Investigating Fit and Satisfaction of the Prone Positioner

December 1, 2025 updated by: Brandi Dorton, Children's Mercy Hospital Kansas City

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 place the infant in the prone positioner device. At no time will the baby be left alone or unsupported by staff. The study team will assess the physical fit, ease of getting the infant in and out of the device, and the patient's tolerance to being in the positioner.

Parents/guardians will be able to be present while the patient is in the device (if the parents are available and present at the time of fit testing) and immediately following the patient's removal from the device, the parents will be asked to complete a paper survey. The survey will ask for their perceptions of the device, initial reactions, and other qualitative data collected during the fit test. Healthcare providers who are not part of the study team will also be surveyed to obtain their thoughts/opinions on the device as well.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Brandi Dorton, DPT, NTMTC
  • Phone Number: 8162343380
  • Email: bbdorton@cmh.edu

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Kansas City
        • Contact:
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional Arm
Subjects who are placed in the Prone Positioner for evaluation
Device: Prone Positioner
An innovative device to allow for infants to be supported while in the prone position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fit and Size of Prone Positioner
Time Frame: 45 minutes
Evaluate the fit and size of the prone positioner prototype with infants with tracheostomies of varying ages/sizes
45 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental Satisfaction with Prone Positioner
Time Frame: Post patient use of positioner, survey to take a maximum of 10 minutes
Evaluate if the prone positioner appeals to parents' satisfaction and trust in its use (i.e., does the device fulfill the goal of allowing infants with trachs participate in tummy time?)
Post patient use of positioner, survey to take a maximum of 10 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Positioning Needs of Patients
Time Frame: Observed during the 45 min when patient is in Prone Positioner
Evaluate if the current prone positioner design improves positioning needs of patients who have tracheostomies and are ventilator dependent
Observed during the 45 min when patient is in Prone Positioner
Aesthetic and Usability Feedback of Prone Positioner
Time Frame: Post patient use of positioner, survey to take a maximum of 10 minutes
Gather aesthetic and usability feedback on the prone positioner from families, therapists, and nursing staff
Post patient use of positioner, survey to take a maximum of 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Brandi Dorton, DPT, NTMTC, Children's Mercy Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

August 25, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00002288

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data (IPD) elements will only be made available to the study team within Children's Mercy Kansas City. These IPD will be protected to greatest extent possible by the study team through the use of encrypted files and password protected sign-ons.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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