Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05963516
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2023-07-17
Brief Title:
Bedside Improvement of Resuscitation Through mHealth Feedback BIRTH Study
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Bedside Improvement of Resuscitation Through mHealth Feedback BIRTH Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
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 ie 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 20 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 andor 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
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 20 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R33HD103058 | NIH | None | None |
| IGHID 12309 | OTHER | University of North Carolina at Chapel Hill | httpsreporternihgovquickSearchR33HD103058 |