Children's Mercy Kansas City
Kansas City, Missouri, 64108, United States
Location status: Recruiting
Location contact
Brandi Dorton, DPT, NTMTC
CONTACT
Jennifer Marshall, MPH, RN
CONTACT
NCT Number: NCT06018064
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.
Interested in participating?
Request Info44 week–24 month
All sexes
Interventional
Not applicable
Kansas City, Missouri, 64108, United States
Location status: Recruiting
Brandi Dorton, DPT, NTMTC
CONTACT
Jennifer Marshall, MPH, RN
CONTACT
A trained member of this study staff will be always present in the patient room during the fit test. For the fit test, a therapist from the study team will takes measurements of the infant and then place the infant in the prone positioner device. At no time will the baby be left alone or unsupported by staff. The study team will assess the physical fit, ease of getting the infant in and out of the device, and the patient's tolerance to being in the positioner.
Parents/guardians will be able to be present while the patient is in the device (if the parents are available and present at the time of fit testing) and immediately following the patient's removal from the device, the parents will be asked to complete a paper survey. The survey will ask for their perceptions of the device, initial reactions, and other qualitative data collected during the fit test. Healthcare providers who are not part of the study team will also be surveyed to obtain their thoughts/opinions on the device as well.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An innovative device to allow for infants to be supported while in the prone position
Time frame: 45 minutes
Evaluate the fit and size of the prone positioner prototype with infants with tracheostomies of varying ages/sizes
Time frame: Post patient use of positioner, survey to take a maximum of 10 minutes
Evaluate if the prone positioner appeals to parents' satisfaction and trust in its use (i.e., does the device fulfill the goal of allowing infants with trachs participate in tummy time?)
Time frame: Observed during the 45 min when patient is in Prone Positioner
Evaluate if the current prone positioner design improves positioning needs of patients who have tracheostomies and are ventilator dependent
Time frame: Post patient use of positioner, survey to take a maximum of 10 minutes
Gather aesthetic and usability feedback on the prone positioner from families, therapists, and nursing staff
Contact information is provided by the study sponsor or research team.
Brandi Dorton, DPT, NTMTC
CONTACT
Jennifer A Marshall, MPH, RN
CONTACT
Children's Mercy Hospital Kansas City
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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