Evaluating the Fit and Satisfaction of a Device for Infants with Tracheostomies
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
This study is testing a new device for infants with tracheostomies to see if it fits well and makes tummy time more comfortable and enjoyable for both the babies and their caregivers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 44 Weeks to 24 Months |
| Sex | All |
| Sponsor | Children's Mercy Hospital Kansas City Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT06018064 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of a Prone Positioner for infants with tracheostomies, focusing on its fit, comfort, and satisfaction during tummy time. Participants will be monitored while using the device, and their parents and healthcare providers will provide feedback through surveys. The study aims to assess how well the device allows for ventilation and the overall experience of both infants and caregivers. The research team will ensure that trained staff are present at all times to support the infants during the assessment.
Who should consider this trial
Good fit: Ideal candidates include infants aged over 44 weeks gestational age to 24 months with tracheostomies who are currently hospitalized in the PICU or NICU.
Not a fit: Patients who are medically unstable or over 24 months of age will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life for infants with tracheostomies by improving their ability to engage in tummy time safely.
How similar studies have performed: While similar studies on positioning devices for infants exist, this specific approach to evaluating the Prone Positioner is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kansas City, Missouri
- Children's Mercy Kansas City — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Brandi Dorton, DPT, NTMTC — Children's Mercy Kansas City
- Study coordinator: Brandi Dorton, DPT, NTMTC
- Email: bbdorton@cmh.edu
- Phone: 8162343380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.