N/A
N=441
Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study)
Respiratory Depression Neonatal
Bottom Line
View on ClinicalTrials.gov: NCT05963516 ↗Enrolled (actual)
441
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Mean Duration of Suctioning Among All Live Births — 21.9; 15.7; 34.1; 23.2 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LIVEBORN: A Mobile Health Application (app) for Newborn Resuscitation (Other); NeoBeat: Heart Rate Meter for Newborn Resuscitation (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Duration of Suctioning Among All Live Births |
21.9; 15.7; 34.1; 23.2 | — |
| PRIMARY Median Duration of Suctioning Among All Live Births |
16.0; 14.0; 24.0; 17.0 | — |
| SECONDARY Mean Duration of Suctioning Among Live Births Not Crying By 30 Seconds |
33.6; 24.7; 52.0; 38.0 | — |
| SECONDARY Median Duration of Suctioning Among Live Births Not Crying By 30 Seconds |
25.0; 20.0; 35.0; 25.0 | — |
| SECONDARY Proportion Suctioned For <30 Seconds Among Live Births Not Crying By 30 Seconds |
0.613; 0.722; 0.44; 0.571 | — |
| SECONDARY Mean Time to Bag Mask Ventilation (BMV) Among Live Births Not Crying By 30 Seconds Who Receive BMV |
256.8; 180.6; 152.5; 116.1 | — |
| SECONDARY Median Time to Bag Mask Ventilation (BMV) Among Live Births Not Crying By 30 Seconds Who Receive BMV |
293.5; 149.0; 134.5; 95.5 | — |
| SECONDARY Proportion Who Receive Bag Mask Ventilation (BMV) Within 1 Minute Among Live Births Not Crying By 30 Seconds Who Receive BMV |
0.167; 0; 0; 0.179 | — |
| SECONDARY Proportion Who Receive Bag Mask Ventilation (BMV) Within 2 Minutes Among Live Births Not Crying By 30 Seconds Who Receive BMV |
0.25; 0.298; 0.25; 0.625 | — |
| SECONDARY Proportion Who Receive Bag Mask Ventilation (BMV) Among Live Births Not Crying By 60 Seconds |
0.079; 0.266; 0.194; 0.571 | — |
| SECONDARY Mean Duration of Suctioning Among Live Births Crying By 30 Seconds |
17.4; 12.2; 29.2; 20.6 | — |
| SECONDARY Median Duration of Suctioning Among Live Births Crying By 30 Seconds |
13.0; 12.0; 22.0; 17.0 | — |
| SECONDARY Proportion Suctioned Among Live Births Crying By 30 Seconds |
0.667; 0.568; 0.96; 0.957 | — |
| 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 |
177.7; 81.0; 102.0; 79.5 | — |
| 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 |
59.0; 48.0; 79.0; 51.5 | — |
| SECONDARY Mean Time to First Cry Among Live Births Not Crying By 30 Seconds |
82.2; 80.0; 89.0; 110.8 | — |
| SECONDARY Median Time to First Cry Among Live Births Not Crying By 30 Seconds |
56.0; 52.0; 52.5; 56.0 | — |
| SECONDARY Proportion of 24-Hour Newborn Mortality Among Live Births |
0.002; 0.0043; 0.0054; 0.0032; 0.167; 0.118 | — |
| SECONDARY Proportion of Perinatal Mortality Among All Births |
0.012; 0.0065; 0.0157; 0.0163; 0.167; 0.118 | — |
| SECONDARY Proportion of Stillborn Misclassification Among Stillbirths Directly Observed at Birth |
0; 0; 0; 0 | — |
Summary
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.
Eligibility Criteria
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.
Exclusion criteria
- Less than 28 weeks completed gestation (or if gestational age is unknown, birth weight <1,000 grams),
- outborn,
- 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
Data sourced from ClinicalTrials.gov (NCT05963516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.