Interactive Resuscitation Application for Mothers About to Experience Premature Infant Resuscitation

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Stephanie Stewart
Study ID
NCT05243043
Status
Recruiting
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Conditions

  • Resuscitation

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Study Details

The purpose of this study is to design, develop, validate and pilot test an interactive Maternal Resuscitation Navigation Application (MARINA) for the purpose of providing information and guidance about the expected events that a premature infant will experience during initial resuscitation upon delivery. This information will be shared via computer app prior to the time that the mother would be in distress due to active labor. The application will be pilot tested for functionality, usability and feasibility of future use and research in clinical settings. Focused aspects of the application will include simulated video of the active delivery environment, explanation of each team member's role in resuscitation and specific activities involved in premature infant resuscitation. To assure the application addresses key information mothers would desire, the application will include content developed with input from a consulting group of mothers who have experienced premature infant resuscitation in the delivery room. Additionally, prior research by the research team will inform the build of this application. The application will have the ability for mothers to choose whether to view close up procedures (bag/mask positive pressure oxygen delivery, intubation, line placement, etc.). She may alternatively select to only view the broader view of the room while listening to the description of activities occurring at that time. The mother will be able to choose her level of interactivity depending on her comfort level. The application will go through multiple levels of testing throughout the development process. After an iterative process, when the research team finds the application acceptable, a small group of consulting parents and experienced clinicians will review the application for functionality (ease of use) and content validity. Aim 2: To pilot test the functionality, usability and feasibility of the interactive Maternal Resuscitation Navigation Application (MARINA) for future use and research in clinical settings to reduce maternal distress associated with premature infant resuscitation.

Key Dates

Start date
Aug 31, 2022
Status verified
Aug 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Control
    Mothers who experienced premature infant resuscitation in Labor and Delivery without the information provided by a computerized informational app.
  • Arm: Intervention (future)
    Mothers who experienced premature infant resuscitation in Labor and Delivery with the information provided ahead of time by the computerized informational application.

Primary Outcome Measure

Impact of Event Scale-Revised [ Time Frame: Beginning 24 hours after a mother experiences her child's resuscitation until 65 days post the resuscitation. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Stead Family Children's HospitalIowa CityIowa52242
Stephanie A Stewart, PhD
[email protected]
319-353-7999

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By research site
University of Iowa Stead Family Children's Hospital· Iowa City, IA

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