Investigating Fit and Satisfaction of the Prone Positioner

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Children's Mercy Hospital Kansas City
Study ID
NCT06018064
Status
Recruiting
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Conditions

  • Infant Development

Eligibility Criteria

Sex
ALL
Age
44 Weeks - 24 Months
Healthy Volunteers
Not accepted

Interventions

  • Prone Positioner — DEVICE
    An innovative device to allow for infants to be supported while in the prone position

Study Details

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 Dates

Start date
Sep 21, 2023
Status verified
Dec 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Interventional Arm
    Subjects who are placed in the Prone Positioner for evaluation

Primary Outcome Measure

Fit and Size of Prone Positioner [ Time Frame: 45 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Mercy Kansas CityKansas CityMissouri64108
Brandi Dorton, DPT, NTMTC
[email protected]
Jennifer Marshall, MPH, RN
[email protected]
9132449566

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By research site
Children's Mercy Kansas City· Kansas City, MO

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