NCT06018064

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
28mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Sep 2023Sep 2028

First Submitted

Initial submission to the registry

August 25, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

September 21, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

3.9 years

First QC Date

August 25, 2023

Last Update Submit

December 1, 2025

Conditions

Infant Development

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Parental Satisfaction with Prone Positioner

    Post patient use of positioner, survey to take a maximum of 10 minutes

Other Outcomes (2)

  • Improvement in Positioning Needs of Patients

    Observed during the 45 min when patient is in Prone Positioner

  • Aesthetic and Usability Feedback of Prone Positioner

    Post patient use of positioner, survey to take a maximum of 10 minutes

Study Arms (1)

Interventional Arm

EXPERIMENTAL

Subjects who are placed in the Prone Positioner for evaluation

Device: Prone Positioner

Interventions

Prone PositionerDEVICE

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

Interventional Arm

Eligibility Criteria

Age44 Weeks - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

RECRUITING

Related 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.

    PMID: 29096238RESULT

  • 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.

    PMID: 17707512RESULT

Study Officials

  • Brandi Dorton, DPT, NTMTC

    Children's Mercy Kansas City

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandi Dorton, DPT, NTMTC

CONTACT

8162343380bbdorton@cmh.edu

Jennifer A Marshall, MPH, RN

CONTACT

jamarshall@cmh.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Infants between the ages \>44 weeks gestational age to 18 months of age with complex medical conditions, particularly those with tracheostomies
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 25, 2023

First Posted

August 30, 2023

Study Start

September 21, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Last Updated

December 5, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual Participant Data (IPD) elements will only be made available to the study team within Children's Mercy Kansas City. These IPD will be protected to greatest extent possible by the study team through the use of encrypted files and password protected sign-ons.

Locations

US(1)