Feasibility, Usability, and Validation of the Woddle Smart Changing Pad for Infant Monitoring Post-Hospital Discharge: A Pilot Study

Inclusion Criteria

INCLUSION CRITERIA (INFANT) * Born at gestational age 23-0 to 42-0 weeks * Discharged from NICU or couplet/newborn care within 45 days prior to planned enrollment * Clinical indication for post-discharge growth or feeding follow-up, or documentation of a qualifying ICD-10/P-code (perinatal/growth-related, feeding/nutrition, growth/weight monitoring, or follow-up/well-newborn codes) * Twins/triplets permitted (one device shared per family) INCLUSION CRITERIA (CAREGIVER) * Age ≥ 18 years * Primary language English, Spanish, or Chinese * Access to a smartphone compatible with the study app and home Wi-Fi/data plan * Willing and able to complete study tasks over 12 weeks of home monitoring EXCLUSION CRITERIA (INFANT) * Rehospitalized within 7 days prior to planned enrollment * Conditions making participation inappropriate or unsafe in the opinion of the treating clinician or investigator * Enrolled in another interventional study that conflicts with device monitoring or study endpoints EXCLUSION CRITERIA (CAREGIVER) * Declines or is unable to provide informed consent * Unable or unwilling to operate the device/app after training and reasonable technical support * Unwilling to allow collection of study data or provider/staff access to relevant clinical event data