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

Feasibility, Usability, and Validation of the Woddle Smart Changing Pad for Infant Monitoring Post-Hospital Discharge: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Premature Birth; Weight Loss; Infant Nutrition Disorders; Postnatal Care
• Intervention / Treatment: Device: Woddle Smart Changing Pad

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10014
      • HITLAB, 175 Varick St 4th floor New York
    • New York, New York, United States, 10032
      • Pediatrics 2000 III Pllc, 505 West 168th St Fl.1 NY
    • The Bronx, New York, United States, 10460
      • Vermenton Pediatrics, 1055 E Tremont Ave, Bronx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Woddle Device Group; All enrolled caregiver-infant dyads received the Woddle Smart Changing Pad and companion mobile application for home use over a 12-week period, with data reviewed by participating providers via a secure dashboard.	Device: Woddle 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.; Other Names: Woddle Baby smart changing pad and app

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver adherence	Proportion of study days (of 84) with valid device use.	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.	Baseline, Week 6, and Week 12.
Data sync success rate	Proportion of expected device-to-dashboard data syncs successfully received	12 weeks.
Caregiver System Usability Scale (SUS) score	10-item, 5-point Likert usability scale (range 0-100).	Week 6 and Week 12.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant weight gain trajectory	Weekly weight gain (g/day) over the study period.	12 weeks
Nadir weight	Percent weight loss from birthweight; proportion of infants with ≥10% loss	12 weeks
Healthcare utilization	Counts of unplanned clinic visits, emergency department visits, rehospitalizations, and provider calls.	12 weeks.
Caregiver confidence and stress	Parenting Sense of Competence Scale (PSOC) and 0-10 confidence/stress scales.	Baseline vs. Week 12.
Provider usability and satisfaction	Provider SUS and dashboard survey (Technology Acceptance Model - perceived usefulness, ease of use, behavioral intention).	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.	12 weeks.

Collaborators and Investigators

• Sponsor: Stan Kachnowski
• Collaborators: Woddle Baby Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Actual): July 6, 2026
• Study Completion (Actual): July 13, 2026

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: digital health; remote patient monitoring; smart scale; connected device; neonatal weight monitoring; post discharge care
• Additional Relevant MeSH Terms: Urogenital Diseases; Nutrition Disorders; Female Urogenital Diseases and Pregnancy Complications; Body Weight; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Premature Birth; Weight Loss; Infant Nutrition Disorders
• Other Study ID Numbers: WB-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared beyond the study team due to the small pilot sample size (N≈10 caregiver-infant dyads), which creates a meaningful risk of participant re-identification even after de-identification, given the combination of detailed clinical, demographic, and continuous home-monitoring data collected. Additionally, the informed consent obtained from participating caregivers did not include provisions for depositing or sharing individual-level data with external researchers. De-identified, aggregate findings will be made available through peer-reviewed publication and supplemental materials.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No