Clinical trial NCT05963516: Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study)
Official title: Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Depression Neonatal
Keywords: Resuscitation
Helping Babies Breathe
Debriefing
Real-Time Guidance
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Doris Duke Charitable Foundation
name: Laerdal Global Health
name: Kinshasa School of Public Health
First posted: 2023-07-27
Enrollment: 25150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Study Sites:

the investigators will conduct this pre-post interventional trial in six health facilities in Kinshasa, Democratic Republic of the Congo (DRC).

Pilot Phase:

The purpose of the pilot phase is to establish systems to ensure 1) implementation of recommended training and simulation practice and 2) consistent use of LIVEBORN for observations. The pilot phase will last approximately two months. Any facilities deemed facile with LIVEBORN will be exempted from the pilot phase.

Establishment of a System for Implementation of Recommended Training and Simulation Practice: During the pilot phase, the investigators will work with each facility to ensure a system for implementation of recommended resuscitation training and low-dose high-frequency (LDHF) practice of bag-mask ventilation (BMV).

Basic Resuscitation Training: The investigators will train all nurse midwives in basic resuscitation using Helping Babies Breathe (HBB) 2.0 materials adapted to include the use of NeoBeat, a battery-operated heart rate (HR) meter. In addition to reviewing the evidence-based HBB resuscitation algorithm, research staff will orient nurse midwives to use of NeoBeat. The training will also include how to use HR to accurately distinguish liveborn from stillborn infants. The investigators will recommend that nurse midwives use NeoBeat for high-risk pregnancies and newborns not crying by 30 seconds.

Establishment of a System for Consistent Use of LIVEBORN for Observations: During the pilot phase, the investigators will work with each facility to ensure a system for consistent use of LIVEBORN for observations. This system will include placement of NeoBeat on newborns requiring resuscitation.

The investigators will use an established participatory research methodology called trials of improved practices (TIPs) which the investigators successfully used in the R21 phase of this work to design a strategy for consistent use of LIVEBORN for observations. At each facility, the investigators will conduct a strategy development session with facility leadership such as the head nurse midwife to develop an initial strategy for implementation of LIVEBORN. Each health facility will implement the locally-developed initial strategy in a small-scale test for approximately three weeks. Throughout the small-scale test, the investigators will rapidly analyze data and identify barriers to implementation of the strategy as well as potential solutions. The investigators will refine the strategy in additional cycles of TIPs (strategy development, small-scale testing, rapid analysis) until the investigators have identified a feasible strategy to move into the control phase.

Control Phase:

The purpose of the control phase is to gather detailed, prospective data on resuscitation care and newborn outcomes while implementing recommended practice. During a six-month control phase, midwives will implement HBB in their clinical practice with LDHF simulation practice of BMV. LDHF practice will occur at regular intervals per the system set up during the pilot phase. Nurse midwives will place NeoBeat on newborns that they anticipate resuscitating.

Data Collection: Research staff will conduct medical record abstraction to document clinical data for each eligible newborn including such elements as maternal parity and age, birth date and time, infant gestational age, birth weight, mode of delivery, stillborn or liveborn, alive or dead at discharge (including date of death). As in the pilot phase, trained observers (research staff, midwives, and other designated observers per the strategy developed in the pilot phase) will conduct observations of resuscitations for a convenience sample of births using the LIVEBORN app. If NeoBeat is placed on the newborn, the investigators will collect ECG data.

Preparatory Activities for the Intervention Phase: While in the control phase, the investigators will randomize facilities to either real-time guidance or debriefing with LIVEBORN in preparation for the intervention phase. Prior to implementation of the intervention and towards the end of the control phase, research staff will prepare nurse midwives to implement LIVEBORN feedback per their cluster randomized assignment using simulation.

Intervention Phase:

The purpose of the intervention phase is to gather prospective data on resuscitation care and newborn outcomes during implementation of LIVEBORN feedback. During this 12-month phase, nurse midwives will implement LIVEBORN feedback per their cluster-randomized assignment to either real-time guidance or debriefing. Additionally, nurse midwives will continue all study procedures from the control phase, including implementation of HBB with LDHF practice, use of NeoBeat on newborns requiring resuscitation, and observation of births using LIVEBORN.

Implementation of LIVEBORN Feedback: At facilities randomized to real-time guidance, midwives will be supported by audio-visual feedback from LIVEBORN during the convenience sample of resuscitations observed with LIVEBORN. At facilities randomized to debriefing, midwives will debrief with LIVEBORN for at least 50% of the convenience sample of resuscitations observed with LIVEBORN that involved a newborn not crying by 60 seconds after birth and/or the receipt of BMV.

Data Collection: As in the control phase, research staff will conduct medical record abstraction to document clinical data for each enrolled. As in the pilot and control phases, trained observers (research staff, midwives, and other designated observers per the strategy developed in the pilot phase) will conduct observations of resuscitations for a convenience sample of births using the LIVEBORN app. If NeoBeat is placed on the newborn, the investigators will collect ECG data. At the end of the intervention, five midwives \& the head nurse midwife from each facility will complete surveys consisting of 4-item quantitative scales to evaluate feasibility and acceptability using the Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM).

Eligibility 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

Primary outcomes:
measure: Mean Duration of Suctioning Among Newborns Not Crying By 30 Seconds
timeFrame: First hour after birth
measure: Median Duration of Suctioning Among Newborns Not Crying By 30 Seconds
timeFrame: First hour after birth
Secondary outcomes:
measure: Suctioned For <30 Seconds Among Newborns Not Crying By 30 Seconds
timeFrame: First hour after birth
measure: Mean Time to Bag Mask Ventilation
timeFrame: First hour after birth
measure: Median Time to Bag Mask Ventilation
timeFrame: First hour after birth
measure: Proportion of Newborns Who Receive BMV within the Golden Minute Among All Livebirths Not Crying by 30 Seconds Who Receive BMV
timeFrame: First hour after birth
measure: Proportion of Livebirths Not Crying by 60 Seconds Who Receive BMV
timeFrame: First hour after birth
measure: Mean Time from Birth to Heart Rate ≥100 Beats Per Minute
timeFrame: First hour after birth
measure: Median Time from Birth to Heart Rate ≥100 Beats Per Minute
timeFrame: First hour after birth
measure: Mean Time to First Cry among Livebirths Who Have Not Cried by 30 Seconds
timeFrame: First hour after birth
measure: Median Time to First Cry among Livebirths Who Have Not Cried by 30 Seconds
timeFrame: First hour after birth
measure: Mean Duration of Suctioning Among Newborns Who Cry By 30 Seconds
timeFrame: First hour after birth
measure: Median Duration of Suctioning Among Newborns Who Cry By 30 Seconds
timeFrame: First hour after birth
measure: Proportion of Livebirths Crying by 30 Seconds Who Are Suctioned for Less than 30 Seconds
timeFrame: First hour after birth
measure: Proportion of Livebirths Who Have Died by 24 Hours After Birth
timeFrame: Between birth and 24 hours of age
measure: Proportion of Births Resulting in a Fresh Stillbirth or Neonatal Death in the First 24 hours
timeFrame: Between birth and 24 hours of age
measure: Proportion of Stillbirths That Are Misclassified
timeFrame: At birth
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Binza
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Bondo
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Kingasani
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Saint Gabriel
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jackie Patterson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: