Recruiting

Observational Study

Sponsor:

Children's Mercy Hospital Kansas City

Code:

NCT06018064

Conditions

Infant Development

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

Prone Positioner

Study Details

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 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

Study ID

NCT06018064

Start date

Sep 21, 2023

Status verified date

Dec, 2025

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Interventional Arm

Subjects who are placed in the Prone Positioner for evaluation

Interventions

Prone Positioner

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Brandi Dorton, DPT, NTMTC

8162343380bbdorton@cmh.edu

Jennifer A Marshall, MPH, RN

jamarshall@cmh.edu

Locations

Children's Mercy Kansas City

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Brandi Dorton, DPT, NTMTC

bbdorton@cmh.edu

Jennifer Marshall, MPH, RN

9132449566jamarshall@cmh.edu

More Information

Sponsor

Children's Mercy Hospital Kansas City

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Mercy Hospital Kansas City on 2025-12-05.