RECRUITING

Investigating Fit and Satisfaction of the Prone Positioner

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-09-21
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06018064

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:44 Weeks to 24 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Any race/ethnicity
  3. * English speaker
  4. * Males and females
  5. * Caregivers
  6. * Children's Mercy (CM) Occupational Therapists (OTs), Physical Therapists (PTs), Speech Therapists (STs) who have not seen the new prone positioner device.
  1. * Infants \> 24 months of age
  2. * Infants medically unstable as determined by attending physician in the PICU/NICU or Vent Clinic
  3. * Infants with recent cardiac or abdominal surgery who have precautions or complications related to their surgery.
  4. * Infants with weightbearing restrictions/fractures in their upper extremities.
  5. * Non-English speakers \* Wards of the state

Contacts and Locations

Study Contact

Brandi Dorton, DPT, NTMTC
CONTACT
8162343380
bbdorton@cmh.edu
Jennifer A Marshall, MPH, RN
CONTACT
jamarshall@cmh.edu

Principal Investigator

Brandi Dorton, DPT, NTMTC
PRINCIPAL_INVESTIGATOR
Children's Mercy Kansas City

Study Locations (Sites)

Children's Mercy Kansas City
Kansas City, Missouri, 64108
United States

Collaborators and Investigators

Sponsor: Children's Mercy Hospital Kansas City

  • Brandi Dorton, DPT, NTMTC, PRINCIPAL_INVESTIGATOR, Children's Mercy Kansas City

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-21
Study Completion Date2026-09

Study Record Updates

Study Start Date2023-09-21
Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

  • Infant Development