Investigating Fit and Satisfaction of the Prone Positioner

Description

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

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Study Overview

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Study Details

Study overview

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.

Investigating the Fit and Satisfaction of an Innovative Device - Prone to Excellence: A Tummy Time Device Prone Positioner for Infants With Medical Complexities Including Artificial Airways: A Design Pilot Study

Investigating Fit and Satisfaction of the Prone Positioner

Condition
Infant Development
Intervention / Treatment

-

Contacts and Locations

Kansas City

Children's Mercy Kansas City, Kansas City, Missouri, United States, 64108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

44 Weeks to 24 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Mercy Hospital Kansas City,

Brandi Dorton, DPT, NTMTC, PRINCIPAL_INVESTIGATOR, Children's Mercy Kansas City

Study Record Dates

2026-09