilot Phase.
|
2890 Participants
n=5668 Participants • Sex was not collected for neonates in the Pilot Phase.
|
0 Participants
n=40 Participants • Sex was not collected for neonates in the Pilot Phase.
|
0 Participants
n=24 Participants • Sex was not collected for neonates in the Pilot Phase.
|
0 Participants
n=32 Participants • Sex was not collected for neonates in the Pilot Phase.
|
7252 Participants
n=14279 Participants • Sex was not collected for neonates in the Pilot Phase.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=401 Participants
|
0 Participants
n=2154 Participants
|
0 Participants
n=3729 Participants
|
0 Participants
n=2632 Participants
|
0 Participants
n=5668 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=14680 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
401 Participants
n=401 Participants
|
2154 Participants
n=2154 Participants
|
3729 Participants
n=3729 Participants
|
2632 Participants
n=2632 Participants
|
5668 Participants
n=5668 Participants
|
40 Participants
n=40 Participants
|
24 Participants
n=24 Participants
|
32 Participants
n=32 Participants
|
14680 Participants
n=14680 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=401 Participants
|
0 Participants
n=2154 Participants
|
0 Participants
n=3729 Participants
|
0 Participants
n=2632 Participants
|
0 Participants
n=5668 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=14680 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=401 Participants
|
0 Participants
n=2154 Participants
|
0 Participants
n=3729 Participants
|
0 Participants
n=2632 Participants
|
0 Participants
n=5668 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=14680 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=401 Participants
|
0 Participants
n=2154 Participants
|
0 Participants
n=3729 Participants
|
0 Participants
n=2632 Participants
|
0 Participants
n=5668 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=14680 Participants
|
|
Race (NIH/OMB)
Black or African American
|
401 Participants
n=401 Participants
|
2154 Participants
n=2154 Participants
|
3729 Participants
n=3729 Participants
|
2632 Participants
n=2632 Participants
|
5668 Participants
n=5668 Participants
|
40 Participants
n=40 Participants
|
24 Participants
n=24 Participants
|
32 Participants
n=32 Participants
|
14680 Participants
n=14680 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=401 Participants
|
0 Participants
n=2154 Participants
|
0 Participants
n=3729 Participants
|
0 Participants
n=2632 Participants
|
0 Participants
n=5668 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=14680 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=401 Participants
|
0 Participants
n=2154 Participants
|
0 Participants
n=3729 Participants
|
0 Participants
n=2632 Participants
|
0 Participants
n=5668 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=14680 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=401 Participants
|
0 Participants
n=2154 Participants
|
0 Participants
n=3729 Participants
|
0 Participants
n=2632 Participants
|
0 Participants
n=5668 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=14680 Participants
|
|
Region of Enrollment
Democratic Republic of the Congo
|
401 Participants
n=401 Participants
|
2154 Participants
n=2154 Participants
|
3729 Participants
n=3729 Participants
|
2632 Participants
n=2632 Participants
|
5668 Participants
n=5668 Participants
|
40 Participants
n=40 Participants
|
24 Participants
n=24 Participants
|
32 Participants
n=32 Participants
|
14680 Participants
n=14680 Participants
|
PRIMARY outcome
Timeframe: First hour after birthPopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=1031 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=1317 Participants
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).
|
Debriefing Control
n=1018 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=1408 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
Mean Duration of Suctioning Among All Live Births
|
—
|
21.9 seconds
Standard Deviation 37.9
|
15.7 seconds
Standard Deviation 19.9
|
34.1 seconds
Standard Deviation 39.0
|
23.2 seconds
Standard Deviation 22.4
|
—
|
PRIMARY outcome
Timeframe: First hour after birthPopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=1031 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=1317 Participants
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).
|
Debriefing Control
n=1018 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=1408 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
Median Duration of Suctioning Among All Live Births
|
—
|
16.0 seconds
Interval 0.0 to 29.0
|
14.0 seconds
Interval 0.0 to 23.0
|
24.0 seconds
Interval 11.0 to 44.0
|
17.0 seconds
Interval 10.0 to 30.0
|
—
|
SECONDARY outcome
Timeframe: First hour after birthPopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=284 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=367 Participants
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).
|
Debriefing Control
n=218 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=210 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
Mean Duration of Suctioning Among Live Births Not Crying By 30 Seconds
|
—
|
33.6 seconds
Standard Deviation 53.1
|
24.7 seconds
Standard Deviation 28.9
|
52.0 seconds
Standard Deviation 63.2
|
38.0 seconds
Standard Deviation 42.1
|
—
|
SECONDARY outcome
Timeframe: First hour after birthPopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=284 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=367 Participants
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).
|
Debriefing Control
n=218 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=210 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
Median Duration of Suctioning Among Live Births Not Crying By 30 Seconds
|
—
|
25.0 seconds
Interval 8.0 to 42.0
|
20.0 seconds
Interval 0.0 to 31.0
|
35.0 seconds
Interval 19.0 to 66.0
|
25.0 seconds
Interval 14.0 to 46.0
|
—
|
SECONDARY outcome
Timeframe: First hour after birthPopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=284 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=367 Participants
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).
|
Debriefing Control
n=218 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=210 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
Proportion Suctioned For <30 Seconds Among Live Births Not Crying By 30 Seconds
|
—
|
0.613 proportion of neonates
|
0.722 proportion of neonates
|
0.44 proportion of neonates
|
0.571 proportion of neonates
|
—
|
SECONDARY outcome
Timeframe: First hour after birthPopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=12 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=47 Participants
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).
|
Debriefing Control
n=20 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=56 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
Mean Time to Bag Mask Ventilation (BMV) Among Live Births Not Crying By 30 Seconds Who Receive BMV
|
—
|
256.8 seconds
Standard Deviation 132.7
|
180.6 seconds
Standard Deviation 83.2
|
152.5 seconds
Standard Deviation 74.0
|
116.1 seconds
Standard Deviation 71.5
|
—
|
SECONDARY outcome
Timeframe: First hour after birthPopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=12 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=47 Participants
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).
|
Debriefing Control
n=20 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=56 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
Median Time to Bag Mask Ventilation (BMV) Among Live Births Not Crying By 30 Seconds Who Receive BMV
|
—
|
293.5 seconds
Interval 171.0 to 332.0
|
149.0 seconds
Interval 111.0 to 261.0
|
134.5 seconds
Interval 114.5 to 179.5
|
95.5 seconds
Interval 76.5 to 142.0
|
—
|
SECONDARY outcome
Timeframe: First hour after birthPopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=12 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=47 Participants
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).
|
Debriefing Control
n=20 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=56 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
Proportion Who Receive Bag Mask Ventilation (BMV) Within 1 Minute Among Live Births Not Crying By 30 Seconds Who Receive BMV
|
—
|
0.167 proportion of neonates
|
0 proportion of neonates
|
0 proportion of neonates
|
0.179 proportion of neonates
|
—
|
SECONDARY outcome
Timeframe: First hour after birthPopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=12 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=47 Participants
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).
|
Debriefing Control
n=20 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=56 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
Proportion Who Receive Bag Mask Ventilation (BMV) Within 2 Minutes Among Live Births Not Crying By 30 Seconds Who Receive BMV
|
—
|
0.25 proportion of neonates
|
0.298 proportion of neonates
|
0.25 proportion of neonates
|
0.625 proportion of neonates
|
—
|
SECONDARY outcome
Timeframe: First hour after birthPopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=126 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=143 Participants
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).
|
Debriefing Control
n=98 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=98 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
Proportion Who Receive Bag Mask Ventilation (BMV) Among Live Births Not Crying By 60 Seconds
|
—
|
0.079 proportion of neonates
|
0.266 proportion of neonates
|
0.194 proportion of neonates
|
0.571 proportion of neonates
|
—
|
SECONDARY outcome
Timeframe: First hour after birthPopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=747 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=950 Participants
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).
|
Debriefing Control
n=800 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=1198 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
Mean Duration of Suctioning Among Live Births Crying By 30 Seconds
|
—
|
17.4 seconds
Standard Deviation 29.0
|
12.2 seconds
Standard Deviation 13.5
|
29.2 seconds
Standard Deviation 27.2
|
20.6 seconds
Standard Deviation 15.3
|
—
|
SECONDARY outcome
Timeframe: First hour after birthPopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=747 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=950 Participants
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).
|
Debriefing Control
n=800 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=1198 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
Median Duration of Suctioning Among Live Births Crying By 30 Seconds
|
—
|
13.0 seconds
Interval 0.0 to 26.0
|
12.0 seconds
Interval 0.0 to 20.0
|
22.0 seconds
Interval 10.0 to 41.0
|
17.0 seconds
Interval 10.0 to 28.0
|
—
|
SECONDARY outcome
Timeframe: First hour after birthPopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=747 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=950 Participants
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).
|
Debriefing Control
n=800 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=1198 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
Proportion Suctioned Among Live Births Crying By 30 Seconds
|
—
|
0.667 proportion of neonates
|
0.568 proportion of neonates
|
0.96 proportion of neonates
|
0.957 proportion of neonates
|
—
|
SECONDARY outcome
Timeframe: First hour after birthPopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=3 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=81 Participants
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).
|
Debriefing Control
n=5 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=52 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
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
|
—
|
177.7 seconds
Standard Deviation 211.6
|
81.0 seconds
Standard Deviation 83.3
|
102.0 seconds
Standard Deviation 38.1
|
79.5 seconds
Standard Deviation 62.4
|
—
|
SECONDARY outcome
Timeframe: First hour after birthPopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=3 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=81 Participants
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).
|
Debriefing Control
n=5 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=52 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
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
|
—
|
59.0 seconds
Interval 52.0 to 422.0
|
48.0 seconds
Interval 39.0 to 89.0
|
79.0 seconds
Interval 75.0 to 134.0
|
51.5 seconds
Interval 42.0 to 109.5
|
—
|
SECONDARY outcome
Timeframe: First hour after birthPopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=265 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=353 Participants
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).
|
Debriefing Control
n=184 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=200 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
Mean Time to First Cry Among Live Births Not Crying By 30 Seconds
|
—
|
82.2 seconds
Standard Deviation 81.8
|
80.0 seconds
Standard Deviation 76.7
|
89.0 seconds
Standard Deviation 104.5
|
110.8 seconds
Standard Deviation 136.5
|
—
|
SECONDARY outcome
Timeframe: First hour after birthPopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=265 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=353 Participants
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).
|
Debriefing Control
n=184 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=200 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
Median Time to First Cry Among Live Births Not Crying By 30 Seconds
|
—
|
56.0 seconds
Interval 40.0 to 81.0
|
52.0 seconds
Interval 40.0 to 81.0
|
52.5 seconds
Interval 39.0 to 86.0
|
56.0 seconds
Interval 40.0 to 118.5
|
—
|
SECONDARY outcome
Timeframe: Between birth and 24 hours of agePopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=2076 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=3716 Participants
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).
|
Debriefing Control
n=2592 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=5573 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
Proportion of 24-Hour Newborn Mortality Among Live Births
Not transferred before 24 hours
|
—
|
0.002 proportion of neonates
|
0.0043 proportion of neonates
|
0.0054 proportion of neonates
|
0.0032 proportion of neonates
|
—
|
|
Proportion of 24-Hour Newborn Mortality Among Live Births
Transferred before 24 hours
|
—
|
0.167 proportion of neonates
|
0.118 proportion of neonates
|
0 proportion of neonates
|
0 proportion of neonates
|
—
|
SECONDARY outcome
Timeframe: Between birth and 24 hours of agePopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=2097 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=3724 Participants
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).
|
Debriefing Control
n=2619 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=5647 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
Proportion of Perinatal Mortality Among All Births
Not transferred before 24 hours
|
—
|
0.012 proportion of neonates
|
0.0065 proportion of neonates
|
0.0157 proportion of neonates
|
0.0163 proportion of neonates
|
—
|
|
Proportion of Perinatal Mortality Among All Births
Transferred before 24 hours
|
—
|
0.167 proportion of neonates
|
0.118 proportion of neonates
|
0 proportion of neonates
|
0 proportion of neonates
|
—
|
SECONDARY outcome
Timeframe: At birthPopulation: 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.
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.
Outcome measures
| Measure |
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.
|
Real-time Guidance Control
n=3 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Real-time Guidance Intervention
n=2 Participants
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).
|
Debriefing Control
n=3 Participants
Resuscitation per standard of care with use of heart rate meter called NeoBeat.
|
Debriefing Intervention
n=23 Participants
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).
|
Nurse Midwives
Midwives employed at the healthcare facility who participated in the study.
|
|---|---|---|---|---|---|---|
|
Proportion of Stillborn Misclassification Among Stillbirths Directly Observed at Birth
|
—
|
0 proportion of neonates
|
0 proportion of neonates
|
0 proportion of neonates
|
0 proportion of neonates
|
—
|
Adverse Events
Pilot
Real-time Guidance Control
Real-time Guidance Intervention
Debriefing Control
Debriefing Intervention
Nurse Midwives
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jackie Patterson, MD, MPH
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place