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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Arm | Experimental | Subjects who are placed in the Prone Positioner for evaluation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prone Positioner | Device | An innovative device to allow for infants to be supported while in the prone position |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fit and Size of Prone Positioner | Evaluate the fit and size of the prone positioner prototype with infants with tracheostomies of varying ages/sizes | 45 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Parental Satisfaction with Prone Positioner | 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?) | Post patient use of positioner, survey to take a maximum of 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Positioning Needs of Patients | Evaluate if the current prone positioner design improves positioning needs of patients who have tracheostomies and are ventilator dependent | Observed during the 45 min when patient is in Prone Positioner |
| Aesthetic and Usability Feedback of Prone Positioner |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brandi Dorton, DPT, NTMTC | Contact | 8162343380 | bbdorton@cmh.edu | |
| Jennifer A Marshall, MPH, RN | Contact | jamarshall@cmh.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brandi Dorton, DPT, NTMTC | Children's Mercy Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Kansas City | Recruiting | Kansas City | Missouri | 64108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29096238 | Result | Hewitt L, Stanley RM, Okely AD. Correlates of tummy time in infants aged 0-12 months old: A systematic review. Infant Behav Dev. 2017 Nov;49:310-321. doi: 10.1016/j.infbeh.2017.10.001. Epub 2017 Nov 2. | |
| 17707512 | Result | Rocha NA, Tudella E. The influence of lying positions and postural control on hand-mouth and hand-hand behaviors in 0-4-month-old infants. Infant Behav Dev. 2008 Jan;31(1):107-14. doi: 10.1016/j.infbeh.2007.07.004. Epub 2007 Aug 17. |
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Individual Participant Data (IPD) elements will only be made available to the study team within Children's Mercy Kansas City. These IPD will be protected to greatest extent possible by the study team through the use of encrypted files and password protected sign-ons.
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Infants between the ages >44 weeks gestational age to 18 months of age with complex medical conditions, particularly those with tracheostomies
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Gather aesthetic and usability feedback on the prone positioner from families, therapists, and nursing staff |
| Post patient use of positioner, survey to take a maximum of 10 minutes |