Infant DevelopmentNCT06018064
Investigating Fit and Satisfaction of the Prone Positioner
A study testing Prone Positioner in people with Infant Development, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 44 weeks to 24 months
- Conditions the study is for
- Infant Development
- What is being tested?
- Prone Positioner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2023to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 weeks to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer A Marshall, MPH, RN contact
United States1 site, 1 recruiting
- Recruiting
Children's Mercy Kansas City
Kansas City, Missouri, 64108
Brandi Dorton, DPT, NTMTC, bbdorton@cmh.edu
Jennifer Marshall, MPH, RN, 9132449566, jamarshall@cmh.edu
About this study
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
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.
Read the detailed description
A trained member of this study staff will be always present in the patient room during the fit test. For the fit test, a therapist from the study team will takes measurements of the infant and then place the infant in the prone positioner device. At no time will the baby be left alone or unsupported by staff. The study team will assess the physical fit, ease of getting the infant in and out of the device, and the patient's tolerance to being in the positioner.
Parents/guardians will be able to be present while the patient is in the device (if the parents are available and present at the time of fit testing) and immediately following the patient's removal from the device, the parents will be asked to complete a paper survey. The survey will ask for their perceptions of the device, initial reactions, and other qualitative data collected during the fit test. Healthcare providers who are not part of the study team will also be surveyed to obtain their thoughts/opinions on the device as well.
- Conditions
- Infant Development
- Being tested
- Prone Positioner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone PositionerDevice
An innovative device to allow for infants to be supported while in the prone position
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | Subjects who are placed in the Prone Positioner for evaluation Receives: Device: Prone Positioner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fit and Size of Prone Positioner
Evaluate the fit and size of the prone positioner prototype with infants with tracheostomies of varying ages/sizes
Measured: 45 minutes
Secondary outcomes (1)
Parental Satisfaction with Prone Positioner
Evaluate if the prone positioner appeals to parents' satisfaction and trust in its use (i.e., does the device fulfill the goal of allowing infants with trachs participate in tummy time?)
Measured: Post patient use of positioner, survey to take a maximum of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start21 Sep 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Infants between the ages \>44 weeks gestational age to 18 months of age with complex medical conditions, particularly those with tracheostomies
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brandi Dorton, Children's Mercy Hospital Kansas City
- Investigators
- Brandi Dorton, DPT, NTMTC, Principal investigator, Children's Mercy Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018064
- Sponsor's protocol ID
- STUDY00002288
- Status last verified
- Dec 2025
- First submitted
- 25 Aug 2023
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 29096238Rocha 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.
PubMed 17707512
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06018064
- Acronym / sponsor ID
- STUDY00002288
- Conditions
- Infant Development
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A trained member of this study staff will be always present in the patient room during the fit test. For the fit test, a therapist from the study team will takes measurements of the infant and then place the infant in the prone positioner device. At no time will the baby be left alone or unsupported by staff. The study team will assess the physical fit, ease of getting the infant in and out of the device, and the patient's tolerance to being in the positioner.
Parents/guardians will be able to be present while the patient is in the device (if the parents are available and present at the time of fit testing) and immediately following the patient's removal from the device, the parents will be asked to complete a paper survey. The survey will ask for their perceptions of the device, initial reactions, and other qualitative data collected during the fit test. Healthcare providers who are not part of the study team will also be surveyed to obtain their thoughts/opinions on the device as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Infants between the ages >44 weeks gestational age to 18 months of age with complex medical conditions, particularly those with tracheostomies
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Device: Prone PositionerSubjects who are placed in the Prone Positioner for evaluation |
Who may qualify
- Ages
- 44 weeks to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone PositionerAn innovative device to allow for infants to be supported while in the prone position | Device | Interventional Arm |
Primary outcome
Fit and Size of Prone Positioner
Time frame: 45 minutes
Evaluate the fit and size of the prone positioner prototype with infants with tracheostomies of varying ages/sizes
1 secondary outcome
Parental Satisfaction with Prone Positioner
Time frame: Post patient use of positioner, survey to take a maximum of 10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Results publication: PubMed 29096238Hewitt 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.
- Results publication: PubMed 17707512Rocha 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Infant Development
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
Tiny Tummies - A Milk Study
Gut Microbiome, Neurocognitive Correlates of Eating Habits
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
Neurodevelopmental Disorders, Motor Skills Disorders
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer A Marshall, MPH, RN contact
Brandi Dorton, DPT, NTMTC principal investigator
Children's Mercy Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone Positioner in people with Infant Development, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandi Dorton, DPT, NTMTC (8162343380, bbdorton@cmh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fit and Size of Prone Positioner (time frame: 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06018064, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.