← Back to all trials
Completed
NCT05963516
Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study)
Conditions: Respiratory Depression Neonatal
Sex: All
Healthy volunteers: Yes
Phase: NA
Enrollment: 14679
Sponsor: University of North Carolina, Chapel Hill
Location: Binza Kinshasa
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 \
Source: ClinicalTrials.gov (NCT05963516). StuddyBuddy aggregates publicly available trial information.