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Life sciences · Interventional Study
ClinicalTrials.gov · September 28, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT05963516). This is a study registration, not published results. Lead sponsor: University of North Carolina, Chapel Hill. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 14679 participants (ACTUAL). Conditions: Respiratory Depression Neonatal. Interventions: OTHER: LIVEBORN: A Mobile Health Application (app) for Newborn Resuscitation; DEVICE: NeoBeat: Heart Rate Meter for Newborn Resuscitation. Primary outcome measures: Mean Duration of Suctioning Among All Live Births , First hour after birth; Median Duration of Suctioning Among All Live Births , First hour after birth. Brief 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.