Infant Nutrition DisordersNCT07718516
Feasibility and Validation of a Smart Changing Pad for Home Infant Weight Monitoring After Hospital Discharge
A study testing Woddle Smart Changing Pad in people with Infant Nutrition Disorders and Weight Loss, run by Stan Kachnowski at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infant Nutrition Disorders, Weight Loss, Postnatal Care
- What is being tested?
- Woddle Smart Changing Pad
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Dec 2025to 13 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
HITLAB, 175 Varick St 4th floor New York
New York, New York, 10014
Pediatrics 2000 III Pllc, 505 West 168th St Fl.1 NY
New York, New York, 10032
Vermenton Pediatrics, 1055 E Tremont Ave, Bronx
The Bronx, New York, 10460
About this study
Official title: 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.
Read the 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.
- Being tested
- Woddle Smart Changing Pad
- Keywords
- digital health, remote patient monitoring, smart scale, neonatal weight monitoring, post discharge care, connected device
- Medical subject headings
- Infant Nutrition Disorders, Weight Loss, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Woddle Smart Changing PadDevice
Also called Woddle Baby smart changing pad and app
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Woddle Smart Changing Pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver adherence
Proportion of study days (of 84) with valid device use.
Measured: 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.
Measured: Baseline, Week 6, and Week 12.
Data sync success rate
Proportion of expected device-to-dashboard data syncs successfully received
Measured: 12 weeks.
Caregiver System Usability Scale (SUS) score
10-item, 5-point Likert usability scale (range 0-100).
Measured: Week 6 and Week 12.
Secondary outcomes (6)
Infant weight gain trajectory
Weekly weight gain (g/day) over the study period.
Measured: 12 weeks
Nadir weight
Percent weight loss from birthweight; proportion of infants with ≥10% loss
Measured: 12 weeks
Healthcare utilization
Counts of unplanned clinic visits, emergency department visits, rehospitalizations, and provider calls.
Measured: 12 weeks.
Caregiver confidence and stress
Parenting Sense of Competence Scale (PSOC) and 0-10 confidence/stress scales.
Measured: Baseline vs. Week 12.
Provider usability and satisfaction
Provider SUS and dashboard survey (Technology Acceptance Model - perceived usefulness, ease of use, behavioral intention).
Measured: 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.
Measured: 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start16 Dec 2025
- Primary completion6 Jul 2026
- Study completion13 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Nutrition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stan Kachnowski
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Woddle Baby Inc.
- Responsible party
- Sponsor-investigator, Stan Kachnowski, Healthcare Innovation Technology Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718516
- Sponsor's protocol ID
- WB-02
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Usability, and Validation of the Woddle Smart Changing Pad for Infant Monitoring Post-Hospital Discharge: A Pilot Study
- ClinicalTrials.gov ID
- NCT07718516
- Acronym / sponsor ID
- WB-02
- Keywords
- digital health, remote patient monitoring, smart scale, neonatal weight monitoring, post discharge care, connected device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stan KachnowskiIndustry (pharma, biotech, devices)
- Collaborators
- Woddle Baby Inc.
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 6 Jul 2026 (actual)
- Study completion
- 13 Jul 2026 (actual)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Woddle Device Group | Experimental | Device: Woddle Smart Changing PadAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Woddle Smart Changing PadAlso: Woddle Baby smart changing pad and appA 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. | Device | Woddle Device Group |
Primary outcome
Caregiver adherence
Time frame: 12 weeks.
Proportion of study days (of 84) with valid device use.
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.
Data sync success rate
Time frame: 12 weeks.
Proportion of expected device-to-dashboard data syncs successfully received
Caregiver System Usability Scale (SUS) score
Time frame: Week 6 and Week 12.
10-item, 5-point Likert usability scale (range 0-100).
6 secondary outcomes
Infant weight gain trajectory
Time frame: 12 weeks
Nadir weight
Time frame: 12 weeks
Healthcare utilization
Time frame: 12 weeks.
Caregiver confidence and stress
Time frame: Baseline vs. Week 12.
Provider usability and satisfaction
Time frame: Week 12.
Provider actions triggered by remote data
Time frame: 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Woddle Smart Changing Pad in people with Infant Nutrition Disorders and Weight Loss, run by Stan Kachnowski at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver adherence (time frame: 12 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.