Evaluating the Fit and Satisfaction of a Device for Infants with Tracheostomies
Official title: 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
Run by Children's Mercy Hospital Kansas City · NCT06018064 · Data updated 2026-11-12
This study is testing a new device for infants with tracheostomies to see if it fits well and makes tummy time more comfortable and enjoyable for both the babies and their caregivers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 44 Weeks to 24 Months |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Children's Mercy Hospital Kansas City Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Status | Recruiting |
| Started | September 21, 2023 |
| Main results expected | September 2027 |
| Study ends | September 2028 |
| Registry record updated | December 5, 2025 |
| Trial ID | NCT06018064 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include infants aged over 44 weeks gestational age to 24 months with tracheostomies who are currently hospitalized in the PICU or NICU.
✕Probably not a fit
Patients who are medically unstable or over 24 months of age will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of a Prone Positioner for infants with tracheostomies, focusing on its fit, comfort, and satisfaction during tummy time. Participants will be monitored while using the device, and their parents and healthcare providers will provide feedback through surveys. The study aims to assess how well the device allows for ventilation and the overall experience of both infants and caregivers. The research team will ensure that trained staff are present at all times to support the infants during the assessment.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life for infants with tracheostomies by improving their ability to engage in tummy time safely.
How similar studies have gone: While similar studies on positioning devices for infants exist, this specific approach to evaluating the Prone Positioner is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Children's Mercy Kansas City
Kansas City, Missouri, United States Recruiting
Study contacts
- Principal investigator: Brandi Dorton, DPT, NTMTC — Children's Mercy Kansas City
- Study coordinator: Brandi Dorton, DPT, NTMTC
- Email: bbdorton@cmh.edu
- Phone: 8162343380
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.