Investigating Fit and Satisfaction of the Prone Positioner

Launched by CHILDREN'S MERCY HOSPITAL KANSAS CITY · Aug 25, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a special device called the Prone Positioner, which is designed to help infants with tracheostomies (a tube placed in their neck to help them breathe) participate in tummy time safely. The trial aims to find out how well the device fits, how satisfied families and healthcare providers are with it, and whether it helps infants breathe comfortably while lying on their stomachs.

To participate, infants must be between 44 weeks gestational age and 24 months old, and they need to be staying in the Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU) at Children's Mercy. The study is open to infants of any race or gender, and also includes caregivers and therapists who haven’t used the Prone Positioner yet. During the trial, families will be asked about their experiences and thoughts on the device, while their infants will be monitored for comfort and breathing. This study is currently recruiting participants, and it’s a chance to help improve care for infants needing special support.

Gender

ALL

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