Investigating Fit and Satisfaction of the Prone Positioner

Infant Development Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06018064
• Other study ID #: STUDY00002288
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2023
• Est. completion date: September 2026

Study information

• Verified date: January 2024
• Source: Children's Mercy Hospital Kansas City
• Contact: Brandi Dorton, DPT, NTMTC
• Phone: 8162343380
• Email: bbdorton[@]cmh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 44 Weeks to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Infant Development

Intervention

Device:
• Prone Positioner
An innovative device to allow for infants to be supported while in the prone position

Locations

Country	Name	City	State
United States	Children's Mercy Kansas City	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Aesthetic and Usability Feedback of Prone Positioner	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
Primary	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
Secondary	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