Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT05975658
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
2 Years
Study:
NCT05975658
Study Brief:
Protocol Section:
NCT05975658