Interactive Resuscitation Application for Mothers About to Experience Premature Infant Resuscitation

NCT05243043 | Recruiting

• 1 other identifier: 202103564
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Resuscitation

Keywords

Mothers' experience; Premature infant resuscitation; Post traumatic stress

Outcome Measures

Primary Outcomes (2)

• Impact of Event Scale-Revised

  Impact of Event Scale - Revised (IES-R) is a tool that measures a participants risk for posttraumatic stress after experiencing an event. The IES-R consists of twenty two question items with a five point Likert scale ranging in response from zero to four, zero denotes low stress and four denotes high stress. The range of total scores is 0-88 with higher scores interpreted as a more stressful impact due to a traumatic event. A score of 24 has been determined to indicate a level of posttraumatic stress high enough for clinical concern.

  Beginning 24 hours after a mother experiences her child's resuscitation until 65 days post the resuscitation.

• Perinatal Post traumatic Stress Disorder Questionaire-II

  Perinatal Post traumatic Stress Disorder Questionaire-II (PPQ-II) is a 14-item tool measure assessing post-traumatic symptoms related to the childbirth experience, including intrusiveness or re-experiencing, avoidance behaviors and hyperarousal or numbing of responsiveness. The PPQ-II also contains one item pertaining to feelings of guilt. Response options include a five-point likert scale (scored 0 to 4). Mothers were instructed to provide responses that reflected their experience. The total possible score on the modified PPQ-II ranges from 0 to 56 with a higher score indicating a higher level of maternal distress.

  Beginning 24 hours after a mother experiences her child's resuscitation until 65 days post the resuscitation.

Study Arms (2)

Control

Mothers who experienced premature infant resuscitation in Labor and Delivery without the information provided by a computerized informational app.

Intervention (future)

Mothers who experienced premature infant resuscitation in Labor and Delivery with the information provided ahead of time by the computerized informational application.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Control group: 20 mother/infant dyads not exposed to MARINA prior to delivery, but experienced resuscitation of a premature infant. A convenience sample of mothers whose newborn premature infants were delivered at UIHC between 24 and 32 weeks gestation. Intervention group: A convenience sample of 20 women who are expected to deliver a premature infant between 24 and 32 weeks gestation, as well as their premature infant born post intervention.

You may qualify if:

• Control group: English-speaking mothers, age 18 or older, delivered a premature infant at UIHC between 24- and 32-weeks and their infant born during this most recent gestation.

You may not qualify if:

• control group: Infant death, mothers who required general anesthesia at the time of delivery, active investigation by Department of Human Services, prisoners, twin gestation

Sponsors & Collaborators

• Stephanie Stewart: lead

Study Sites (1)

University of Iowa Stead Family Children's Hospital

Iowa City, Iowa, 52242, United States

RECRUITING

Study Officials

• Stephanie Stewart, PhD

  University of Iowa Stead Family Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Stewart, PhD

CONTACT

3193537999; stephanie-stewart@uiowa.edu

Timothy Elgin, MD

CONTACT

319-356-1671; timothy-elgin@uiowa.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Director, Nursing

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 16, 2022
• Study Start: August 31, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

US (1)