Improving newborn resuscitation with mobile health feedback
Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study)
This study tests if a mobile app can help healthcare workers in Kinshasa improve their skills in resuscitating newborns by providing real-time guidance and feedback.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25150 (estimated) |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 4 sites (Kinshasa and 3 other locations) |
| Trial ID | NCT05963516 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a mobile health application called LIVEBORN in providing feedback during newborn resuscitation. It compares two methods of feedback: real-time guidance and debriefing, using a randomized cluster design across six health facilities in Kinshasa, Democratic Republic of the Congo. The study includes a pilot phase to establish training systems for nurse midwives and ensure consistent use of the application. The goal is to enhance the skills of healthcare providers in resuscitating newborns effectively.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns admitted to participating health facilities, regardless of their birth status, as well as nurse midwives caring for them.
Not a fit: Patients who may not benefit include those born before 28 weeks of gestation, outborn infants, or those with known congenital anomalies.
Why it matters
Potential benefit: If successful, this approach could significantly improve the outcomes of newborns experiencing respiratory depression during resuscitation.
How similar studies have performed: Other studies have shown promise in using mobile health applications for improving clinical practices, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kinshasa and 3 other locations
- Binza — Kinshasa, Congo, The Democratic Republic of the (Recruiting)
- Bondo — Kinshasa, Congo, The Democratic Republic of the (Recruiting)
- Kingasani — Kinshasa, Congo, The Democratic Republic of the (Recruiting)
- Saint Gabriel — Kinshasa, Congo, The Democratic Republic of the (Recruiting)
Study contacts
- Principal investigator: Jackie Patterson, MD, MPH — University of North Carolina, Chapel Hill
- Study coordinator: Jackie Patterson, MD, MPH
- Email: jackie_patterson@med.unc.edu
- Phone: 984-974-7855
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.