Interactive Resuscitation Application for Mothers About to Experience Premature Infant Resuscitation
ConditionResuscitation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorStephanie Stewart
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
control group: Infant death, mothers who required general anesthesia at the time of delivery, active investigation by Department of Human Services, prisoners, twin gestation
Trial 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.
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 2 trial groupsGroup A: Control
Group B: Intervention (future)
Trial outcomes
Primary outcomes
1
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.
Time frame
Beginning 24 hours after a mother experiences her child's resuscitation until 65 days post the resuscitation.2
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.
Time frame
Beginning 24 hours after a mother experiences her child's resuscitation until 65 days post the resuscitation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stephanie Stewart
Lead sponsor
University of Iowa
Sponsor institution
Source ClinicalTrials.gov