Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study)

NCT05963516 | Completed

• 3 other identifiers: 23-0267R33HD103058IGHID 12309
• Study Type: interventional
• Target: 14,130
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Respiratory Depression Neonatal

Keywords

Resuscitation; Helping Babies Breathe; Debriefing; Real-Time Guidance

Outcome Measures

Primary Outcomes (2)

• Mean Duration of Suctioning Among Newborns Not Crying By 30 Seconds

  The investigators will measure duration of suctioning as a continuous variable among liveborn neonates who are not crying by 30 seconds. This variable will be collected via direct observation using the Liveborn application.

  First hour after birth

• Median Duration of Suctioning Among Newborns Not Crying By 30 Seconds

  The investigators will measure duration of suctioning as a continuous variable among liveborn neonates who are not crying by 30 seconds. This variable will be collected via direct observation using the Liveborn application.

  First hour after birth

Secondary Outcomes (15)

• Suctioned For <30 Seconds Among Newborns Not Crying By 30 Seconds

  First hour after birth

• Mean Time to Bag Mask Ventilation

  First hour after birth

• Median Time to Bag Mask Ventilation

  First hour after birth

• Proportion of Newborns Who Receive BMV within the Golden Minute Among All Livebirths Not Crying by 30 Seconds Who Receive BMV

  First hour after birth

• Proportion of Livebirths Not Crying by 60 Seconds Who Receive BMV

  First hour after birth

Study Arms (2)

Real-time Guidance

ACTIVE COMPARATOR

The LIVEBORN app will provide audio-visual guidance to the birth attendant during a resuscitation based on the data inputted by an observer as well as heart rate data from NeoBeat (if used).

Other: LIVEBORN: A Mobile Health Application (app) for Newborn Resuscitation; Device: NeoBeat: Heart Rate Meter for Newborn Resuscitation

Debriefing

ACTIVE COMPARATOR

The LIVEBORN app will support birth attendants in debriefing following a resuscitation based on the data inputted by an observer as well as heart rate data from NeoBeat (if used).

Other: LIVEBORN: A Mobile Health Application (app) for Newborn Resuscitation; Device: NeoBeat: Heart Rate Meter for Newborn Resuscitation

Interventions

LIVEBORN: A Mobile Health Application (app) for Newborn Resuscitation OTHER

LIVEBORN is a mobile health application designed to help providers learn from their clinical practice during newborn resuscitation through real-time guidance and debriefing. Using LIVEBORN, an observer can document events during a resuscitation such as the actions of the provider and when the baby cries. A battery-operated heart rate meter, NeoBeat, measures and sends the newborn's heart rate to the LIVEBORN app via Bluetooth. LIVEBORN integrates data from the observer and NeoBeat to provide audio-visual real-time guidance to the provider during a resuscitation. Following the resuscitation, providers can also debrief using LIVEBORN. The app operates on the Android system and is functional off-line, except for the need for an internet connection to upload data to the cloud for research.

Debriefing; Real-time Guidance

NeoBeat: Heart Rate Meter for Newborn Resuscitation DEVICE

NeoBeat is a low-cost device for the measurement of newborn heart rate (HR) that was developed by Laerdal Global Health for use in low-resource settings. It is applied by placing the device around the torso of the newborn. It detects HR accurately, quickly (\<5 sec), is reusable and can be easily disinfected. NeoBeat's dry electrodes detect HR which is digitally displayed and recorded. It uses an impedance system to sense skin contact and motion detection to validate signal quality. It does not require the use of buttons, adhesive, gel or cables and has no disposable parts. A single birth attendant can apply NeoBeat in 2-3 seconds.

Debriefing; Real-time Guidance

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All in-born neonates, either liveborn or intrapartum (i.e., fresh) stillborn, regardless of multiple gestation or maternal complication.

You may not qualify if:

• 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:
• 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.
• Unwillingness to consent

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Doris Duke Charitable Foundation: collaborator
• Laerdal Global Health: collaborator
• Kinshasa School of Public Health: collaborator

Study Sites (4)

Binza

Kinshasa, Democratic Republic of the Congo

Location

Bondo

Kinshasa, Democratic Republic of the Congo

Location

Kingasani

Kinshasa, Democratic Republic of the Congo

Location

Saint Gabriel

Kinshasa, Democratic Republic of the Congo

Location

MeSH Terms

Interventions

Amyloid

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Jackie Patterson, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 27, 2023
• Study Start: August 23, 2023
• Primary Completion: May 22, 2025
• Study Completion: June 19, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made indefinitely available no later than the acceptance for publication of the main findings from the final dataset.
• Access Criteria: In accordance with the selected public website criteria.

Locations

DE (4)