Investigating Fit and Satisfaction of the Prone Positioner

Study Overview
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Brief Summary
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The goal of this clinical trial is to learn about the use of the Prone Positioner in pediatric patients with tracheostomies (trachs). The main question[s] it aims to answer are: What is the fit and satisfaction of the device? Does the device fulfill the goal of allowing infants with trachs participate in tummy time What aesthetic feedback will the study team receive on the prone positioner from families, therapists, and nursing staff. Participants will be placed in the Prone Positioner, they will be monitored for their comfort/satisfaction with use, and how well they are able to be receive ventilation while in the device. Parents of these infants, as well as healthcare providers, will be surveyed on thoughts/suggestions for the Prone Positioner.

Detailed Description
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A trained member of this study staff will be always present in the patient room during the fit test. For the fit test, a therapist from the study team will takes measurements of the infant and then place the infant in the prone positioner device. At no time will the baby be left alone or unsupported by staff. The study team will assess the physical fit, ease of getting the infant in and out of the device, and the patient's tolerance to being in the positioner. Parents/guardians will be able to be present while the patient is in the device (if the parents are available and present at the time of fit testing) and immediately following the patient's removal from the device, the parents will be asked to complete a paper survey. The survey will ask for their perceptions of the device, initial reactions, and other qualitative data collected during the fit test. Healthcare providers who are not part of the study team will also be surveyed to obtain their thoughts/opinions on the device as well.

Official Title
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Investigating the Fit and Satisfaction of an Innovative Device - Prone to Excellence: A Tummy Time Device Prone Positioner for Infants With Medical Complexities Including Artificial Airways: A Design Pilot Study

Conditions
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Infant Development

Intervention / Treatment
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* Device: Prone Positioner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatient infants located on the Pediatric Intensive Care Unit (PICU) or (Neonatal Intensive Care Unit (NICU) with tracheostomies between the ages of >44 weeks gestational age to 18 months of age with various size/weights of infants. Any race/ethnicity English speaker Males and females Caregivers Children's Mercy (CM) Occupational Therapists (OTs), Physical Therapists (PTs), Speech Therapists (STs) who have not seen the new prone positioner device. Exclusion Criteria: Infants > 18 months of age Infants medically unstable as determined by attending physician in the PICU/NICU Infants with recent cardiac or abdominal surgery who have precautions or complications related to their surgery. Infants with weightbearing restrictions/fractures in their upper extremities. Non-English speakers

Ages Eligible for Study
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Minimum Age: 44 Weeks
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Infants between the ages >44 weeks gestational age to 18 months of age with complex medical conditions, particularly those with tracheostomies
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Arm<br>Subjects who are placed in the Prone Positioner for evaluation | Device: Prone Positioner<br>* An innovative device to allow for infants to be supported while in the prone position<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fit and Size of Prone Positioner | Evaluate the fit and size of the prone positioner prototype with infants with tracheostomies of varying ages/sizes | 45 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental Satisfaction with Prone Positioner | Evaluate if the prone positioner appeals to parents' satisfaction and trust in its use (i.e., does the device fulfill the goal of allowing infants with trachs participate in tummy time?) | Post patient use of positioner, survey to take a maximum of 10 minutes |