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Completed

NCT Number: NCT07718516

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

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.

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Key information

Conditions

Infant Nutrition Disorders Body Weight Body Weight Changes Female Urogenital Diseases and Pregnancy Complications Nutrition Disorders Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Postnatal Care Pregnancy Complications Premature Birth Signs and Symptoms Urogenital Diseases Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HITLAB, 175 Varick St 4th floor New York, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Woddle Baby smart changing pad and app

Primary outcomes

  1. Caregiver adherence

    Time frame: 12 weeks.

    Proportion of study days (of 84) with valid device use.

  2. Agreement between device and clinic reference weight

    Time frame: 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.

  3. Data sync success rate

    Time frame: 12 weeks.

    Proportion of expected device-to-dashboard data syncs successfully received

  4. Caregiver System Usability Scale (SUS) score

    Time frame: Week 6 and Week 12.

    10-item, 5-point Likert usability scale (range 0-100).

Secondary outcomes

  1. Infant weight gain trajectory

    Time frame: 12 weeks

    Weekly weight gain (g/day) over the study period.

  2. Nadir weight

    Time frame: 12 weeks

    Percent weight loss from birthweight; proportion of infants with ≥10% loss

  3. Healthcare utilization

    Time frame: 12 weeks.

    Counts of unplanned clinic visits, emergency department visits, rehospitalizations, and provider calls.

  4. Caregiver confidence and stress

    Time frame: Baseline vs. Week 12.

    Parenting Sense of Competence Scale (PSOC) and 0-10 confidence/stress scales.

  5. Provider usability and satisfaction

    Time frame: Week 12.

    Provider SUS and dashboard survey (Technology Acceptance Model - perceived usefulness, ease of use, behavioral intention).

  6. Provider actions triggered by remote data

    Time frame: 12 weeks.

    Number and type of clinical actions (e.g., check-in calls, feeding adjustments) informed by dashboard review.

Sponsors and collaborators

Lead sponsor

Stan Kachnowski

Industry

Collaborators

  • Woddle Baby Inc.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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