Infant Nutrition Disorders, Postnatal Care, Premature Birth, Weight Loss
Conditions
Keywords
digital health, remote patient monitoring, smart scale, neonatal weight monitoring, post discharge care, connected device
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.
Detailed description
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.
Interventions
DEVICEWoddle Smart Changing Pad
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.
Sponsors
Stan Kachnowski
Woddle Baby Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver adherence | 12 weeks. | Proportion of study days (of 84) with valid device use. |
| Agreement between device and clinic reference weight | Baseline, Week 6, and Week 12. | Mean bias, Bland-Altman limits of agreement, and intraclass correlation coefficient (ICC) between paired device and clinic scale weights. |
| Data sync success rate | 12 weeks. | Proportion of expected device-to-dashboard data syncs successfully received |
| Caregiver System Usability Scale (SUS) score | Week 6 and Week 12. | 10-item, 5-point Likert usability scale (range 0-100). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant weight gain trajectory | 12 weeks | Weekly weight gain (g/day) over the study period. |
| Nadir weight | 12 weeks | Percent weight loss from birthweight; proportion of infants with ≥10% loss |
| Healthcare utilization | 12 weeks. | Counts of unplanned clinic visits, emergency department visits, rehospitalizations, and provider calls. |
| Caregiver confidence and stress | Baseline vs. Week 12. | Parenting Sense of Competence Scale (PSOC) and 0-10 confidence/stress scales. |
| Provider usability and satisfaction | Week 12. | Provider SUS and dashboard survey (Technology Acceptance Model - perceived usefulness, ease of use, behavioral intention). |
| Provider actions triggered by remote data | 12 weeks. | Number and type of clinical actions (e.g., check-in calls, feeding adjustments) informed by dashboard review. |
Countries
United States
Outcome results
None listed