Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study) (NCT05963516) | Clinical Trial Compass
CompletedNot Applicable
Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study)
Democratic Republic of the Congo14,680 participantsStarted 2023-08-23
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Duration of Suctioning Among All Live Births
Timeframe: First hour after birth
2
Median Duration of Suctioning Among All Live Births