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Feasibility and Validation of a Smart Changing Pad for Home Infant Weight Monitoring After Hospital Discharge

CompletedNA

Sponsor: Stan Kachnowski

Conditions: Infant Nutrition Disorders, Weight Loss, Postnatal Care, Premature Birth

Interventions: Woddle Smart Changing Pad

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (3)

New York, New York, United States
New York, New York, United States
The Bronx, New York, United States