Primary ObjectiveTo investigate the utility of early detection of SARS-CoV-2 and other infections in pediatric transplant patients using clinical-grade wearable biosensors that remotely monitor heart rate variability, blood pressure, skin temperature, and O2 saturation.
Study DesignThis prospective, observational biometric study will use existing early infection detection algorithms and assess newer transplant-specific iterations. Subjects will wear devices to monitor biometrics and complete very brief daily REDCap symptom forms via our mobile application. We have reviewed a list of high priority covariates and confounders which may impact the biometric being measured, including:
- Primary disease
- Baseline vitals & PMH
- Hx of transplants and graft loss
- Maintenance immunosuppressive medications (Tacrolimus/Sirolimus levels)
- Viral surveillance
ParticipantsCHOP and our affiliate sites will contact patients and families for enrollment at specific Transplant sites. The study is not yet open for broad enrollment. The total enrollment varies by organ cohort and will include household members such as non-transplanted siblings (2-21 years old) and adult parents/caregivers.
InterventionsThe phase I study has no interventions, as its main objective is assessing the feasibility and validity of early infection detection algorithms.
Main Outcome MeasuresDetection of SARS-CoV-2, Influenza, BKV, EBV, CMV, and other infections. Secondary outcome measures include post-transplant metabolic function, immune-related complications, and organ function.
My Personal Health Dashboard (MyPHD)The MyPHD app was created by Dr. Snyder’s Research Group at Stanford. This app will link to devices and university servers. MyPHD was created with a secure computational and storage framework.
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