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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