Feasibility and Validation of a Smart Changing Pad for Home Infant Weight Monitoring After Hospit… (NCT07718516) | Clinical Trial Compass
CompletedNot Applicable
Feasibility and Validation of a Smart Changing Pad for Home Infant Weight Monitoring After Hospital Discharge
United States12 participantsStarted 2025-12-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Caregiver adherence
Timeframe: 12 weeks.
2
Agreement between device and clinic reference weight