JessieHug Feasibility and Usability Assessment (NCT06466148) | Clinical Trial Compass
TerminatedNot Applicable
JessieHug Feasibility and Usability Assessment
Stopped: Low patient accrual.
United States31 participantsStarted 2024-04-10
Plain-language summary
The goal of this clinical trial is to evaluates the usability, tolerability, and clinical accuracy of the JessieHug device, a wearable medical device for newborns and infants that collects physiological data. The main questions it aims to answer are:
* Is the device easily usable for parents of newborns and infants?
* Is the device tolerable when worn by infants and are there any safety concerns?
* Is the device able to collect clinically accurate physiologic data compared to a FDA-cleared reference device?
Participants will:
* Place the JessieHug device on their infant two times a week and complete surveys to assess usability, tolerability and safety.
* Have one session where the JessieHug device will be worn at the same time as reference device to determine accuracy.
Who can participate
Age range
0 Months – 4 Months
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
. Healthy neonates and infants, with cohorts defined by the following age ranges:
. newborn (0 weeks and 0/7 days to 0 weeks and 5/7 days),
. 2-month (6 weeks and 0/7 days to 11 weeks and 6/7 days),
. 4-month (14 weeks and 0/7 days to 19 weeks and 6/7 days)
. Born after 37 0/7 weeks of pregnancy
. Parent or legal guardian at time of discharge is able to understand and provide consent for participation
. Parent or legal guardian at time of discharge is willing and able to participate in study procedures for the duration of the study
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
Evaluating usability of the JessieHug measured by a System Usability Survey
Timeframe: Every other week for through study completion (8 weeks)
2
Evaluating tolerability of the JessieHug measured by the Face, Legs, Activity, Cry, and Consolability Scale (FLACC) survey, which is an observer reported outcomes (ObsRO) survey.
Timeframe: Every week for through study completion (8 weeks)
3
Evaluating safety of the JessieHug assessed through a survey assessing adverse events and pain.
Timeframe: Every week for through study completion (8 weeks)
4
Percent caregiver completing all steps without errors
Timeframe: At baseline
Trial details
NCT IDNCT06466148
SponsorWeill Medical College of Cornell University