Feasibility and Validation of a Smart Changing Pad for Home Infant Weight Monitoring After Hospital Discharge | NCT07718516

NCT07718516

Overview

NCT ID: NCT07718516
Lead Sponsor: Stan KachnowskiINDUSTRY
Official Title: Feasibility, Usability, and Validation of the Woddle Smart Changing Pad for Infant Monitoring Post-Hospital Discharge: A Pilot Study
Brief 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.
Conditions: Infant Nutrition Disorders
Weight Loss
Postnatal Care
Premature Birth

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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