NCT06018064 · Children's Mercy Hospital Kansas City
Investigating Fit and Satisfaction of the Prone Positioner
What this study is about
The goal of this clinical trial is to learn about the use of the Prone Positioner in pediatric patients with tracheostomies (trachs).
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Kansas City, Missouri
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 5, 2025 · Source of record for eligibility and locations