Clinical trial NCT06466148: JessieHug Feasibility and Usability Assessment
Official title: JessieHug Feasibility and Usability Assessment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: SIDS
Keywords: medical device
wearable medical device
infants
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Empatica, Inc.
First posted: 2024-06-20
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: This study evaluates the usability, tolerability, and clinical accuracy of the JessieHug device, a wearable medical device for newborns and infants that continuously collects physiological data. Three cohorts of infants will be enrolled: newborn, 2-month, and 4-month groups, with each cohort undergoing data collection over a total of eight (8) weeks. The JessieHug device will be assessed for usability and tolerability through parental surveys while the baby wears the device in home and hospital settings. Clinical accuracy of the device will be evaluated through comparison to an FDA cleared reference device in a single outpatient clinic-based data collection event.

Eligibility 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)

Primary outcomes:
measure: Evaluating usability of the JessieHug measured by a System Usability Survey
timeFrame: Every other week for through study completion (8 weeks)
measure: 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)
measure: Evaluating safety of the JessieHug assessed through a survey assessing adverse events and pain.
timeFrame: Every week for through study completion (8 weeks)
measure: Percent caregiver completing all steps without errors
timeFrame: At baseline
Secondary outcomes:
measure: Validating the clinical accuracy of the physiological parameters measured by the JessieHug (SpO2) against FDA-cleared reference devices.
timeFrame: One session, up to 4 hours, during study period, up to 8 weeks.
measure: Validating the clinical accuracy of the physiological parameters measured by the JessieHug (pulse rate) against FDA-cleared reference devices.
timeFrame: One session, up to 4 hours, during study period, up to 8 weeks.
measure: Validating the clinical accuracy of the physiological parameters measured by the JessieHug (respiratory rate) against FDA-cleared reference devices.
timeFrame: One session, up to 4 hours, during study period, up to 8 weeks.
Other outcomes:
Locations:
city: New York
country: United States
facility: NewYork Presbyterian - Weill Cornell Medical Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: James M Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: