Investigating Fit and Satisfaction of the Prone Positioner
Recruiting now · Not applicable
Conditions studied: Infant Development
In brief
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.
Key facts
- Study ID
- NCT06018064
- Run by
- Children's Mercy Hospital Kansas City
- People needed
- 30
- Starts
- 2023-09-21
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2025-12-05
Who can join
Age: 1 and older, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Children's Mercy Kansas City — Kansas City, Missouri, United States (enrolling)
Full record on ClinicalTrials.gov
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