Status:
RECRUITING
Investigating Fit and Satisfaction of the Prone Positioner
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Infant Development
Eligibility:
All Genders
44-24 years
Phase:
NA
Brief Summary
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 a...
Detailed Description
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 pl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06018064
Start Date
September 21 2023
End Date
September 1 2028
Last Update
December 5 2025
Active Locations (1)
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1
Children's Mercy Kansas City
Kansas City, Missouri, United States, 64108