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Investigating Fit and Satisfaction of the Prone Positioner

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Sep 2025 to Sep 2027
    • Study completion date: Sep 2026 to Sep 2028
    v6
  2. Re-verified, no change to tracked fieldsv5
  3. Eligibility criteria shortened, about 1 wordv4
  4. Eligibility criteria expanded, about 19 wordsv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2023 to Sep 21, 2023
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06018064
Lead Sponsor Children's Mercy Hospital Kansas City
Conditions
(from sponsor)		 Infant Development
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov