[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06018064":3,"trial-entities:NCT06018064":101,"trial-summary:NCT06018064":105},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":45,"minimum_age":46,"maximum_age":47,"healthy_volunteers":15,"eligibility_criteria":48,"std_ages":63,"locations":65,"central_contacts":84,"overall_officials":89,"references":92,"see_also_links":100},"NCT06018064","STUDY00002288","Investigating Fit and Satisfaction of the Prone Positioner","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","RECRUITING","2028-09","2025-12","2025-12-05","2023-09-21","Children's Mercy Hospital Kansas City","OTHER",false,"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:\n\n* What is the fit and satisfaction of the device?\n* Does the device fulfill the goal of allowing infants with trachs participate in tummy time\n* What aesthetic feedback will the study team receive on the prone positioner from families, therapists, and nursing staff.\n\nParticipants will be placed in the Prone Positioner, they will be monitored for their comfort\u002Fsatisfaction 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\u002Fsuggestions for the Prone Positioner.","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.\n\nParents\u002Fguardians 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\u002Fopinions on the device as well.",[19],"Infant Development",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},30,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","Prone Positioner","An innovative device to allow for infants to be supported while in the prone position",[34],"Interventional Arm",[36],{"measure":37,"description":38,"timeFrame":39},"Fit and Size of Prone Positioner","Evaluate the fit and size of the prone positioner prototype with infants with tracheostomies of varying ages\u002Fsizes","45 minutes",[41],{"measure":42,"description":43,"timeFrame":44},"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?)","Post patient use of positioner, survey to take a maximum of 10 minutes","ALL","44 Weeks","24 Months",{"inclusion":49,"exclusion":56,"raw_text":62},[50,51,52,53,54,55],"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\u002Fweights of infants.","Any race\u002Fethnicity","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.",[57,58,59,60,61],"Infants \\> 24 months of age","Infants medically unstable as determined by attending physician in the PICU\u002FNICU or Vent Clinic","Infants with recent cardiac or abdominal surgery who have precautions or complications related to their surgery.","Infants with weightbearing restrictions\u002Ffractures in their upper extremities.","Non-English speakers \\* Wards of the state","Inclusion Criteria:\n\n* 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\u002Fweights of infants.\n* Any race\u002Fethnicity\n* English speaker\n* Males and females\n* Caregivers\n* Children's Mercy (CM) Occupational Therapists (OTs), Physical Therapists (PTs), Speech Therapists (STs) who have not seen the new prone positioner device.\n\nExclusion Criteria:\n\n* Infants \\> 24 months of age\n* Infants medically unstable as determined by attending physician in the PICU\u002FNICU or Vent Clinic\n* Infants with recent cardiac or abdominal surgery who have precautions or complications related to their surgery.\n* Infants with weightbearing restrictions\u002Ffractures in their upper extremities.\n* Non-English speakers \\* Wards of the state",[64],"CHILD",[66],{"facility":67,"status":8,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":81},"Children's Mercy Kansas City","Kansas City","Missouri","64108","United States",[73,77],{"name":74,"role":75,"email":76},"Brandi Dorton, DPT, NTMTC","CONTACT","bbdorton@cmh.edu",{"name":78,"role":75,"phone":79,"email":80},"Jennifer Marshall, MPH, RN","9132449566","jamarshall@cmh.edu",{"lat":82,"lon":83},39.09973,-94.57857,[85,87],{"name":74,"role":75,"phone":86,"email":76},"8162343380",{"name":88,"role":75,"email":80},"Jennifer A Marshall, MPH, RN",[90],{"name":74,"affiliation":67,"role":91},"PRINCIPAL_INVESTIGATOR",[93,97],{"pmid":94,"type":95,"citation":96},"29096238","RESULT","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\u002Fj.infbeh.2017.10.001. Epub 2017 Nov 2.",{"pmid":98,"type":95,"citation":99},"17707512","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\u002Fj.infbeh.2007.07.004. Epub 2007 Aug 17.",[],{"nct_id":4,"conditions":102,"biomarkers":104},[103],"Tracheotomy",[],{"nct_id":4,"found":106,"summary":107,"prompt_version":117},true,{"design":108,"status":109,"heading":110,"summary":111,"follow_up":112,"word_count":113,"commitments":114,"compensation":115,"drugs_mentioned":116},"This is an interventional study involving about 30 participants. It is not specified if the study is randomized or blinded.","completed","Investigating the Prone Positioner for Infants with Tracheostomies","This study is looking at a new device called the Prone Positioner. This device helps infants with tracheostomies (breathing tubes in their windpipe) lie on their stomachs for \"tummy time.\" Researchers want to see how well the Prone Positioner fits different infants and if families, nurses, and therapists are happy with it. They also want to know if the device helps infants with tracheostomies comfortably participate in tummy time and how well they can breathe while using it. The study will involve about 30 infants, aged 44 weeks (gestational age) to 24 months, who are in the PICU (Pediatric Intensive Care Unit), NICU (Neonatal Intensive Care Unit), or Vent clinic at Children's Mercy.","The primary endpoint for fit and size is measured at 45 minutes, suggesting a short follow-up period.",113,"A trained staff member will be present while your infant is placed in the Prone Positioner for a fit test, which lasts about 45 minutes. You and healthcare providers will complete surveys about the device.","Not stated in the trial record.",[31],"v2"]