Infant Development
Conditions
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.
Detailed description
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.
Interventions
DEVICEProne Positioner
An innovative device to allow for infants to be supported while in the prone position
Sponsors
Children's Mercy Hospital Kansas City
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Infants between the ages \>44 weeks gestational age to 18 months of age with complex medical conditions, particularly those with tracheostomies
Eligibility
Sex/Gender
ALL
Age
44 Weeks to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fit and Size of Prone Positioner | 45 minutes | Evaluate the fit and size of the prone positioner prototype with infants with tracheostomies of varying ages/sizes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental Satisfaction with Prone Positioner | 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?) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Positioning Needs of Patients | 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 |
| Aesthetic and Usability Feedback of Prone Positioner | 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 |
Countries
United States
Contacts
Primary ContactBrandi Dorton, DPT, NTMTC
Backup ContactJennifer A Marshall, MPH, RN
Outcome results
None listed