Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study)

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

Interventions

OTHER

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

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.

DEVICE

NeoBeat: Heart Rate Meter for Newborn Resuscitation

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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Doris Duke Charitable Foundation

  collaborator OTHER

• Laerdal Global Health

  collaborator OTHER

• Kinshasa School of Public Health

  collaborator OTHER

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Jackie Patterson, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-08-23

Primary Completion

2025-05-22

Completion

2025-06-19

Countries

• Democratic Republic of the Congo

Study Locations