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Prone Positioner Device for Infant Development

N/A

Recruiting

Led By Brandi Dorton, DPT, NTMTC

Research Sponsored by Children's Mercy Hospital Kansas City

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English speaker

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 45 minutes

Awards & highlights

Study Summary

This trial aims to evaluate the effectiveness of a device to help infants with trachs participate in tummy time. Participants will be monitored for comfort/satisfaction, and parents/providers will give feedback on the device.

Who is the study for?

This trial is for inpatient infants with tracheostomies, aged >44 weeks gestational to 18 months, in the PICU or NICU. It includes various sizes/weights and any race/ethnicity. English-speaking caregivers and CM therapists unfamiliar with the device can participate. Excluded are infants over 18 months, medically unstable, recent surgery with complications, or upper extremity fractures.Check my eligibility

What is being tested?

The study tests the Prone Positioner's fit and satisfaction for infants with trachs during tummy time. It evaluates if it allows proper ventilation while used and gathers aesthetic feedback from families and healthcare providers through surveys.See study design

What are the potential side effects?

While not a medication trial, potential side effects may include discomfort or dissatisfaction with the Prone Positioner use among infants or difficulty maintaining adequate ventilation while in the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 45 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~45 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 45 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fit and Size of Prone Positioner

Secondary outcome measures

Parental Satisfaction with Prone Positioner

Other outcome measures

Aesthetic and Usability Feedback of Prone Positioner

Improvement in Positioning Needs of Patients

Trial Design

1Treatment groups

Experimental Treatment

Group I: Interventional ArmExperimental Treatment1 Intervention

Subjects who are placed in the Prone Positioner for evaluation

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor

245 Previous Clinical Trials

935,769 Total Patients Enrolled

1 Trials studying Infant Development

11 Patients Enrolled for Infant Development

Brandi Dorton, DPT, NTMTCPrincipal InvestigatorChildren's Mercy Kansas City

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do individuals aged over 40 have the opportunity to take part in this examination?

"This research study is only available to those aged 44 weeks and 18 months. Those outside this age range may still find clinical trials, with 33 open for under 18s and 8 for seniors over 65 years old."

Answered by AI

How extensive is the participant pool for this clinical trial?

"Indeed, information published on clinicaltrials.gov supports the notion that this experiment is still searching for enrollees. The project was initially posted on September 21st 2023 and has been recently updated as of October 4th 2023. A total of 30 participants must be found at a single medical centre."

Answered by AI

Are there any available openings for this research experiment?

"Affirmative. According to clinicaltrials.gov, this medical study has commenced recruiting and was initially posted on September 21st 2023. The most recent update occurred on October 4th 20203, with 1 location currently seeking 30 volunteers for the trial."

Answered by AI

What criteria must be fulfilled for someone to qualify as a participant in this trial?

"This trial is recruiting 30 infants aged between 44 weeks and 18 months old. To meet the inclusion criteria, they must be male or female, either located in a PICU or NICU with tracheostomies of varying sizes/weights, any race/ethnicity as long as English-speaking; also their caregivers need to approve, CM Occupational Therapists (OTs), Physical Therapists (PTs) ,and Speech therapists (STs) who have not used this new prone positioner device before."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Investigating Fit and Satisfaction of the Prone Positioner

Brandi Dorton 2023. "Investigating Fit and Satisfaction of the Prone Positioner". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06018064.