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Investigating Fit and Satisfaction of the Prone Positioner

RecruitingNAAges 44 Weeks - 24 MonthsAllChildren's Mercy Hospital Kansas City
NCT06018064 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Inpatient infants located on the Pediatric Intensive Care Unit (PICU) or (Neonatal Intensive Care Unit (NICU) or being seen in the Vent clinic at Children's Mercy with tracheostomies between the ages of \>44 weeks gestational age to 24 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 \> 24 months of age * Infants medically unstable as determined by attending physician in the PICU/NICU or Vent Clinic * 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 \* Wards of the state
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What it tests

  • Prone Positioner
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Where

1 site
Children's Mercy Kansas City
Kansas City, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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