Investigating the Prone Positioner for Infants with Tracheostomies

This study is looking at a new device called the Prone Positioner. This device helps infants with tracheostomies (breathing tubes in their windpipe) lie on their stomachs for "tummy time." Researchers want to see how well the Prone Positioner fits different infants and if families, nurses, and therapists are happy with it. They also want to know if the device helps infants with tracheostomies comfortably participate in tummy time and how well they can breathe while using it. The study will involve about 30 infants, aged 44 weeks (gestational age) to 24 months, who are in the PICU (Pediatric Intensive Care Unit), NICU (Neonatal Intensive Care Unit), or Vent clinic at Children's Mercy.

Study design
This is an interventional study involving about 30 participants. It is not specified if the study is randomized or blinded.
What's involved
A trained staff member will be present while your infant is placed in the Prone Positioner for a fit test, which lasts about 45 minutes. You and healthcare providers will complete surveys about the device.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for fit and size is measured at 45 minutes, suggesting a short follow-up period.

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NCT06018064

Investigating Fit and Satisfaction of the Prone Positioner

Recruiting
NAAges 44–24InterventionalTreatment
Children's Mercy Hospital Kansas City
~30 participants
Updated 2025-12-05 on ClinicalTrials.gov
What's tested:Prone Positioner

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fit and Size of Prone Positioner
Measured over 45 minutes
Infant Development
1 sites across 1 states
Missouri1
  • Brandi Dorton, DPT, NTMTC · PRINCIPAL_INVESTIGATOR · Children's Mercy Kansas City

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Eligibility criteria

Inclusion

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

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
  • Fit and Size of Prone Positioner45 minutes

    Evaluate the fit and size of the prone positioner prototype with infants with tracheostomies of varying ages/sizes