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

NCT07718516 | Completed FDA Device

• 1 other identifier: WB-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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

Keywords

digital health; remote patient monitoring; smart scale; neonatal weight monitoring; post discharge care; connected device

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Infant weight gain trajectory

  12 weeks

• Nadir weight

  12 weeks

• Healthcare utilization

  12 weeks.

• Caregiver confidence and stress

  Baseline vs. Week 12.

• Provider usability and satisfaction

  Week 12.

Study Arms (1)

Woddle Device Group

EXPERIMENTAL

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

Interventions

Woddle Smart Changing Pad DEVICE

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.

Also known as: Woddle Baby smart changing pad and app

Woddle Device Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Stan Kachnowski: lead
• Woddle Baby Inc.: collaborator

Study Sites (3)

HITLAB, 175 Varick St 4th floor New York

New York, New York, 10014, United States

Location

Pediatrics 2000 III Pllc, 505 West 168th St Fl.1 NY

New York, New York, 10032, United States

Location

Vermenton Pediatrics, 1055 E Tremont Ave, Bronx

The Bronx, New York, 10460, United States

Location

MeSH Terms

Conditions

Infant Nutrition Disorders; Weight Loss; Premature Birth

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair of the Healthcare Innovation Technology Laboratory

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 22, 2026
• Study Start: December 16, 2025
• Primary Completion: July 6, 2026
• Study Completion: July 13, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)