Assessment of the JessieHug wearable device for infants
JessieHug Feasibility and Usability Assessment
This study is testing a new wearable device for babies to see how well it works and if parents find it easy and comfortable to use.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 0 Months to 4 Months |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06466148 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the usability, tolerability, and clinical accuracy of the JessieHug device, a wearable medical device designed for newborns and infants that collects physiological data. The study involves three cohorts of infants categorized by age: newborns, 2-month-olds, and 4-month-olds, with data collection spanning eight weeks. Parents will place the device on their infants twice a week and complete surveys regarding its usability and tolerability, while clinical accuracy will be assessed by comparing the device's data to that of an FDA-cleared reference device during a single outpatient session.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy neonates and infants aged from birth to 4 months who are born after 37 weeks of pregnancy.
Not a fit: Patients who may not benefit from this study include those with low birth weight or those requiring increased medical care after birth.
Why it matters
Potential benefit: If successful, this device could enhance monitoring of infants' physiological data, potentially improving early detection of health issues.
How similar studies have performed: Other studies involving wearable medical devices for infants have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy neonates and infants, with cohorts defined by the following age ranges: 1. newborn (0 weeks and 0/7 days to 0 weeks and 5/7 days), 2. 2-month (6 weeks and 0/7 days to 11 weeks and 6/7 days), 3. 4-month (14 weeks and 0/7 days to 19 weeks and 6/7 days) 2. Born after 37 0/7 weeks of pregnancy 3. Parent or legal guardian at time of discharge is able to understand and provide consent for participation 4. Parent or legal guardian at time of discharge is willing and able to participate in study procedures for the duration of the study 5. Parent or legal guardian is fluent in English 6. Parent or legal guardian has access to the internet Exclusion Criteria: 1. Low birth weight (\< 2500g) 2. Any transfer out of the well baby nursery for increased level of care, including admission to the NICU or transitional nursery. 3. Clinical indication for prolonged postnatal hospitalization (\>4 days)
Where this trial is running
New York, New York
- NewYork Presbyterian - Weill Cornell Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: James M Kim, MD — Weill Medical College of Cornell University
- Study coordinator: James M Kim, MD
- Email: jmk9018@med.cornell.edu
- Phone: 978-886-2791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.