CompletedNo phase
WIReD: Wireless Interstage Remote Device Study
Key facts
- Who runs it
- Children's Mercy Hospital Kansas City
- Where
- Kansas City, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 13 people enrolled
- Started
- 30 Sept 2023
- Ended
- 3 Dec 2024
- Type of study
- Observational
- Treatments tested
- Gabi SmartCare Pediarity System [Gabi Band, Gabi Monitor App, Gabi Analytics]
- Record updated
- 5 December 2024
Who can take part
- Age
- Up to 2 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Study participants will be parent-child dyads - pediatric patients who have been diagnosed with congenital, arrhythmic, or acquired heart disease at Children's Mercy Kansas City
- Age criteria for children: after birth and who are less than two years of age at the time of being approached
- The child of the parent-child dyad must be planned from the clinical standpoint prior to approach for discharge home with standard of care oxygen saturation/heart rate/pulse oximeter for remote patient monitoring population - and followed with the CHAMP application in the home setting
- CHAMP App CM IRB 15030113 - Pediatric patients may be followed by the CHAMP Clinical team or enrolled in the CHAMP App Cardiac Study
Who cannot take part
- Over two years of age at the time of being approached for study participation
- Families that do not speak English or Spanish (languages supported by the devices)
- Families that do not have access to a Wi-Fi network at home
Where in United States
- Children's Mercy HospitalKansas City, United StatesNo longer taking part
About the trial
What the trial wants to find out
A mixed-methods study will be used to evaluate the use of standard of care periodic pulse oximetry by parents/LAR and the feasibility of the collection of physiologic data related to the use of the Pediarity System. This system includes the Gabi Band and software platform (Gabi Analytics).
Treatments tested
- Gabi SmartCare Pediarity System [Gabi Band, Gabi Monitor App, Gabi Analytics]
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 5 December 2024