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NCT05963516
Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study)
NA trial testing LIVEBORN: A Mobile Health Application (app) for Newborn Resuscitation in Respiratory Depression Neonatal in 14,130 participants. Completed in 19 June 2025.
22 May 2025
Quick facts
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 14,130 |
| Start date | 23 August 2023 |
| Primary completion | 22 May 2025 |
| Estimated completion | 19 June 2025 |
| Sites | 4 locations across Democratic Republic of the Congo |
Drugs / interventions tested
- LIVEBORN: A Mobile Health Application (app) for Newborn Resuscitation
- NeoBeat: Heart Rate Meter for Newborn Resuscitation
Conditions studied
- Respiratory Depression Neonatal — all drugs for Respiratory Depression Neonatal →
Sponsor
University of North Carolina, Chapel Hill
Who can join
Eligibility, any sex, with Respiratory Depression Neonatal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05963516
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other recruiting trials for Respiratory Depression Neonatal
Currently open trials in the same condition.
- NCT07375667 — Dynamic Airway Resistance & ML: Guide Sputum Suction in Ventilated Patients · NA · recruiting
Other University of North Carolina, Chapel Hill trials
Trials by the same sponsor.
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- NCT07507370 — CARED : A Novel Rapid Treatment Paradigm for Depression · NA · not yet recruiting
- NCT07534254 — Piloting a Generative Artificial Intelligence Chatbot in a Mobile Weight Loss Program · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05963516 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
- Last refreshed: 13 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05963516.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing