NCT06018064 Investigating Fit and Satisfaction of the Prone Positioner
| NCT ID | NCT06018064 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Mercy Hospital Kansas City |
| Condition | Infant Development |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-09-21 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-09-21 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Brandi Dorton, DPT, NTMTC
PRINCIPAL INVESTIGATOR
Children's Mercy Kansas City
Frequently Asked Questions
Who can join the NCT06018064 clinical trial?
This trial is open to participants of all sexes, aged 44 Weeks or older, up to 24 Months, studying Infant Development. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06018064 currently recruiting?
Yes, NCT06018064 is actively recruiting participants. Contact the research team at bbdorton@cmh.edu for enrollment information.
Where is the NCT06018064 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT06018064 clinical trial?
NCT06018064 is sponsored by Children's Mercy Hospital Kansas City. The principal investigator is Brandi Dorton, DPT, NTMTC at Children's Mercy Kansas City. The trial plans to enroll 30 participants.