Recruiting

Observational Study

Sponsor:

Stephanie Stewart

Code:

NCT05243043

Conditions

Resuscitation

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT05243043

Start date

Aug 31, 2022

Status verified date

Aug, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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. ]
  • Perinatal Post traumatic Stress Disorder Questionaire-II [ Time Frame: Beginning 24 hours after a mother experiences her child's resuscitation until 65 days post the resuscitation. ]

Central Contacts and Locations

Central contacts

Locations

University of Iowa Stead Family Children's Hospital

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

More Information

Sponsor

Stephanie Stewart

Last update posted

Aug 12, 2025

Last verified

Aug, 2025

Keywords

  • Mothers' experience
  • Premature infant resuscitation
  • Post traumatic stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stephanie Stewart on 2025-08-12.