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Completed
NCT07718516
Feasibility and Validation of a Smart Changing Pad for Home Infant Weight Monitoring After Hospital Discharge
Conditions: Infant Nutrition Disorders, Weight Loss, Postnatal Care, Premature Birth
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 12
Sponsor: Stan Kachnowski
Location: HITLAB, 175 Varick St 4th floor New York New York New York
Summary
This pilot study evaluates the feasibility, usability, and clinical utility of the Woddle Smart Changing Pad and companion mobile application for infant monitoring following hospital or NICU discharge. The study also compares infant weight measurements obtained using the Woddle scale with those from standard clinical reference scales to assess accuracy and reliability.
Eligibility 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
Source: ClinicalTrials.gov (NCT07718516). StuddyBuddy aggregates publicly available trial information.