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.
Infants discharged from the hospital or NICU, particularly those born preterm or with low birth weight, are at increased risk for feeding difficulties, growth faltering, dehydration, and unplanned readmission. Standard follow-up care relies on scheduled in-office weight checks and caregiver self-report, which may not capture early warning signs. The Woddle Smart Changing Pad integrates a precision weight scale with diaper event, feeding, and sleep tracking into a single connected platform; a paired mobile application allows caregivers to record and view infant health data, and a provider dashboard allows clinicians to remotely monitor trends. In this single-arm, 12-week pilot, caregiver-infant dyads used the device at home while participating providers monitored data via the dashboard. The study assessed caregiver adherence, caregiver and provider usability, agreement between device and clinic reference weights, and descriptive secondary outcomes including weight trajectory, healthcare utilization, and caregiver- and provider-reported experience.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
12
A sensor-enabled infant changing pad with an integrated precision weight scale, capturing diaper events, feeding sessions, and sleep duration through caregiver input and sensors. Data sync to a companion mobile application and a secure, HIPAA-compliant provider dashboard.
HITLAB, 175 Varick St 4th floor New York
New York, New York, United States
Pediatrics 2000 III Pllc, 505 West 168th St Fl.1 NY
New York, New York, United States
Vermenton Pediatrics, 1055 E Tremont Ave, Bronx
The Bronx, New York, United States
Caregiver adherence
Proportion of study days (of 84) with valid device use.
Time frame: 12 weeks.
Agreement between device and clinic reference weight
Mean bias, Bland-Altman limits of agreement, and intraclass correlation coefficient (ICC) between paired device and clinic scale weights.
Time frame: Baseline, Week 6, and Week 12.
Data sync success rate
Proportion of expected device-to-dashboard data syncs successfully received
Time frame: 12 weeks.
Caregiver System Usability Scale (SUS) score
10-item, 5-point Likert usability scale (range 0-100).
Time frame: Week 6 and Week 12.
Infant weight gain trajectory
Weekly weight gain (g/day) over the study period.
Time frame: 12 weeks
Nadir weight
Percent weight loss from birthweight; proportion of infants with ≥10% loss
Time frame: 12 weeks
Healthcare utilization
Counts of unplanned clinic visits, emergency department visits, rehospitalizations, and provider calls.
Time frame: 12 weeks.
Caregiver confidence and stress
Parenting Sense of Competence Scale (PSOC) and 0-10 confidence/stress scales.
Time frame: Baseline vs. Week 12.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Provider usability and satisfaction
Provider SUS and dashboard survey (Technology Acceptance Model - perceived usefulness, ease of use, behavioral intention).
Time frame: Week 12.
Provider actions triggered by remote data
Number and type of clinical actions (e.g., check-in calls, feeding adjustments) informed by dashboard review.
Time frame: 12 weeks.