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NCT Number: NCT06018064

Investigating Fit and Satisfaction of the Prone Positioner

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.

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Key information

Conditions

Age range

44 week–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location status: Recruiting

Location contact

Brandi Dorton, DPT, NTMTC

CONTACT

[email protected]

Jennifer Marshall, MPH, RN

CONTACT

[email protected]

9132449566

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prone Positioner

Device

An innovative device to allow for infants to be supported while in the prone position

Primary outcomes

  1. Fit and Size of Prone Positioner

    Time frame: 45 minutes

    Evaluate the fit and size of the prone positioner prototype with infants with tracheostomies of varying ages/sizes

Secondary outcomes

  1. Parental Satisfaction with Prone Positioner

    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?)

Other outcomes

  1. Improvement in Positioning Needs of Patients

    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

  2. Aesthetic and Usability Feedback of Prone Positioner

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Brandi Dorton, DPT, NTMTC

CONTACT

[email protected]

8162343380

Jennifer A Marshall, MPH, RN

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Aug 30, 2023
Registry last updated
Dec 5, 2025

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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