JessieHug Feasibility and Usability Assessment

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: SIDS

Treatments: Device: JessieHug

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06466148

23-08026420

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 4 months old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 3 patient groups

Newborn Cohort

Experimental group

Description:

The JessieHug device will be placed on infants two times a week to determine usability, tolerability and safety. Clinical accuracy will be assessed in one inpatient (newborn cohort) or outpatient (2 month and 4 month cohorts) session.

Treatment:

Device: JessieHug

2 month Cohort

Experimental group

Description:

The JessieHug device will be placed on infants two times a week to determine usability, tolerability and safety. Clinical accuracy will be assessed in one inpatient (newborn cohort) or outpatient (2 month and 4 month cohorts) session.

Treatment:

Device: JessieHug

4 month Cohort

Experimental group

Description:

The JessieHug device will be placed on infants two times a week to determine usability, tolerability and safety. Clinical accuracy will be assessed in one inpatient (newborn cohort) or outpatient (2 month and 4 month cohorts) session.

Treatment:

Device: JessieHug