Status:
COMPLETED
Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study)
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Doris Duke Charitable Foundation
Conditions:
Respiratory Depression Neonatal
Eligibility:
All Genders
Phase:
NA
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 guid...
Detailed Description
Study Sites: the investigators will conduct this pre-post interventional trial in six health facilities in Kinshasa, Democratic Republic of the Congo (DRC). Pilot Phase: The purpose of the pilot ph...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2025
Estimated Enrollment :
14130 Patients enrolled
Trial Details
Trial ID
NCT05963516
Start Date
August 23 2023
End Date
June 19 2025
Last Update
August 13 2025
Active Locations (4)
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1
Binza
Kinshasa, Democratic Republic of the Congo
2
Bondo
Kinshasa, Democratic Republic of the Congo
3
Kingasani
Kinshasa, Democratic Republic of the Congo
4
Saint Gabriel
Kinshasa, Democratic Republic of the Congo