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Investigating Fit and Satisfaction of the Prone Positioner

NCT06018064 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-05

No results posted yet for this study

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 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.

Conditions

  • Infant Development

Interventions

DEVICE

Prone Positioner

An innovative device to allow for infants to be supported while in the prone position

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Brandi Dorton, DPT, NTMTC · Children's Mercy Kansas City

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
44 Weeks
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-21
Primary Completion
2027-09-30
Completion
2028-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06018064 on ClinicalTrials.gov