Clinical trial NCT06018064: Investigating Fit and Satisfaction of the Prone Positioner
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infant Development
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 44
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Infants between the ages \>44 weeks gestational age to 18 months of age with complex medical conditions, particularly those with tracheostomies
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fit and Size of Prone Positioner
timeFrame: 45 minutes
Secondary outcomes:
measure: Parental Satisfaction with Prone Positioner
timeFrame: Post patient use of positioner, survey to take a maximum of 10 minutes
Other outcomes:
measure: Improvement in Positioning Needs of Patients
timeFrame: Observed during the 45 min when patient is in Prone Positioner
measure: Aesthetic and Usability Feedback of Prone Positioner
timeFrame: Post patient use of positioner, survey to take a maximum of 10 minutes
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
Study officials:
affiliation: Children's Mercy Kansas City
name: Brandi Dorton, DPT, NTMTC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.