JessieHug Feasibility and Usability Assessment
Stopped early · Not applicable
Conditions studied: SIDS
In brief
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.
Key facts
- Study ID
- NCT06466148
- Run by
- Weill Medical College of Cornell University
- People needed
- 31
- Starts
- 2024-04-10
- Expected to finish
- 2026-02-02
- Last updated by the study team
- 2026-04-27
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
- Parent or legal guardian is fluent in English
- Parent or legal guardian has access to the internet
You may not qualify if…
- Low birth weight (< 2500g)
- Any transfer out of the well baby nursery for increased level of care, including admission to the NICU or transitional nursery.
- Clinical indication for prolonged postnatal hospitalization (>4 days)
Where it is running
- NewYork Presbyterian - Weill Cornell Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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